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

Lot Number	3571043933
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was noted that a balloon rupture occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the coronary artery.A trapper exchange balloon was selected for use.During preparation, it was noted that the balloon could not hold pressure as the air bubbles would not stop coming from the catheter into the syringe due to pinhole in the balloon.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was noted that a balloon rupture occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the coronary artery.A trapper exchange balloon was selected for use.During preparation, it was noted that the balloon could not hold pressure as the air bubbles would not stop coming from the catheter into the syringe due to pinhole in the balloon.The procedure was completed with another of same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile inspection revealed no issues with the hypotube and that the balloon had been subjected to positive pressure and was returned in a deflated state.Microscopic examination showed a 5mm tear in the balloon 12 mm proximal from the balloon tip, and no damage to the tip, markerbands or shaft polymer extrusion.An attempt was made to inflate the balloon however the inflation liquid was seen coming from the 5mm tear noted in the distal section.

• 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 ; 7634941632
• MDR Report Key: 21740630
• Report Number: 2124215-2025-18117
• Device Sequence Number: 3981252
• Product Code: DQY
• UDI-Device Identifier: 00191506048938
• UDI-Public: (01)00191506048938(17)260701(10)3571043933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 05/28/2025

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: 07/01/2026
• Device Lot Number: 3571043933
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2024
• 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