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	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon wings were relaxed.There was evidence of blood in the balloon indicating that the device entered the patient's body.No issues were noted with the balloon of the device that may have potentially contributed to the complaint incident.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.The hypotube shaft of the device was returned in two pieces.A visual and tactile examination identified a hypotube shaft break at approximately 195 mm distal from the distal end of strain relief.This type of damage is consistent with excessive force that could have been applied to the delivery system.A visual and tactile examination identified no issues with the extrusion shaft.
Event or Problem Description
Reportable based on device analysis completed on 05dec2019.It was reported that hub break occurred.During preparation of a 6mmx2.50mm wolverine coronary cutting balloon it was noted that the balloon broke off at the hub outside patient's body.Another wolverine cutting balloon was used to complete the procedure.No complications reported and there was no harm to the patient.However, device analysis revealed hypotube shaft break at 195mm distal from the distal end of strain relief.

• 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: 9463465
• Report Number: 2134265-2019-15576
• Device Sequence Number: 2947805
• Product Code: NWX
• UDI-Device Identifier: 08714729888154
• UDI-Public: 08714729888154
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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
• Report Date (Section B): 12/12/2019

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: 11/23/2019
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0021426804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR