MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 0033476259

Device Problem Entrapment of Device (1212)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 03/27/2024

Event Type  malfunction  

Event Description

It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the guidewire became stuck in the catheter due to tissue becoming trapped in the guidewire lumen.During the procedure it became difficult to withdraw the catheter and guideiwre back into the sheath, and the physician attempted to advance the guidewire but found they could not.After some more manipulation they were able withdraw the catheter and guidewire out of the body.When examined they found a "small chunk of tissue" when the guidewire was removed from the catheter.A new wire was opened, the catheter was flushed, and the procedure was completed using the original catheter.The catheter is not expected to be returned for analysis as the device was disposed by the hospital.

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.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• 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: 19140175
• MDR Text Key: 340646455
• Report Number: 2124215-2024-23475
• 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: 04/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0033476259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2024
• 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