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	08/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was fractured.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified righ coronary artery.A 10mm x 2.25mm wolverine coronary cutting balloon was inflated but upon removal it was noted that the device was broken and the balloon was missing.The missing part ended up being in the guide and was removed together with the guide.Stenting was done to complete the procedure.No patient complications reported and the patient was good post procedure.
Event or Problem Description
It was reported that the device was fractured.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified right coronary artery.A 10mm x 2.25mm wolverine coronary cutting balloon was inflated but upon removal it was noted that the device was broken and the balloon was missing.The missing part ended up being in the guide and was removed together with the guide.Stenting was done to complete the procedure.No patient complications reported and the patient was good post procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis with the non-bsc guidewire still inserted through the device.A visual and microscopic examination was performed on the returned device.A visual and tactile examination identified multiple severe kinks along the shaft of the device.A complete break was also noted in the shaft polymer extrusion of the device approximately 1180mm distal to the strain relief at the location of the guidewire exit port.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the shaft that may have contributed to the contributed to the complaint incident.The balloon was observed to be unfolded which indicated it had been subjected to positive pressure.A visual and microscopic examination of the balloon material identified a longitudinal tear in the balloon, beginning 3mm distal to the distal edge of the proximal markerband and extending 7mm distally across the balloon material.A visual and microscopic examination of the balloon material identified no issues that could have contributed to the damage identified.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: 9033473
• Report Number: 2134265-2019-11109
• Device Sequence Number: 13925960
• Product Code: NWX
• UDI-Device Identifier: 08714729888239
• UDI-Public: 08714729888239
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/17/2019

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: 01/10/2020
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0021591617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1