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

Lot Number	3571053620
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.A trapper exchange device was selected for use.During the procedure, the balloon burst.The device was removed from the patient body, and the procedure was completed with another of the same device.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination revealed that the balloon was subjected to positive pressure and was returned in a deflated state.Contrast media was identified within the balloon material.A shaft kink was identified, 50.3cm proximal from the tip of the device.A detailed microscopic examination of the balloon material identified a pinhole 1.6cm from the distal tip when attempting to inflate.Tip showed no signs of tip damage.A microscopic examination of the markerbands identified no damage.An attempt was made to inflate the balloon however the inflation liquid was seen coming from a pinhole noted 1.6cm from the distal tip.
Event or Problem Description
It was reported that a balloon rupture occurred.A trapper exchange device was selected for use.During the procedure, the balloon burst.The device was removed from the patient body, and the procedure was completed with another of the same device.No 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; 8 admiralty street; 07 10 admirax; singapore 75743 8; SN 757438
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22856688
• Report Number: 2124215-2025-55007
• Device Sequence Number: 15723691
• Product Code: DQY
• UDI-Device Identifier: 00191506048938
• UDI-Public: (01)00191506048938(17)270116(10)3571053620
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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 Lot Number: 3571053620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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