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

Model Number	M00556611
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).During the product analysis, ptfe coating section was found detached exposing corewire and there were indentation marks as well as it was twisted/tangled.Therefore, the ptfe peeled area reported by the customer was confirmed.In addition, the tip of the corewire was fractured and bent.It is possible that this problem was caused when the device surface interacted with other medical devices during the procedure or by inserting or removing the guidewire after the pebax coating was activated.It is possible that this problem could have occurred when removing or introducing the guidewire from other devices, in which it became stuck and caused the conditions observed on the device.Based on the condition of the returned device, engineers determined that the problem observed is likely caused by the guidewire being stressed during the procedure.From being in contact with another medical device or was stuck during the procedure and manipulation by the physician, causing part of the ptfe area to dislodge and cause the tip of the corewire to become fractured and bent.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported 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 guidewire was used during an endoscopic retrograde cholangiopancreatography(ercp) procedure on (b)(6) 2021.During the procedure, ptfe coating was peeled.The procedure was completed with a new jagwire guidewire.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of corewire break.

• 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: 12661202
• Report Number: 3005099803-2021-05336
• Device Sequence Number: 1232145
• Product Code: OCY
• UDI-Device Identifier: 08714729172161
• UDI-Public: 08714729172161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 02/26/2024
• Device Model Number: M00556611
• Device Catalogue Number: 5661
• Device Lot Number: 0026882227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1