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

Model Number	3854
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: (b)(6).
Event or Problem Description
It was reported that the balloon ruptured.The 99% calcific type stenosed target lesion was located in the proximal right coronary artery.A 10mmx3.00mm wolverine cutting balloon was selected for use.Upon first inflation, it was apparent that the balloon had ruptured due to the inability of the balloon to maintain nominal pressure.The balloon was then removed without any complication and was replaced with another of the same.The new device went to the same location without complication and the desired results were achieved.Stent was placed to cover treated area and patient is resting comfortably post procedure.Per operators impressions, the balloon must have snagged on some calcium and caused the tear initially.
Event or Problem Description
It was reported that the balloon ruptured.The 99% calcific type stenosed target lesion was located in the proximal right coronary artery.A 10mmx3.00mm wolverine cutting balloon was selected for use.Upon first inflation, it was apparent that the balloon had ruptured due to the inability of the balloon to maintain nominal pressure.The balloon was then removed without any complication and was replaced with another of the same.The new device went to the same location without complication and the desired results were achieved.Stent was placed to cover treated area and patient is resting comfortably post procedure.Per operators impressions, the balloon must have snagged on some calcium and caused the tear initially.
Additional Manufacturer Narrative
A2.Age at time of event- 60 plus.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 balloon was found to have solidified media present.In order to soften this media and to allow for the functional inflation test, the device was placed in the water bath.Once removed from the bath, the device was attached to an encore inflation unit, positive pressure was applied, and liquid was observed to be leaking from a balloon pinhole located approximately 4mm proximally from the proximal marker band.An examination of the balloon material and proximal marker band identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine 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 other issues were identified during the product analysis.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10111213
• Report Number: 2134265-2020-07053
• Device Sequence Number: 3817044
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024911341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1