MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSEND; WIRE, GUIDE, CATHETER

Model Number	81735
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire was broken during threading.This 0.014/190cm transend guidewire was selected for use to treat a severely tortuous target lesion.During the procedure, the guidewire broke while threading, but it was successfully retrieved using a syringe to create negative pressure for removal.The procedure was completed with this device, and no complications were reported for the patient.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.E1: initial reporter address: (b)(6).
Event or Problem Description
It was reported that the guidewire was broken during threading.This 0.014/190cm transend guidewire was selected for use to treat a severely tortuous target lesion.During the procedure, the guidewire broke while threading, but it was successfully retrieved using a syringe to create negative pressure for removal.The procedure was completed with this device, and no complications were reported for the patient.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.E1: initial reporter address: (b)(6).Device evaluated by mfr: the device was returned for analysis and was inspected according to procedure, peripheral intervention product analysis guidelines, bsc.It was observed that it was detached and bent at distal tip.Based on the evidence, the as reported code guidewire fracture can be confirmed, since the detached found during the product inspection could have contributed to the reported issue.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20583064
• Report Number: 2124215-2024-66853
• Device Sequence Number: 20875702
• Product Code: DQX
• UDI-Device Identifier: 08714729326243
• UDI-Public: 08714729326243
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K941710
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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 Expiration Date: 05/02/2026
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0033953540
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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