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

Model Number M00556581

Device Problems Break (1069); Peeled/Delaminated (1454); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a jagwire was used during an endoscopic retrograde cholangiopancreatography procedure on (b)(6) 2022.During preparation, the guidewire peeled off.The physician replaced it with a second jagwire guidewire, but the same problem occurred.The procedure was completed with the third 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 core wire break.

Manufacturer Narrative

(b)(4).The returned jagwire guidewire was analyzed.Upon visual assessment, the ptfe coating was not peeled.Therefore, the reported ptfe peeled was not confirmed.The pebax was peeled exposing the core wire.The device was checked under magnification, and it was observed that the core wire tip was broken.The broken section was not returned.Based on the condition of the returned device, engineers determined that the problem occurred was due to excess manipulation against this unit.As part of the device manipulation during the procedure an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing damage to the distal end.In addition, the evidence from the product record review did not identify a potential product quality issue or new patient harm.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.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15979998
• MDR Text Key: 308144960
• Report Number: 3005099803-2022-07337
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0028198328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 72 KG