{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 33655 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Malfunction", "report_number": "2134265-2020-04965", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K141521", "date_of_event": "20200401", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "DISTRI" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "JA", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "465229", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "MUSTANG", "generic_name": "CATHETER, BILIARY, DIAGNOSTIC", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "TWO SCIMED PLACE", "manufacturer_d_address_2": "", "manufacturer_d_city": "MAPLE GROVE", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55311", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55311", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20220109", "model_number": "24674", "catalog_number": "24674", "lot_number": "0023166176", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200416", "device_report_product_code": "FGE", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "08714729793342", "udi_public": "08714729793342", "openfda": { "device_name": "Stents, Drains And Dilators For The Biliary Ducts", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5010", "device_class": "2", "registration_number": [ "2134265" ], "fei_number": [ "3002095335" ] } } ], "product_problems": [ "Device Contaminated During Manufacture or Shipping", "Device Contaminated During Manufacture or Shipping" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/14/2020", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250813", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Patient Involvement", "No Patient Involvement" ] } ], "distributor_city": "", "date_report": "20200610", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000763", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200402", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189032960", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(6)." }, { "mdr_text_key": "189032961", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THAT PRESENCE FOREIGN MATTER WAS NOTED IN THE PACKAGE. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, AN OBJECT WHICH SEEMED TO BE BLACK TRASH WAS CONFIRMED IN THE STERILE BAG. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." }, { "mdr_text_key": "316097061", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "(E1) INITIAL REPORTER CITY: (B)(6). DEVICE EVALUATED BY MFR.: A MUSTANG 7.0 X 40, 75CM WAS RETURNED FOR ANALYSIS. THE UNOPENED AND FULLY SEALED INNER POUCH WAS INSPECTED, AND A LOOSE BLACK FOREIGN MATTER (FM) WAS IDENTIFIED IN THE SEALED POUCH. THE LOOSE BLACK FM WAS MEASURED AGAINST A TAPPI CHART AND WAS FOUND TO BE LESS THAN 0.8MM SQUARED WHICH IS WITHIN SPECIFICATION. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS." }, { "mdr_text_key": "316097062", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT PRESENCE FOREIGN MATTER WAS NOTED IN THE PACKAGE. A 7.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, AN OBJECT WHICH SEEMED TO BE BLACK TRASH WAS CONFIRMED IN THE STERILE BAG. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/10/2020" } ] }