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

Model Number	M00556561
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code a0401 captures the reportable event of corewire break.The returned jagwire was analyzed.Upon visual assessment, it was observed that the distal tip was kinked as well as a small section was peeled exposing the core wire.Additionally, the core wire was fractured at the distal section.The broken section didn't return.Therefore, the complaint is confirmed for distal tip detached.Based on the condition of the returned device, engineers determined the things that occurred to the guidewire were most likely part of the device manipulation during the procedure, excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the damage on the distal end.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used during a pancreatic stone removal procedure performed on (b)(6) 2022.During the procedure, the 3-5 mm tip detached while seeking inside the pancreatic duct with a cannula and wire, the remains were found in fluoroscopic images and was safely removed from the pancreatic duct.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this event.

• Brand Name: JAGWIRE
• Common Device Name: 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: 16096956
• Report Number: 3005099803-2022-07933
• Device Sequence Number: 17794604
• Product Code: OCY
• UDI-Device Identifier: 08714729501374
• UDI-Public: 08714729501374
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2023

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: 04/26/2025
• Device Model Number: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 0029300966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown