MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556591
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual analysis of the device revealed that the distal tip was totally detached and corewire was broken.Therefore the tip detachment can be confirmed.In addition, the distal section of the jagwire was bent, and ptfe was peeled.It is likely that the failure modes observed could have been caused due to interaction with the snare since the guidewire was grasped with this device.When the guidewire was pull into the endoscope the distal tip got separated and also could contribute to the wire becoming bent and peeled at the distal section.The corewire fracture was observed to have mechanical overload through evidence of bending tension and compression zones.Therefore the most probable cause of this complaint is adverse event related to procedure since it is most likely that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used in the biliary tract during an endoscopic biliary stent placement procedure on (b)(6) 2020.According to the complainant, during the procedure the bile duct stent with a double-balloon endoscope was being placed to treat the patient after r-y reconstruction, the cannulation could not be performed.The physician switched to rendezvous method from ptcd route.Reportedly, the distal tip of the jagwire detached.The procedure time was over 150 minutes and cannulation was not successfully completed therefore the procedure was cancelled.There were no patient complications reported due to this event.This event has been deemed a reportable event based on the investigation results: corewire was broken.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10822362
• Report Number: 3005099803-2020-05258
• Device Sequence Number: 3681076
• Product Code: OCY
• UDI-Device Identifier: 08714729501398
• UDI-Public: 08714729501398
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2023
• Device Model Number: M00556591
• Device Catalogue Number: 5659
• Device Lot Number: 0025491470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1