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

Model Number	M00556581
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporters' facility name is (b)(6).Reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a020504 captures the reportable event of a tear, rip, or hole in the device packaging.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was received by the customer on (b)(6) 2026.It was reported that a perforation was reported on the product packaging, causing the contents to become visible.The device was not used in a procedure.The reported event may suggest that the sterile barrier was compromised due to the damaged packaging.The patient was not present at the time of the event and 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24760559
• Report Number: 3005099803-2026-01191
• Device Sequence Number: 10220150
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: (01)08714729339151(17)281022(10)37780507
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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 Model Number: M00556581
• Device Catalogue Number: 5658
• Device Lot Number: 0037780507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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