MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 8010921-87

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

Patient Problems Fever (1858); Unspecified Infection (1930); Urinary Retention (2119); Hematuria (2558); Dysuria (2684)

Event Date 01/26/2024

Event Type  Injury  

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

Clinical study name: (b)(6) clinical study id:(b)(6) clinical patient id: (b)(6).It was reported that after a procedure using a farawave ablation catheter the patient experienced cystitis with urinary retention, dysuria, hematuria, and fever prior to discharge from the hospital.A straight catheter was placed to treat the urinary retention, and afterwards the patient had dysuria and hematuria that was most prominent towards the end of urination.The patient also developed a fever that was treated with acetaminophen.Blood tests and a urine culture along with a chest x-ray and an abdominal limited ultrasound were performed as part of the diagnosis of cystitis.The patient was given anti-biotics in the emergency room and was kept for observation until the next day.The complications were considered resolved three days after the procedure.The device is not expected to be returned for analysis due to disposal.

Event Description

Clinical study name: (b)(6) clinical study id: (b)(6) clinical patient id: (b)(6) it was reported that after a procedure using a farawave ablation catheter the patient experienced cystitis with urinary retention, dysuria, hematuria, and fever prior to discharge from the hospital.A straight catheter was placed to treat the urinary retention, and afterwards the patient had dysuria and hematuria that was most prominent towards the end of urination.The patient also developed a fever that was treated with acetaminophen.Blood tests and a urine culture along with a chest x-ray and an abdominal limited ultrasound were performed as part of the diagnosis of cystitis.The patient was given anti-biotics in the emergency room and was kept for observation until the next day.The complications were considered resolved three days after the procedure.The device is not expected to be returned for analysis due to disposal.

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.Information corrected in common device name field from null to cardiac irreversible electroporation system catheter.Added impact code: f08: hospitalization or prolonged hospitalization.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM
• Type of Device: CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
• Manufacturer (Section D): FARAPULSE, INC.; 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: 18784021
• MDR Text Key: 336283964
• Report Number: 2124215-2024-07233
• 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: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2024

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
• Device Lot Number: 8010921-87
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 90 KG