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	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire protruded from the balloon.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the wire was protruding from the balloon after insertion.A new wolverine was then used and completed the procedure.No patient complications were reported.
Additional 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 in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen and balloon.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a pinhole in the shaft area of the balloon approximately 2mm proximal from the proximal marker band.Liquid was also observed leaking from the tip.An examination of the balloon material identified no issues.The markerbands, blades and tip section 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.A visual and tactile examination of the shaft/hypotube identified a pinhole approximately 2mm proximal from the proximal marker band.The shaft polymer extrusion was torn was also noted to be kinked 43mm distally from the wire exchange port.Multiple hypotube kinks were also identified.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the wire protruded from the balloon.A 10mm x 4.00mm wolverine coronary cutting balloon was selected for use.During procedure when inserting the device, it was noted that the wire protruded from the balloon.The procedure was completed with a different device.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: 10180885
• Report Number: 2134265-2020-07891
• Device Sequence Number: 11533479
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/03/2020

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: 08/18/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024286146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1