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

Model Number 3852

Device Problems Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 12-jan-2024.It was reported that the balloon failed to deflate.A 15mmx3.50mm wolverine balloon was selected to treat lesion located in the mildly tortuosity and moderately calcified left anterior descending artery (lad).During the procedure, when balloon insertion and inflation were attempted, inflation was not successful.The procedure was completed using another wolverine device and no patient complications were reported.However, return device analysis revealed pinholes on the balloon material.

Manufacturer Narrative

Device evaluated by manufacturer: the returned product consisted of the wolverine cb mr, ous 15mmx3.50mm device.Visual, tactile, microscopic and functional analysis was performed on the device.A detailed microscopic examination of the balloon material identified two pinholes when inflated to rated burst pressure.One was 1mm distal from the distal markerband and the other was 1mm proximal from the proximal markerband.For functional analysis, the device was attached to an encore inflation device which was verified before and after use using the druck gauge.An attempt was then made to inflate the balloon to 12atm as per, wolverine ifu, using an inflation aid attached however, pressure was unable to be maintained as inflation liquid was observed leaking from pinholes.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18554661
• MDR Text Key: 333388564
• Report Number: 2124215-2024-02746
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0031593818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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