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

Model Number	3854
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a focal, calcified lesion in the mid right coronary artery.The lesion was attempted to be dilated with nc trek balloons with no success.A 10mmx3.75mm wolverine coronary cutting balloon would not cross the lesion and the shaft broke.This 10mmx3.50 wolverine coronary cutting balloon was then attempted but also would not cross and the shaft broke.The procedure was successfully completed with a different device without issue or patient injury.
Event or Problem Description
It was reported that a shaft break occurred.A percutaneous coronary intervention was being performed on a focal, calcified lesion in the mid right coronary artery.The lesion was attempted to be dilated with nc trek balloons with no success.A 10mmx3.75mm wolverine coronary cutting balloon would not cross the lesion and the shaft broke.This 10mmx3.50 wolverine coronary cutting balloon was then attempted but also would not cross and the shaft broke.The procedure was successfully completed with a different device without issue or patient injury.
Additional Manufacturer Narrative
A visual and tactile examination identified a complete break in the hypotube of the device.The break was located at approximately 450mm distal to the strain relief.The hypotube was also noted to be severely kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.A microscopic examination identified no damage to the tip of the returned device.A visual and microscopic examination identified no damage to the markerbands or blades of the device.All blades were present and fully bonded to the balloon material.A visual examination identified that the balloon was not subjected to positive pressure.No issues were noted with the balloon that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

• 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: 8310714
• Report Number: 2134265-2019-00815
• Device Sequence Number: 19367614
• Product Code: NWX
• UDI-Device Identifier: 08714729888284
• UDI-Public: 08714729888284
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/12/2019

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: 12/03/2020
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0023029902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: 01/15/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR