MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Trapper Exchange Device; Catheter, Percutaneous

Lot Number	3571054052
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A trapper exchange device was selected for use.At the course of the procedure, the device was advanced into the guide catheter to facilitate a microcatheter removal.However, it was noted that the balloon appeared to have a small hole that prevented adequate inflation.As the pressure in the inflation device was increased, the pressure gauge kept falling back down as the balloon lost pressure.Upon removing the device from the guide, the physician inspected it closely and saw a pinhole in the balloon which caused it to leak contrast during inflation.The procedure was completed with another of the same device.There were no patient complications.

• 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): QUASAR MEDICAL SINGAPORE PTE LTD; 8 admiralty street; 07 10 admirax; singapore 75743 8; SN 757438
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50716782
• Report Number: 2124215-2026-48451
• Device Sequence Number: 9852941
• Product Code: DQY
• UDI-Device Identifier: 00191506048938
• UDI-Public: (01)00191506048938(17)270610(10)3571054052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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 Lot Number: 3571054052
• 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: 08/19/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 06/10/2025
• 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