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

Model Number	81715
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.It was possible to see that the guidewire was bent at the tip section, and coating peeled at the polymer section.
Event or Problem Description
Reportable based on device analysis completed on 06-mar-2024.It was reported that difficulty advancing occurred.The target lesion was located in the liver.An 18 165cm gw transend periph guidewire was selected for use in a transarterial chemoembolization procedure.During the procedure, it was noted that the guidewire could not cross the microcatheter normally and was stuck.The procedure was completed with another of the same device.No patient complications were reported, and patient's status was stable.However, device analysis revealed the coating was peeled off.

• 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: 19010946
• Report Number: 2124215-2024-17690
• Device Sequence Number: 18137951
• Product Code: DQX
• UDI-Device Identifier: 08714729326304
• UDI-Public: 08714729326304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2024

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: 05/24/2025
• Device Model Number: 81715
• Device Catalogue Number: 81715
• Device Lot Number: 0031694758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 60 KG