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 Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an athrotome had detached.During a procedure, the physician was using a 6mm x 2.50mm wolverine coronary cutting balloon inside of a restenosis of a stent located in the left anterior descending artery.The wolverine would not advance into the lesion and somehow one of the athrotomes had sheared off.All of the device components were removed from the patient.Another wolverine balloon was used to complete the case with no further issues and no patient injury.
Additional Manufacturer Narrative
Device returned to mfr: the wolverine was returned and analysis was completed.The device was received in two sections as the result of a break in the hypotube.A visual and tactile examination identified severe stretching and a complete break in the shaft of the device.The break was located approximately 100mm proximal of the proximal balloon bond.A visual and tactile examination found the hypotube to be kinked at more than one location.A visual examination identified that the balloon was subjected to positive pressure.A visual and microscopic examination identified no damage to the markerbands or blades of the device.A microscopic examination identified damage to the tip of the device.This type of damage is consistent with excess force being applied as a result of meeting resistance during the attempt to cross a lesion.
Event or Problem Description
It was reported an athrotome had detached.During a procedure, the physician was using a 6mm x 2.50mm wolverine coronary cutting balloon inside of a restenosis of a stent located in the left anterior descending artery.The wolverine would not advance into the lesion and somehow one of the athrotomes had sheared off.All of the device components were removed from the patient.Another wolverine balloon was used to complete the case with no further issues and no 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: 8470702
• Report Number: 2134265-2019-03153
• Device Sequence Number: 1650497
• Product Code: NWX
• UDI-Device Identifier: 08714729888154
• UDI-Public: 08714729888154
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 05/10/2019

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: 09/21/2020
• Device Model Number: 3853
• Device Catalogue Number: 3853
• Device Lot Number: 0022691764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1
• Patient Age: 74 YR