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

Model Number 3851

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

It was reported that the balloon ruptured.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.The target lesion was located in the proximal left anterior descending artery (lad).The target lesion was 70% stenosed, moderately calcified, and mildly tortuous.During the procedure, the device could not inflate properly.Upon removal, blood was noted in the balloon material.The device was completely removed from the patient, and the procedure was completed using another of same device.No patient complications were reported.

Manufacturer Narrative

The returned product consisted of the wolverine cutting balloon and catheter.Visual and microscopic analysis of the device showed no defects of damages.The device was then tested for leaks by inflating it, and there were no signs of any leaks as the balloon was able to be inflated with no issues.This investigation is assigned a conclusion code of no problem detected.This code was selected as the most probable complaint cause based on the information available and the condition of the returned device.Device analysis found no issues with the device before or after inflation.

Event Description

It was reported that the balloon ruptured.A 10mmx3.25mm wolverine coronary cutting balloon was selected for use.The target lesion was located in the proximal left anterior descending artery (lad).The target lesion was 70% stenosed, moderately calcified, and mildly tortuous.During the procedure, the device could not inflate properly.Upon removal, blood was noted in the balloon material.The device was completely removed from the patient, and the procedure was completed using another of same device.No patient complications were reported.

• 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: 18955565
• MDR Text Key: 338371565
• Report Number: 2124215-2024-17343
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 05/09/2024

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
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0031847668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/19/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2023
• 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