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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 0032737721
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2024
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 for a pulmonary vein isolation de novo, the operating room (or) staff reported issues with the flushing port of the farawave catheter.Flushing through the port was not possible.They changed the catheter and finished the procedure without any additional issues.No patient complications occurred.The device is expected to be returned.
 
Event Description
It was reported that a farawave catheter during procedure for a pulmonary vein isolation de novo, some issues occurred with the flushing port.The flushing through the port was not possible, causing difficult to irrigate.They changed the catheter and finished the procedure without any additional issues or harming the patient.The device is expected to be returned.It was further reported that there was no damage to the luer, nothing was broken or detached.No leak from the catheter.No difficulty deploying or un-deploying the catheter.
 
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 a farawave catheter during procedure for a pulmonary vein isolation de novo, some issues occurred with the flushing port.The flushing through the port was not possible, causing difficult to irrigate.They changed the catheter and finished the procedure without any additional issues or harming the patient.The device is expected to be returned.It was further reported that there was no damage to the luer, nothing was broken or detached.No leak from the catheter.No difficulty deploying or un-deploying the catheter.
 
Manufacturer Narrative
Initial reporter phone: (b)(6).Upon device return and inspection a guidewire was inserted through the catheter.The catheter was deployed to basket and flower successfully.Subsequently, flushing of the device through the irrigation line was tested.Flushing was not functional in any deployment state.The catheter was dissected to inspect the flush lumen to determine any potential cause for the flushing issue.Dissection revealed some kinking of the flush lumen, which likely caused the difficulties with flushing the device.Additionally, an excess of flush lumen was noted.
 
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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 Key18979991
MDR Text Key338619018
Report Number2124215-2024-18222
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/19/2024
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 Number0032737721
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/20/2024
Initial Date FDA Received03/26/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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