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	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination identified that the balloon was unfolded which indicated it had been subjected to positive pressure.A visual and microscopic examination was performed on the returned device.The device was received with a 180-degree circumferential tear combined with a 4mm long longitudinal tear stretching from the proximal edge of the distal markerband towards the middle of the balloon.An examination of the balloon material identified no other issues which could potentially have contributed to this complaint.The rate of burst pressure of this wolverine device is 12atm.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No damage or any issues were noted with the hypotube shaft or the polymer extrusion shaft that could have contributed to the complaint incident.A visual and microscopic examination of the section of blades and pads returned for analysis identified no damage or any issues with the blades that could have contributed to the complaint incident.A visual and microscopic examination of the tip was completed.No damage or any issues were noted with the tip that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on the device analysis completed on 21nov2019.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon would not inflate.The procedure was completed with another of the same device.There were no patient complications reported.However, the device analysis revealed that the balloon had a circumferential tear combined with a longitudinal tear.

• 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: 9444277
• Report Number: 2134265-2019-15280
• Device Sequence Number: 2219724
• Product Code: NWX
• UDI-Device Identifier: 08714729888222
• UDI-Public: 08714729888222
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 12/10/2019

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: 02/24/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0023397641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1