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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER Back to Search Results
Lot Number 0008021427
Device Problem Positioning Failure (1158)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2023
Event Type  malfunction  
Manufacturer Narrative
The farawave pulsed field ablation catheter was returned to boston scientific for analysis.Upon receipt at the post market quality assurance laboratory the catheter underwent visual inspection, x-ray inspection, and functional testing.No outer abnormalities were observed.The device was put on the x-ray to look for any potential abnormalities that could have contributed to deployment issues, but no anomalies were noted.A guidewire was inserted through the device and an attempt was made to deploy the catheter.While moving the slider switch, the spline cage remained undeployed.It was observed that the guidewire lumen was no longer adhered to the tip of the spline cage.The device was dissected to look for any abnormalities that could have contributed to the delamination of the guidewire lumen.Nothing out of the ordinary was noted.The reported clinical observations were confirmed.
 
Event Description
It was reported that during an ablation procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.The catheter was prepared properly before insertion and was able to deploy to the basket and flower configurations and then un-deploy.After the first ablation application in the basket configuration the catheter could not be deployed to the flower configuration despite the slider moving back.The catheter was undeployed, but then could not be deployed to either configuration.The catheter was removed from the patient and examined.No resistance was felt when moving the slider and there were no problems with the guidewire.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to be returned for analysis.The farawave pulsed field ablation catheter was received and analyzed at boston scientific's post market laboratory.Upon receipt at our post market quality assurance laboratory it was found, while testing deployment, that the guidewire lumen was no longer adhered to the tip of the spline cage, resulting in the inability to deploy the catheter.
 
Manufacturer Narrative
The farawave pulsed field ablation catheter was returned to boston scientific for analysis.Upon receipt at the post market quality assurance laboratory the catheter underwent visual inspection, x-ray inspection, and functional testing.No outer abnormalities were observed.The device was put on the x-ray to look for any potential abnormalities that could have contributed to deployment issues, but no anomalies were noted.A guidewire was inserted through the device and an attempt was made to deploy the catheter.While moving the slider switch, the spline cage remained undeployed.It was observed that the guidewire lumen was no longer adhered to the tip of the spline cage.The device was dissected to look for any abnormalities that could have contributed to the delamination of the guidewire lumen.Nothing out of the ordinary was noted.The reported clinical observations were confirmed.
 
Event Description
Clinical study name: faradise, clinical study id: (b)(6).It was reported that the catheter could not be deployed properly after preparation.During an ablation procedure to treat atrial fibrillation a farawave pulsed field ablation catheter was selected for use.The catheter was prepared properly before insertion and was able to deploy to the basket and flower configurations and then un-deploy.After the first ablation application in the basket configuration the catheter could not be deployed to the flower configuration despite the slider moving back.The catheter was undeployed, but then could not be deployed to either configuration.The catheter was removed from the patient and examined.No resistance was felt when moving the slider and there were no problems with the guidewire.The catheter was replaced and the procedure was completed successfully.No patient complications were reported.The farawave pulsed field ablation catheter was received and analyzed at boston scientific's post market laboratory.Upon receipt at our post market quality assurance laboratory it was found, while testing deployment, that the guidewire lumen was no longer adhered to the tip of the spline cage, resulting in the inability to deploy the catheter.
 
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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 Key18861829
MDR Text Key337183927
Report Number2124215-2024-10470
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeGR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/26/2024
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 Number0008021427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/19/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2024
Initial Date FDA Received03/07/2024
Supplement Dates Manufacturer Received04/06/2024
Supplement Dates FDA Received04/26/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age37 YR
Patient SexMale
Patient Weight97 KG
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