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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE
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FARAPULSE, INC. FARADRIVE STEERABLE SHEATH CLEAR; VASCULAR GUIDE-CATHETER, SINGLE-USE Back to Search Results
Lot Number CL12292
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2024
Event Type  malfunction  
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.
 
Event Description
It was reported that during a pulsed field ablation procedure ablation procedure using a faradrive sheath air was drawn in from the outside.They exchanged the sheath, and the issue was resolved.The procedure was then completed with no patient complications.It is not currently known if the sheath will be returned for analysis.
 
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Brand Name
FARADRIVE STEERABLE SHEATH CLEAR
Type of Device
VASCULAR GUIDE-CATHETER, SINGLE-USE
Manufacturer (Section D)
FARAPULSE, INC.
3715 haven avenue
suite 110
menlo park CA 94025
Manufacturer (Section G)
CENTERPOINT SYSTEMS
3338 parkway blvd
west valley city UT 84119
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key19139663
MDR Text Key340623720
Report Number2124215-2024-23552
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodePL
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 04/18/2024
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 NumberCL12292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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