MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3851

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon wings were in a deflated state.A microscopic examination of the balloon material identified a longitudinal tear in the balloon material.A 1mm long tear was identified over the distal markerband.During an attempt to inflate the balloon, liquid leaked out through the tear site.This confirmed that there was no resistance/blockage in the inflation lumen.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no issues.A visual and tactile examination found no issues.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the distal markerband.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 08mar2023.It was reported that the balloon failed to inflate.The 30-38mm x 2.50-3.00 mm target lesion was located in the calcified trigeminal lesion of the opening of the left main trunk.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon could not inflate.The procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.However, device analysis revealed that a balloon tear occurred.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16591521
• MDR Text Key: 312040764
• Report Number: 2124215-2023-13116
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029222524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 56 KG