MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPPER EXCHANGE DEVICE; Catheter, percutaneous

Model Number	10660
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 09aug2024.It was reported that device failed to inflate.The target lesion was located in the left coronary artery.A trapper was selected for use.During the procedure, the balloon was inflated at 12 atmospheres however balloon inflation did not meet expectations.The device was removed, and procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that a leak was observed from a pinhole burst on the shaft approximately at 905mm from the catheter tip.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received for analysis.A visual, tactile and microscopic examination of the returned catheter was completed.There was evidence of preparation of the catheter, as a contrast medium was detected within the lumen of the catheter.There was no damage noted on the distal tip.There was no damage observed on the balloon.The telescope part of the device was set beyond 100cm mark.The telescope arm moved and functioned as normal with no issues.As part of the investigation the catheter was tried to inflate, and a leak was observed from a pinhole burst on the shaft approximately at 905mm.There was a scratch and pinhole burst on the shaft identified approximately at 905mm when measured from the catheter tip.

• 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): CREGANNA MEDICAL; parkmore west; galway H91 V N2T; EI H91 VN2T
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20131808
• Report Number: 2124215-2024-53841
• Device Sequence Number: 7447441
• Product Code: DQY
• UDI-Device Identifier: 05391526210154
• UDI-Public: 05391526210154
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: 09/12/2024
• Device Model Number: 10660
• Device Catalogue Number: 10660
• Device Lot Number: 3571032172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female