MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLAR SHEATH; CATHETER, STEERABLE

Patient Problem Cardiac Perforation (2513)

Event Date 03/11/2024

Event Type  Injury  

Event Description

During a pulmonary vein isolation cryoablation procedure, a cardiac perforation occurred which required surgical repair to stabilize the patient.While performing the transseptal puncture using the non-abbott device (acutus acqucross transseptal needle) and the non-abbott device (boston scientific polar sheath), the left atrial appendage was perforated.The perforation was surgically repaired to stabilize the patient.The physician alleges the transseptal needle was the cause of the perforation.Reference report: mw5152907.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: POLAR SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18921257
• MDR Text Key: 337998106
• Report Number: MW5152908
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Treatment: ACUTUS FLEXCATH CROSS TRANSSEPTAL SOLUTION.