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

Model Number	81735
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire detached, requiring the detached piece to be snared.A transend guidewire was selected for use in a procedure.During the procedure the guidewire broke in the patient.The physician was able to use a snare to remove the piece that was in the patient.The guidewire was replaced, and the procedure was completed successfully.No further patient complications were reported, and the patient was fully recovered.
Additional Manufacturer Narrative
Date of event was estimated based on aware date.
Additional Manufacturer Narrative
B3.Date of event was estimated based on aware date.
Event or Problem Description
It was reported that the guidewire detached, requiring the piece to be snared.A transend guidewire was selected for use in a procedure.During the procedure the guidewire broke in the patient.The physician was able to use a snare to remove the piece that was in the patient.The guidewire was replaced, and the procedure was completed successfully.No further patient complications were reported, and the patient was fully recovered.It was further reported that the target location of the procedure was in the hepatic artery.The transend guidewire will not be returned, as it was discarded.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16991669
• Report Number: 2124215-2023-25779
• Device Sequence Number: 12508669
• Product Code: DQX
• UDI-Device Identifier: 08714729326243
• UDI-Public: 08714729326243
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/09/2024
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0030688463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown