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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.
Event or Problem Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.It was further reported the 60% stenosed target lesion was in a mildly tortuous artery.The device was completely removed as the blade was not completely detached from the balloon.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.All four blades were present and fully attached to the balloon as per wolverine specification.No issues were noted with the blades.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a balloon pinhole 3mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres.A visual examination identified no issues with the tip.A visual and tactile examination identified no issues.A visual and tactile examination found the hypotube of the device to be kinked at more than one location.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that blades came off.The target lesion was in the left anterior descending artery.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the cutting balloon blades came off after the inflation.No complications reported and the patient is fine.It was further reported the 60% stenosed target lesion was in a mildly tortuous artery.The device was completely removed as the blade was not completely detached from the balloon.

• 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: 9437455
• Report Number: 2134265-2019-15233
• Device Sequence Number: 11610271
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 01/31/2020

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: 06/12/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0023946569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 01/10/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 12/16/2019; 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1