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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
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pericardial Effusion (3271)
Event Date 03/06/2024
Event Type  Injury  
Event Description
It was reported that after a pulmonary vein isolation procedure, a farawave catheter was selected for use, however, where the patient's catheter was being maneuvered improperly without the catheter being advanced over the wire, despite the procedure being completed successfully, two hours later patient had a hemodynamic compromise and had to be taken to surgery to drain a large paracardial effusion.It is unknown if the device will return for laboratory analysis the product even after product return attempts.
 
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
Type of Device
CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER
Manufacturer (Section D)
FARAPULSE, INC.
3715 haven avenue
suite 110
menlo park CA 94025
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19011684
MDR Text Key339016699
Report Number2124215-2024-19141
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/01/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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