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

Model Number	M00557021
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that jagwire revolution guidewire 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, jagwire revolution guidewire was advanced through the working channel of sphincterotome and as the technician was manipulating the wire through ampulla the guidewire coating peeled off and corewire was broken.The procedure was completed with a different manufacturers guidewire.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter address): (b)(6).Block h6 (device codes): problem code 1069 captures the reportable event of corewire break.Block h10: visual analysis of the device revealed the core wire was broken at the distal tip.The complaint was confirmed.In addition, ptfe was peeled and distal tip was bent.It is likely the failure modes observed could have been caused due to interaction of the jagwire revolution and the sphincterotome while it was advancing through the working channel during the cannulation.This interaction could lead to the distal tip becoming bent and peeled.Once the tip was peeled, this causes the device to lose some of its lubricity properties, which may cause extra force to be applied which could have led to the wire bending and then it broke.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is adverse event related to procedure since 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 jagwire revolution guidewire 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, jagwire revolution guidewire was advanced through the working channel of sphincterotome and as the technician was manipulating the wire through ampulla the guidewire coating peeled off and corewire was broken.The procedure was completed with a different manufacturers guidewire.There were no reported patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 10822185
• Report Number: 3005099803-2020-05257
• Device Sequence Number: 3681074
• Product Code: OCY
• UDI-Device Identifier: 08714729934998
• UDI-Public: 08714729934998
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 01/04/2021

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: 12/11/2022
• Device Model Number: M00557021
• Device Catalogue Number: 56480
• Device Lot Number: 0024922686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 78