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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 0032535572
Device Problems Positioning Failure (1158); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
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 procedure to treat paroxysmal atrial fibrillation de novo a farawave pulsed field ablation catheter was selected for use.When the catheter was being positioned in the right superior pulmonary vein (rspv) the slider handle reached the end of its track when deploying the array and a loud click was heard.Afterwards it was not possible to change the configuration of the catheter.The catheter was removed from the patient and it was noticed the guidewire lumen was no longer attached to the distal tip of the catheter.The procedure was completed with no patient complications.The device is expected to be returned for analysis.
 
Event Description
It was reported that during a procedure to treat paroxysmal atrial fibrillation de novo a farawave pulsed field ablation catheter was selected for use.When the catheter was being positioned in the right superior pulmonary vein (rspv) the slider handle reached the end of its track when deploying the array and a loud click was heard.Afterwards it was not possible to change the configuration of the catheter.The catheter was removed from the patient and it was noticed the guidewire lumen was no longer attached to the distal tip of the catheter.The procedure was completed with no patient complications.The device is expected to be returned for analysis.It was further reported that the catheter configuration transitioning from the basket to the flower shapes is when the detachment occurred.The was no difficulty withdrawing the catheter.
 
Manufacturer Narrative
Correction to the initial mdr as the initial reporter became aware of the event on 26-march-2024 as opposed to 28-march-2024 that was previously reported.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)
BOSTON SCIENTIFIC CORPORATION
302 parkway, global park
la aurora - heredia
CS  
Manufacturer Contact
timothy degroot degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19140316
MDR Text Key340625144
Report Number2124215-2024-23743
Device Sequence Number1
Product Code QZI
Combination Product (y/n)N
Reporter Country CodeIT
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 Number0032535572
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/28/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received05/02/2024
Supplement Dates FDA Received05/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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