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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
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FARAPULSE, INC. FARAWAVE PULSED FIELD ABLATION CATHETER; CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER Back to Search Results
Lot Number 0033581223
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2024
Event Type  malfunction  
Event Description
It was reported that during a pulse field ablation (pfa) procedure a farawave pulsed field ablation catheter was selected for use.Near the end of the procedure, it was found that the guidewire lumen had detached from the tip of the catheter.The catheter was replaced and the procedure was completed.No patient complications were reported.It is unknown if the device will be returned for 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.
 
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.
 
Event Description
It was reported that during a pulse field ablation (pfa) procedure a farawave pulsed field ablation catheter was selected for use.Near the end of the procedure, it was found that the guidewire lumen had detached from the tip of the catheter.The catheter was replaced and the procedure was completed.No patient complications were reported.It is unknown if the device will be returned for analysis.
 
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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 (Section G)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19213256
MDR Text Key341390462
Report Number2124215-2024-26074
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,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? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0033581223
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received05/01/2024
Supplement Dates FDA Received05/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2024
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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