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

Model Number	M00557031
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual analysis of the device revealed corewire tip was totally broken off.In addition, the ptfe was peeled.It is likely that the failure mode observed could have been caused due to interaction with the catheter when the physician was trying to insert the guidewire through it.If extra force was applied during usage of the jagwire revolution, this could lead to ptfe peeling as well as the corewire broken.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 revolution was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2020.According to the complainant, during the procedure, there was difficulty advancing the wire through the catheter.The procedure was completed with a new jagwire revolution guidewire.There were no patient complications reported due to this event.This event has been deemed a reportable event based on the investigation finding of corewire broken.

• Brand Name: JAGWIRE REVOLUTION
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10975006
• Report Number: 3005099803-2020-05892
• Device Sequence Number: 4295465
• Product Code: OCY
• UDI-Device Identifier: 08714729935001
• UDI-Public: 08714729935001
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• 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): 12/09/2020

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: 12/19/2022
• Device Model Number: M00557031
• Device Catalogue Number: 56480
• Device Lot Number: 0024965260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR