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	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break and difficulty crossing the lesion occurred.The 100% stenosed, chronic total occluded (cto), target lesion was located in the circumferential calcified and moderately tortuous left anterior descending artery (lad).A 15 mm x 3.00 mm wolverine coronary cutting balloon was advanced and a shaft broke due to difficulty crossing significant calcium.The procedure was completed with another device and there was no harm to the patient.
Event or Problem Description
It was reported that a shaft break and difficulty crossing the lesion occurred.The 100% stenosed, chronic total occluded (cto), target lesion was located in the circumferential calcified and moderately tortuous left anterior descending artery (lad).A 15 mm x 3.00 mm wolverine coronary cutting balloon was advanced and a shaft broke due to difficulty crossing significant calcium.The procedure was completed with another device and there was no harm to the patient.The wolverine device was received and analysed.A complete break was identified in the hypotube 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 hypotube of the device approximately 200mm 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 that may have contributed to the complaint incident.The balloon material was folded and had not 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.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: 7798626
• Report Number: 2134265-2018-60224
• Device Sequence Number: 2076768
• Product Code: NWX
• UDI-Device Identifier: 08714729888352
• UDI-Public: 08714729888352
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 10/01/2018

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: 06/10/2020
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0022233500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1