MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 35MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER

Lot Number 8011304-06

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

Upon device return and inspection, no outer abnormalities were observed.The device was inspected on the x-ray to look for any abnormalities that could cause deployment issues.Some kinking of the lead wires was observed.The catheter was returned with a guidewire still inserted.An attempt was made to deploy the device.It was not possible to reach full flower deployment.The device was dissected to look for any abnormalities that could have contributed to the unsuccessful deployment.Adhesive residue was found on the flush lumen, causing the lumen to be stuck to the inside of the catheter shaft (image #4).The flush lumen was also broken and kinked, likely as a result of being adhered to the shaft.The reported event was confirmed.

Event Description

Reportable based on analysis completed on 13-feb-2024.Clinical patient id: (b)(6)./ clinical study: advantage af phase ii pf106.It was reported that a farawave ablation catheter 35mm ide during procedure to treat a persistent atrial flutter, after isolating 2 lateral veins, the physician was unable to deploy the device from basket to full flower position, just a biscuit shape was achieved.Prior to that point the doctor was very quick and may have inadvertently tried to deploy the catheter with the marker in the sheath.3 attempts were made to return catheter to neutral then redeploy but were unsuccessful.To solve the issue the procedure was completed without patient complications using another 35mm farawave.The catheter is expected to be returned.However, analysis of the returned device reveled a broken flush lumen.

• Brand Name: FARAWAVE PULSED FIELD ABLATION CATHETER, 35MM
• 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: 18798043
• MDR Text Key: 336547461
• Report Number: 2124215-2024-11762
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/28/2024

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: 8011304-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male