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	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break had occurred.During a procedure, the 15mm x 4.00mm wolverine coronary cutting balloon shaft broke when the physician attempted to cross the lesion.The device was able to be removed from the patient's body intact.The procedure was completed with a different device without further issue or patient injury.
Additional Manufacturer Narrative
Device returned to manufacturer: the wolverine was returned and analysis was completed.A visual and tactile examination identified a multitude of kinks in the hypotube of the device.This type of damage is consistent with excessive force being applied to the delivery system.No issues were noted with the hypotube that may have contributed to the complaint incident.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.An examination of the balloon identified blood inside the balloon body which is consistent with a leak on the shaft.There was a shaft break identified at 1cm proximal of port bond.It was noted that the shaft was stretched and bunched around the break site.Functional test identified a shaft leak from the break site.A visual and microscopic examination did identify damage to the tip.There was no damage observed to the markerbands or to the blades of the device.All blades were present and fully bonded to the balloon material.Blood was identified within the balloon and lumen which is evidence of a device leak.
Event or Problem Description
It was reported that a shaft break had occurred.During a procedure, the 15mm x 4.00mm wolverine coronary cutting balloon shaft broke when the physician attempted to cross the lesion.The device was able to be removed from the patient's body intact.The procedure was completed with a different device without further issue or patient injury.

• 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: 8754389
• Report Number: 2134265-2019-07146
• Device Sequence Number: 16653677
• Product Code: NWX
• UDI-Device Identifier: 08714729888390
• UDI-Public: 08714729888390
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/05/2019

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: 04/18/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0023668757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 08/05/2019
• Patient Sequence Number: 1