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

Model Number	M00556561
Medical Device Problem Codes	Unsealed Device Packaging (1444); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e: this event was reported by a bsc employee.The distributor facility is: (b)(6).Block h6: imdrf device code a020503 captures the reportable event of unsealed device packaging.
Event or Problem Description
It was reported to boston scientific corporation that jagwire was inspected at the distribution facility on (b)(6) 2026.During the inspection, it was reported that the sterile seal of the device pouch peeled off.The reported event may suggest that the sterility of the device has been compromised.There were no patient involved in this event.
Additional Manufacturer Narrative
Block e: this event was reported by a bsc employee.The distributor facility is: (b)(6).Block h6: imdrf device code a020503 captures the reportable event of unsealed device packaging.Block h11: investigation results the returned jagwire was analyzed, and a visual inspection found that the box had a partially lifted peel off lid.The pouches were inspected, and both seals were in good condition.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of unsealed device packaging was not confirmed.The box had a partially lifted peel off lid.The pouches were inspected, and both seals were in good condition.The problem found could have been generated during handling and manipulation of the device during transport or storage could have contributed to the reported event.Therefore, the most probable root cause is no problem detected.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported to boston scientific corporation that jagwire was inspected at the distribution facility on january 26, 2026.During the inspection, it was reported that the sterile seal of the device pouch peeled off.The reported event may suggest that the sterility of the device has been compromised.There were no patient involved in 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: 24423723
• Report Number: 3005099803-2026-00688
• Device Sequence Number: 16096369
• Product Code: OCY
• UDI-Device Identifier: 08714729501374
• UDI-Public: (01)08714729501374(17)281204(10)38114201
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: M00556561
• Device Catalogue Number: 5656
• Device Lot Number: 0038114201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2025
• 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