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

Model Number	3853
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was noted that patient experienced vessel dissection.The target lesion was located in the calcified left main proximal to left anterior descending artery.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was not able to cross and the shaft was bent approximately 9 inches from the hub.Several unspecified balloon devices were also used.Then, a 6f guidezilla ii was advanced using a 2.5x12mm nc quantum through the left main.The balloon was then removed and another 6mmx3.00mm wolverine coronary cutting balloon was advanced without difficulty.However, it was noted that some dissection occurred.Consequently, the dissection was stented with a 3.5x16mm synergy and ballooned with 3.25 nc to post dilate.No further patient complications were reported and the patient was fine post procedure.
Event or Problem Description
It was noted that patient experienced vessel dissection.The target lesion was located in the calcified left main proximal to left anterior descending artery.A 6mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was not able to cross and the shaft was bent approximately 9 inches from the hub.Several unspecified balloon devices were also used.Then, a 6f guidezilla ii was advanced using a 2.5x12mm nc quantum through the left main.The balloon was then removed and another 6mmx3.00mm wolverine coronary cutting balloon was advanced without difficulty.However, it was noted that some dissection occurred.Consequently, the dissection was stented with a 3.5x16mm synergy and ballooned with 3.25 nc to post dilate.No further patient complications were reported and the patient was fine post procedure.It was further reported the patient was stable post procedure.In the physician opinion the cause of dissection may have been due to the calcified lesion or the inflatable devices.

• 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: 9446899
• Report Number: 2134265-2019-15266
• Device Sequence Number: 2243144
• Product Code: NWX
• UDI-Device Identifier: 08714729888178
• UDI-Public: 08714729888178
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0023928547
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER: GUIDEZILLA; CATHETER: GUIDEZILLA; DILATATION CATHETER: NC QUANTUM; DILATATION CATHETER: NC QUANTUM
• Outcome Attributed to Adverse Event: Required Intervention