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 Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

It was reported that a balloon length was out of specification.A percutaneous coronary intervention was being performed.When the 10mm x 2.5mm wolverine coronary cutting balloon was inflated, it was noted that it had expanded up to the distal marker and exceeded 10mm in length.The procedure was successfully completed with a different wolverine balloon without further issue or patient injury.

Manufacturer Narrative

Device returned to manufacturer: the wolverine cutting balloon was returned and analysis was completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon was inflated to its rated burst pressure of 12atm (atmospheres) without issue.A vacuum was then applied.The inflation device was verified at 12atm (atmospheres), before and after use with a calibrated pressure gauge.This inflation to rated burst pressure of 12atm (atmospheres) was repeated three times with no leaks or drop in pressure noted.Each time the balloon was inflated, the length of the inflated balloon was measured using a calibrated ruler.The working channel length of the balloon was measured at 10mm after each inflation which was within specification.No issues were identified with the balloon material or the profile of the balloon.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was free from damage.No issues were noted which may have potentially contributed to the complaint incident.

Event Description

It was reported that a balloon length was out of specification.A percutaneous coronary intervention was being performed.When the 10mm x 2.5mm wolverine coronary cutting balloon was inflated, it was noted that it had expanded up to the distal marker and exceeded 10mm in length.The procedure was successfully completed with a different wolverine balloon without further issue or patient injury.

• 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: 8773794
• MDR Text Key: 150557563
• Report Number: 2134265-2019-07734
• 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: 08/22/2019

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: 02/07/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0023315635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 06/19/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1