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

Model Number 3854

Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/22/2020

Event Type  Injury  

Event Description

It was reported that the balloon burst and blade detached.A percutaneous coronary intervention was being performed.The 4.0x12 target lesion was located in the moderately tortuous and severely calcified complex proximal right coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon got stuck and burst upon second inflation at 12atm for 10 seconds.The device was tried to pulled out, re-inflated and ballooned on buddy wire.The device was then trapped in a guideliner and snared out.It was also noted that the blade came in contact with plaque just proximal to stent and detached.The procedure was completed with a different device.No further patient complications were 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: 10830628
• MDR Text Key: 215967983
• Report Number: 2134265-2020-15687
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888307
• UDI-Public: 08714729888307
• 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: 11/12/2020

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: 05/29/2022
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0025546644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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): Required Intervention