MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPPER EXCHANGE DEVICE; CATHETER, PERCUTANEOUS

Lot Number	3571040481
Medical Device Problem Codes	Mechanical Problem (1384); Material Rupture (1546); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G1: mfr site address 1: 8 admiralty street 07 10 admirax.
Event or Problem Description
It was reported that the trapper got a pinhole in the balloon.A trapper exchange device was selected for chronic total occlusion.During the procedure, the trapper bent going into the collar of the guide extension.It would not advance past the collar of the guidezilla.Then nominal pressure was applied.The trapper possibly got a pinhole in the balloon while trying to get past the guidezilla and causing the balloon to no longer hold the wire.The procedure was completed with a different device.No further complications were reported.

• Brand Name: TRAPPER EXCHANGE DEVICE
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; singapore 75743 8; SN 757438
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21658373
• Report Number: 2124215-2025-14166
• Device Sequence Number: 8346803
• Product Code: DQY
• UDI-Device Identifier: 00191506048938
• UDI-Public: 00191506048938
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K162253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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: 05/15/2026
• Device Lot Number: 3571040481
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/20/2025
• Date Device Manufactured: 05/15/2024
• 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