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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 0008021497
Device Problems Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/20/2024
Event Type  malfunction  
Event Description
It was reported that during a procedure a farawave pulsed field ablation catheter was selected for use.When preparing the catheter, a white powder was noticed on the handle.The physician decided to clean the catheter and use it.After successfully ablating the left pulmonary vein, the physician moved to the right inferior pulmonary vein and when tried to deploy the catheter a spline inversion occurred.Manual troubleshooting did not solve the issue, so the catheter was replaced.The procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
 
Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
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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 Key18970025
MDR Text Key338550095
Report Number2124215-2024-17521
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/25/2024
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 Number0008021497
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received03/25/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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