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

Model Number 3852

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 03/03/2021

Event Type  Injury  

Event Description

It was reported that perforation and cardiac tamponade occurred.A complex, high risk percutaneous coronary intervention was being performed on a 80% stenosed, long calcified and bifurcated lesion in the left anterior descending (lad) artery and second diagonal (d2) artery.The lad was wired using a non-boston scientific guidewire, and the vessel was imaged using opticross.The vessel was found to be highly calcific.It was then rotablated using a rotapro 1.25mm and stented with a synergy 2.5mmx16mm.The d2 was then imaged using the opticross catheter and was also found to be highly fibro-calcific and a proximal diameter of 3-3.5mm.The wolverine 3.0mm x15m coronary cutting balloon was then inflated in the d2 and the lad lesion.It was then noted that a large perforation was visible in the angiogram.The perforation was attempted to be controlled by inflation of a tamponade balloon and covered with three covered stents.The perforation/cardiac tamponade was not able to be controlled and a pericardiocentesis was performed to drain the pericardial effusion.The patient was then transferred for an urgent coronary artery bypass graft (cabg).

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11493728
• MDR Text Key: 240014632
• Report Number: 2134265-2021-03063
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0026329907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention