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

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

Patient Problem Stroke/CVA (1770)

Event Date 04/08/2024

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device was disposed and 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 the patient presented after a procedure as if a stroke had occurred.Post-procedure using a farawave pulsed field ablation catheter the patient presented as if a stroke had occurred during the procedure.A review of the patient history found that the patient had a nontherapeutic international normalized ratio (inr) of 1.5 prior to the procedure and missed a dose or two of their warfarin.The patient was hospitalized, but no medical intervention was reported.The device is not expected to be returned for analysis due to disposal.

Manufacturer Narrative

B5: describe event or problem - updated.It was indicated that the device was disposed and 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 the patient presented after a procedure as if a stroke had occurred.Post-procedure using a farawave pulsed field ablation catheter the patient presented as if a stroke had occurred during the procedure.A review of the patient history found that the patient had a nontherapeutic international normalized ratio (inr) of 1.5 prior to the procedure and missed a dose or two of their warfarin.The patient was hospitalized, but no medical intervention was reported.The device is not expected to be returned for analysis due to disposal.It was further reported that the stroke symptoms persisted beyond 24 hours without resolution.Intracardiac echocardiography (ice) was used during the procedure.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer (Section G): AGILE MV INC; 3700 st patrick st suite 102; montreal, qc H4E 1 A2; CA H4E 1A2
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19155047
• MDR Text Key: 340742922
• Report Number: 2124215-2024-23697
• 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,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization