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	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft got broke.The 90% stenosed target lesion was located in the very tortuous and very calcified left main ostial left anterior descending artery.A 15mm x 3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, while advancing into the heart the hypo tube got kinked and eventually the shaft broke outside the tuohy.The device was simply removed by pulling it out and slid out easily.The procedure was completed with a different device.No complications were reported and patient did very well post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the wolverine catheter was received for analysis.The device was received in two sections as the result of a break in the hypotube.A visual and tactile examination found a complete break of the hypotube located approximately 235mm proximal of the strain relief.Multiple severe kinks to the hypotube were also identified.This type of damage is consistent with excessive force being applied to the device.A visual and microscopic examination found no damage or issues with the blades of the device.All blades and blade pads were undamaged and fully bonded to the balloon material.A visual examination identified that the balloon was not subjected to positive pressure.No issues were identified with the balloon material that could potentially have contributed to the complaint incident.A visual examination identified no issues or damage to the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft got broke.The 90% stenosed target lesion was located in the very tortuous and very calcified left main ostial left anterior descending artery.A 15mm x 3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, while advancing into the heart the hypo tube got kinked and eventually the shaft broke outside the tuohy.The device was simply removed by pulling it out and slid out easily.The procedure was completed with a different device.No complications were reported and patient did very well post procedure.

• 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: 9879208
• Report Number: 2134265-2020-03079
• Device Sequence Number: 19687825
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/14/2020

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: 12/10/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0024915392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 03/25/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1