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

Model Number	3855
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon fracture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon was broken in the vessel.No patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was received in two sections as the result of the shaft break.A visual and tactile examination identified a break in the shaft polymer extrusion 90mm proximal from guidewire exit port.Stretching was also evident at the break site.The shaft was also noted to be stretched 5mm distal from the guidewire exit port.An examination of the returned device identified bunching at the distal end of the balloon.Blood was identified on the outside of the balloon and shaft.A visual and microscopic examination of the balloon identified no holes or tears in the balloon.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple hypotube kinks.A microscopic examination identified no damage to the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a balloon fracture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon was broken in the vessel.No patient complications 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: 9920663
• Report Number: 2134265-2020-03899
• Device Sequence Number: 3271880
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/19/2020

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: 12/18/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0024956244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1