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

Model Number	M00556611
Medical Device Problem Codes	Peeled/Delaminated (1454); 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	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used in the sigmoid colon during a colon stent implantation procedure performed on (b)(6) 2023.During the procedure, the guidewire was peeled and detached.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 the core wire broken.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6 (device codes): imdrf device code a0501 captures the reportable event of core wire broken.Block h10: the returned jagwire was analyzed.Upon visual assessment, it was observed that the jagwire ptfe coating area was peeled and accordioned.In addition, the core wire is separated into two sections.Based on the condition of the returned device, engineers determined that the problem observed, is most likely due to 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 the peeled section on the device coating as well as the core wire to be separated into two sections.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
• 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: 17172173
• Report Number: 3005099803-2023-03267
• Device Sequence Number: 12520817
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

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: 02/14/2026
• Device Model Number: M00556611
• Device Catalogue Number: 5661
• Device Lot Number: 0031059970
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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