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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
Device Problems Leak/Splash (1354); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
It was reported that during an atrial fibrillation procedure a faradrive steerable sheath clear was selected for use.When the physician was suctioning for possible air bubbles, a lot of bubbles were observed in the sheath tubing.The seal in the hemostatic valve was not right.The device was replaced and the procedure was completed successfully.No patient complications were reported.The device is expected to return for laboratory analysis.
 
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
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 84119
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key18957045
MDR Text Key338316181
Report Number2124215-2024-15049
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
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 03/22/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/08/2024
Initial Date FDA Received03/22/2024
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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