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 Deflation Problem (1149)

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

Event Date 03/02/2021

Event Type  malfunction  

Event Description

It was reported that balloon had deflation trouble a 10mm x 3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon had deflation trouble.Subsequently, the balloon deflated and completed the procedure after several attempts.There were no patient complications reported.

Event Description

It was reported that balloon had deflation trouble a 10mm x 3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon had deflation trouble.Subsequently, the balloon deflated and completed the procedure after several attempts.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.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 an encore inflation unit and positive pressure was applied to inflate the balloon.The balloon could not be inflated due to the presence of solidified media and blood within the device.The device was soaked in a water bath to help soften the media before further inflation attempts were made.Once removed from the bath, the returned device was attached to an encore inflation unit.The balloon was inflated to its rate of burst pressure without issue.No issues were noted with the balloon material or blades of the device upon inflation.The inflation device was verified at 12 atmospheres, before and after use with a pressure gauge.A vacuum was then applied.The balloon of the device deflated within specification.A visual and tactile examination found no kinks or damage to the hypotube of the device.The marker bands, tip and blades of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.No issues were identified during the product analysis.

• 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: 11545962
• MDR Text Key: 241835921
• Report Number: 2134265-2021-03557
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026432054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1