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

Model Number 3854

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Thrombosis (2100)

Event Date 05/17/2019

Event Type  Injury  

Event Description

It was reported that thrombosis and chest pain occurred.The 90% stenosed target lesion was located in the very calcified and moderately tortuous left anterior descending artery (lad).The length was about 23mm.The vessel size was approximately 25mm in diameter and the patient was referred for an atherectomy where a non bsc device was used.After the atherectomy was done, a 10 mm x 2.50 mm wolverine coronary cutting balloon was advanced to dilate the proximal lad and was inflated twice for 15 seconds at nominal pressure and resulted in a timi 3 flow.A 2.50 x 24 synergy stent was advanced and implanted in the proximal lad.A timi 3 flow resulted after the case and everything was open.The patient was taken off the table and approximately 30 minutes later, the patient was having chest pain.The patient was brought back to the cath lab and a thrombus distal to the stent was noticed.A balloon device was used to inflate this area, and the patient was given heparin to get the activated clotting time (act) up above 300.An aspiration catheter was used and pumped up and resulted in timi 3 flow again.The patient was stable and doing fine.The act that was achieved during the procedure was 285, and preventative was given as well in a mini loading dose.After the procedure, a non bsc guidewire was used to gain access to the vessel.A non bsc guidewire was also used to gain access and later switched to a non bsc guidewire.A non bsc guidewire had been used during the procedure and at the start of the procedure.Then when the patient was brought back, another non bsc guidewire was used.The original device, a 2.50 x 24 synergy stent, was used in the first procedure and this was implanted.A lone stent was implanted in the first part of the procedure.Once they got an optimal result, everything was pulled out and the patient was removed off the table.After the thrombus, a 2.5 mm x 15 mm emerge balloon was advanced to dilate the target lesion and inflated once at nominal pressure for 10 seconds.The procedure was completed with a different device.No patient complications were reported and the patient condition post procedure was good.

• 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 ; 6515827403
• MDR Report Key: 8684347
• MDR Text Key: 147505179
• Report Number: 2134265-2019-06632
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0023299791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2019
• 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
• Patient Age: 70 YR