MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0033476252

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2024

Event Type  malfunction  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that during an atrial fibrillation (a fib) procedure involving an farawave catheter, the physician experienced difficulty moving the guidewire while attempting to cannulate right superior pulmonary vein (rspv).The non-boston scientific guidewire became stuck while catheter tip was floating in the chamber, so it is not believed to be tissue entrapment.After attempting and failing to free the guidewire, the system was removed, and the guidewire and catheter were replaced.To remove the guidewire, it was needed to remove from distal end of catheter and wire was ripped.For imaging fluoro and ice were used, also the case was performed on non-interrupted anticoagulant.Heparin was given pre transeptal and the act results prior to the event were above 300.After the device was replaced, the procedure was completed without patient complications, the catheter was disposed so it will not be returned.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19197265
• MDR Text Key: 341479062
• Report Number: 2124215-2024-25399
• Device Sequence Number: 1
• Product Code: QZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 0033476252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female