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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Vomiting (2144)
Event Date 02/01/2024
Event Type  Injury  
Event Description
It was reported that during an irreversible electroporation ablation procedure using a farawave catheter the patient became hypotonic and bradycardic after vomiting.The patient vomited during the procedure, so a bronchoscopy was performed to ensure the vomited had not been aspirated.During the bronchoscopy the patient became "very hypotonic and bradycardic" so cpr was performed even though the patient did not flatline.It was noted the patient looked "very puffed up" when their covering was removed for resuscitation.Once the patient had sufficient rhythm without assistance they were intubated.A ct scan was performed and then the patient was moved to the intensive care unit for recovery.The ablation procedure was not completed, and no further complications have been reported.The catheter is not expected to be returned as it was disposed of by the hospital.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, 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
CA  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18679947
MDR Text Key335070436
Report Number2124215-2024-07565
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeGM
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 02/09/2024
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 02/01/2024
Initial Date FDA Received02/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Hospitalization; Life Threatening;
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