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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a blade detachment occurred.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inserted and inflated three times at 8atm and one time at 10atm.The device was withdrawn in fashion.However, upon removal, it was noted that one of the atheretomes was hanging off of the service of the balloon.The balloon was not inflated at the recommended inflation rate but the device did function properly in the vessel.The procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.
Event or Problem Description
It was reported that a blade detachment occurred.A 15mmx4.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was inserted and inflated three times at 8atm and one time at 10atm.The device was withdrawn in fashion.However, upon removal, it was noted that one of the atheretomes was hanging off of the service of the balloon.The balloon was not inflated at the recommended inflation rate but the device did function properly in the vessel.The procedure was completed with a different device.No patient complications were reported and patient was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned in a deflated state.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 or tip.Examination identified that approximately 5 mm of proximal blade and pad had detached.The detached blade was not returned.There was no damage noted to the other blades.A visual and tactile examination found kinks on several locations of the hypotube shaft.A visual and tactile examination of the extrusion shaft found no issues with the extrusion shaft.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: 12288822
• Report Number: 2134265-2021-09894
• Device Sequence Number: 14620659
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 03/02/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0025289066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR