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	08/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.A 10mm x 2.00mm wolverine coronary cutting balloon was selected for use.During procedure, while trying to advance into the lesion the shaft was severely bent.Subsequently, the device was removed and the shaft broke in attempt to straighten the device.The shaft was damage at the proximal section of the catheter that was outside the hemostasis valve.They used guidezilla ii and threader to get enough luminal gain to get the balloon delivered but nothing worked.The patient was taken off the table after reaching maximum safe contrast total and did not receive any further treatment other than plain out balloon angioplasty, but might be brought back to re-attempt if needed.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified a complete break in the hypotube of the device.The break was located at approximately 190mm distal to 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.A visual examination identified that the balloon was not subjected to positive pressure.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip, markerbands or blades of the device.All blades were present and fully bonded to the balloon material.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that shaft break occurred.A 10mm x 2.00mm wolverine coronary cutting balloon was selected for use.During procedure, while trying to advance into the lesion the shaft was severely bent.Subsequently, the device was removed and the shaft broke in attempt to straighten the device.The shaft was damage at the proximal section of the catheter that was outside the hemostasis valve.They used guidezilla ii and threader to get enough luminal gain to get the balloon delivered but nothing worked.The patient was taken off the table after reaching maximum safe contrast total and did not receive any further treatment other than plain out balloon angioplasty, but might be brought back to re-attempt if needed.

• 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: 10535086
• Report Number: 2134265-2020-12420
• Device Sequence Number: 16442155
• Product Code: NWX
• UDI-Device Identifier: 08714729888222
• UDI-Public: 08714729888222
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 11/03/2020

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: 06/11/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0023939934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER EXTENSION - GUIDEZILLA; GUIDE CATHETER EXTENSION - GUIDEZILLA; MICRO DILATATION CATHETER - THREADER; MICRO DILATATION CATHETER - THREADER; GUIDE CATHETER EXTENSION - GUIDEZILLA.; MICRO DILATATION CATHETER - THREADER.
• Patient Age: 66 YR