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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon catheter had broken.It was also reported that after removing the 6mmx2.50mm wolverine mr cutting balloon from the packaging, it broke upon removal from the plastic coil, as they were pulling out the stylet.There was no torsional force, but a routine opening of the balloon.This occurred outside the patients body.The procedure was completed with a different device and there was no patient incident.
Event or Problem Description
It was reported that a balloon catheter had broken.It was reported that after removing the 6mmx2.50mm wolverine mr cutting balloon from the packaging, it broke upon removal from the plastic coil as they were pulling out the stylet.There was no torsional force, but a routine opening of the balloon.This occurred outside the patients body.The procedure was completed with a different device and there was no patient incident.The device was returned for analysis.A complete break was identified in the midshaft the device.A visual and microscopic examination was performed on the returned device.A visual and tactile examination identified multiple severe kinks along the hypotube of the device.A complete break was noted in the midshaft of the device approximately 1180mm distal to the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube or shaft that may have contributed to the complaint incident.The balloon material was folded and did not appear to have been subjected to positive pressure.A visual and microscopic examination was performed on the balloon material and no damage or any issues were noted that could have contributed to the complaint incident.A visual and microscopic examination identified no damage or any issues with the tip, markerbands or blades of the device that could have contributed to the complaint incident.All blades were present and fully bonded to the balloon material.

• 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: 7952824
• Report Number: 2134265-2018-61767
• Device Sequence Number: 427854
• Product Code: NWX
• UDI-Device Identifier: 08714729888154
• UDI-Public: 08714729888154
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/02/2018

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: 02/14/2020
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0021745706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/02/2018
• Patient Sequence Number: 1