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 Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter shaft broke.The target lesion was located in left anterior descending artery.A 10mmx2.50mm woverine coronary cutting balloon was selected for use.During the procedure, when the balloon was inserted in to the guide catheter, it was noted that the shaft broke.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that the catheter shaft broke.The target lesion was located in left anterior descending artery.A10mmx2.50mm woverine coronary cutting balloon was selected for use.During the procedure, when the balloon was inserted in to the guide catheter, it was noted that the shaft broke.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The device was received in two sections as the result of a break in the hypotube.A visual and tactile examination identified a complete break of the hypotube located approximately 140mm distal of the strain relief.The hypotube was also noted to be kinked at more than one location along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the hypotube that may have contributed to the complaint incident.An examination of the returned device identified that the balloon had not been inflated.No issues were identified with the balloon which could potentially have contributed to this complaint.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 microscopic examination identified no damage to the tip of the device.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: 9234997
• Report Number: 2134265-2019-12864
• Device Sequence Number: 14100512
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 07/05/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024064661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 10/03/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1