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

Model Number 3852

Device Problem Material Rupture (1546)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.A 15mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured upon first inflation at 6atm.The device was removed using normal method without any problem.The procedure was completed with another of the same device.There were no complications reported and the patient was in good condition post procedure.

Event Description

It was reported that a balloon rupture occurred.A 15mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured upon first inflation at 6atm.The device was removed using normal method without any problem.The procedure was completed with another of the same device.There were no complications reported and the patient was in good condition post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic and leakage analysis were performed on the device.No issues identified with the hypotube shaft.No kinks or damages noted on the shaft polymer extrusion.Blood was inside the balloon material.A detailed microscopic examination of the balloon material identified a pinhole in the mid-section of the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.An attempt was made to inflate the balloon to 12 atmospheres as per wolverine instruction for use (ifu) using the encore inflation unit, however, a leak was noted coming from the pinhole in the mid-section of the balloon.The encore inflation device was verified before and after the procedure using a druck gauge.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18377133
• MDR Text Key: 331376168
• Report Number: 2124215-2023-72763
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 0031591869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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