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 Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the wolverine cutting balloon, us 10 mm x 4.00 mm balloon delivery system (sds) was returned for analysis.The balloon was examined and visual examination of the balloon found no tears on the balloon.An attempt was made to inflate the balloon and liquid flushed out through the tip.The balloon material was removed to examine the inner extrusion covered by the balloon material and a puncture hole was observed located at the distal edge of the proximal markerband.The markerbands/tip/blades were examined.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, no raised edges or cracks visible, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The shaft polymer extrusion/hypotube shaft was examined.A visual and tactile examination found no issues with the hypotube shaft of the device, a puncture hole on the extrusion shaft on the distal section of the shaft was noted.During functional testing a shaft leak was observed.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a shaft leak occurred.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During preparation, the balloon appeared damaged when it was removed from the packaging.There were no obvious holes in the balloon.The distal end looked slightly deformed.Shaft appeared to be intact.The balloon was tested outside the patient and it was noted to be leaking.The procedure was completed using another 10mmx4.00mm wolverine coronary cutting balloon.No patient complications were reported.

• 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: 12583607
• Report Number: 2134265-2021-12528
• Device Sequence Number: 3694900
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 09/02/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024367717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/06/2021
• Patient Sequence Number: 1