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 Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a kink and difficulty loading wire occurred.The target lesion was located in the heavily calcified left anterior descending artery (lad).A 15 mm x 3.00 mm wolverine cutting balloon was used during the procedure.The wolverine would not load on the wire and became bent while trying to load it onto the wire.The procedure was completed with another of the same device.No patient complications were reported and there was no harm to the patient.However, the device was returned and analysis revealed a pinhole on the outer shaft.Based on the potential root cause identified, the following attributes were examined: a visual examination identified that the balloon of the device was tightly wrapped and had not been subjected to positive pressure.An examination of the balloon material, tip and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.This wolverine device is recommended for use with a 0.014 inch (0.36mm) guidewire.During the product analysis the investigator was unable to load the device on to a boston scientific 0.014 inch guidewire due to damage to the guidewire lumen.The guidewire used by the customer was not returned for analysis.A microscopic examination identified that the inner guidewire lumen of the shaft was stretched and bunched beginning approximately 2mm distal of the bi-component bond and extending approximately 5mm distally.A pinhole on the outer shaft was also identified located approximately 2mm distal of the bi-component bond.The damage to the inner guidewire lumen and the pinhole on the outer are consistent with the user applying excessive force when attempting to load the device onto the guidewire.A visual and tactile examination identified no issues with the hypotube of the device.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: 7954232
• Report Number: 2134265-2018-61746
• Device Sequence Number: 13798254
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• 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
• Report Date (Section B): 10/10/2018

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: 06/25/2020
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0022302484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1