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

Model Number	81715
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that difficulty removing the guidewire occurred.The target lesion was located in the severely tortuous and mildly calcified internal iliac artery (iia).An 18 165 cm transend guidewire was selected for endovascular aneurysm repair procedure.However, during the procedure, it was noted that the tip of the device got stuck and was damaged upon removal.The procedure was completed with another of the same device.No patient injury reported.
Event or Problem Description
It was reported that difficulty removing the guidewire occurred.The target lesion was located in the severely tortuous and mildly calcified internal iliac artery (iia).An 18 165cm transend guidewire was selected for endovascular aneurysm repair procedure.However, during the procedure, it was noted that the tip of the device got stuck and was damaged upon removal.The procedure was completed with another of the same device.No patient injury reported.It was further reported that the target lesion has no stenosis.The device was bent/kinked.The tip of the wire broke and could not be reshaped.The coil was removed together with the catheter.No additional interventions were performed.For the coil stuck, the catheter was removed, and both the delivery wire and coil were withdrawn outside the body so the procedure could continue.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.

• 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: 20348523
• Report Number: 2124215-2024-61208
• Device Sequence Number: 7931428
• Product Code: DQX
• UDI-Device Identifier: 08714729326304
• UDI-Public: 08714729326304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 10/25/2024

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: 04/28/2026
• Device Model Number: 81715
• Device Catalogue Number: 81715
• Device Lot Number: 0033919754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 04/28/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: 16F DRYSEAL; INTRODUCER SHEATH: 16F DRYSEAL; MICRO CATHETER: BREAKTHROUGH 2 MARKER; MICRO CATHETER: BREAKTHROUGH 2 MARKER
• Patient Sex: Unknown