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	Difficult to Remove (1528); Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was difficult to retrieve.The target lesion was located in the left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was used to dilate existing stents after intravascular ultrasound (ivus) was performed.However, there was resistance while passing the balloon through a 6fr non-bsc guide catheter.Subsequently, the balloon was inflated twice in the artery but there was difficulty in retrieving the balloon into the guide.The balloon was then removed without incident but was damaged in the process.The procedure was completed with a different device.No complications were reported.
Event or Problem Description
It was reported that the balloon was difficult to retrieve.The target lesion was located in the left anterior descending artery.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was used to dilate existing stents after intravascular ultrasound (ivus) was performed.However, there was resistance while passing the balloon through a 6fr non-bsc guide catheter.Subsequently, the balloon was inflated twice in the artery but there was difficulty in retrieving the balloon into the guide.The balloon was then removed without incident but was damaged in the process.The procedure was completed with a different device.No complications were reported.It was further reported that the balloon was removed via the guide catheter and that there were no pieces of the balloon left inside the patient's body.The procedure was completed without any incident.

• 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: 9146542
• Report Number: 2134265-2019-11774
• Device Sequence Number: 2656435
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 10/30/2019

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: 11/18/2020
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0022961440
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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: GUIDE CATHETER- 6FR EBU LAUNCHER GUIDE (MDT); GUIDE CATHETER- 6FR EBU LAUNCHER GUIDE (MDT)