MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Device Problem Off-Label Use (1494)

Patient Problems Hemolysis (1886); Renal Failure (2041)

Event Date 03/23/2024

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device was disposed will not be returned for evaluation as the device performed as expected during the procedure and there were no reports of any performance concerns.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that following a pulse field ablation (pfa) procedure using a farawave pfa catheter, the patient presented with elevated creatinine levels.During the procedure pulmonary vein ablations were performed using a farawave pfa catheter, additional ablations of the posterior left atrial wall, the mitral isthmus, and the right atrial posterior wall were also performed.Ablations of the posterior left atrial wall, mitral line, and right atrial posterior wall with the farawave pfa catheter are considered off-label use as the catheter's instructions for use indicate the system is intended only for pulmonary vein isolations.Following the procedure, the patient was admitted to the hospital for elevated creatinine levels and given fluid.The patient also had dark urine and laboratory analysis revealed low haptoglobin levels.The clinical picture was consistent with hemolysis resulting in acute renal failure.The patient underwent temporary dialysis, which has since been halted as the patient condition has improved.The catheter was disposed by the facility and will not be returned as the device performed as expected during the procedure and there were no reports of any performance concerns.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 3715 haven avenue; suite 110; menlo park CA 94025
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19145129
• MDR Text Key: 340677332
• Report Number: 2124215-2024-23974
• 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: 04/19/2024

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: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male