{ "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. 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ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE CUTTING WIRE WAS ENERGIZED, THE WIRE BROKE AFTER ABOUT FIVE SECONDS. NOTHING DETACHED AND FELL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 44 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE." }, { "mdr_text_key": "316873236", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "BLOCK H6: DEVICE CODE 1069 CAPTURES THE REPORTABLE EVENT OF WIRE BREAK. BLOCK H10: THE RETURNED TRUETOME 44 WAS ANALYZED, AND A VISUAL EVALUATION NOTED THAT THE CUTTING WIRE OF THE DEVICE WAS FOUND DETACHED, BENT AND BLACKENED. IT WAS ALSO OBSERVED THAT THE BREAK IN THE WIRE WAS NOT SMOOTH. A FUNCTIONAL EVALUATION COULD NO BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. NO OTHER ISSUES WITH THE DEVICE WERE NOTED. THE REPORTED EVENT WAS CONFIRMED. ACCORDING TO THE PRODUCT ANALYSIS, THE CUTTING WIRE OF THE DEVICE WAS FOUND DETACHED, BENT AND BLACKENED. BASED ON THE CONDITION OF THE DEVICE, THE OBSERVED DAMAGE MAY HAVE BEEN CAUSED BY EXCESSIVE VOLTAGE OR ENERGIZING THE DEVICE WHEN NOT IN CONTACT WITH TISSUE. BASED ON REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL." }, { "mdr_text_key": "191674294", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "(B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MDR WILL BE FILED." }, { "mdr_text_key": "191674295", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUETOME 44 DEVICE WAS USED IN THE PAPILLA DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE CUTTING WIRE WAS ENERGIZED, THE WIRE BROKE AFTER ABOUT FIVE SECONDS. NOTHING DETACHED AND FELL IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER TRUETOME 44 DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE." } ], "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": "06/08/2020" } ] }