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

Model Number	M00556591
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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: this event was reported by the bsc sales representative.The healthcare facility business name and contact information was not reported and is unknown.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) 2025.It was reported that upon opening, the beginning of the stitches is torn, revealing the contents.The product was not used in a procedure.No further information has been obtained despite good faith efforts.The patient was not present at the time of the event and there were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the bsc sales representative.The healthcare facility business name and contact information was not reported and is unknown.The reported distributor is: (b)(4).Japan zip/postal code: (b)(6) phone number: (b)(6) fax number:(b)(6).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) 2025.It was reported that upon opening, the beginning of the stitches is torn, revealing the contents.The product was not used in a procedure.No further information has been obtained despite good faith efforts.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: 23659786
• Report Number: 3005099803-2025-06331
• Device Sequence Number: 21363311
• Product Code: OCY
• UDI-Device Identifier: 08714729501398
• UDI-Public: (01)08714729501398(17)280711(10)36956252
• 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): 12/31/2025

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: M00556591
• Device Catalogue Number: 5659
• Device Lot Number: 0036956252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/31/2025
• Date Device Manufactured: 07/12/2025
• 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