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 Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, upon second inflation, it was noted that the balloon ruptured at 12atm and was removed without any problem.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

Date of event is an estimated date based off the aware date as the exact event date was not reported.

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, upon second inflation, it was noted that the balloon ruptured at 12atm and was removed without any problem.The procedure was completed with another of the same device.There were no patient complications 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; two scimed place; maple grove MN 55311
• MDR Report Key: 9718031
• MDR Text Key: 180394488
• Report Number: 2134265-2020-01647
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

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: 10/15/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024605118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1