MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3854

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/08/2021

Event Type  Injury  

Event Description

It was reported that the blade detached from the cutting balloon.A 10mm x 3.00mm wolverine coronary cutting balloon was selected for use.The wolverine was advanced and inflated twice at 12 atmospheres.On the third inflation the lesion was not yielding.The wolverine was inflated to a higher pressure (16 atm) for a couple more inflations.The wolverine was removed.The lesion was then successfully dilated with a 3.5 x 12 emerge balloon catheter.A stent was then attempted to cross the lesion multiple times but was unsuccessful.The stent was removed and a guide extension catheter was advanced along with the balloon catheter.The stent was advanced and successfully implanted.Post procedure it was observed that the center piece of the blade was missing on the wolverine cutting balloon.The distal and proximal part of the blade remained attached to the balloon.The physician stated that the detached blade became fixated into the wall and was now covered and trapped behind a stent.There were no complications reported.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12704394
• MDR Text Key: 278567044
• Report Number: 2134265-2021-13510
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0027852409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other