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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER CARTO VIZIGO BIDIRECTIONAL GUIDE INTRODUCER, CATHETER

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BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER CARTO VIZIGO BIDIRECTIONAL GUIDE INTRODUCER, CATHETER Back to Search Results
Model Number 453054045-D138503
Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 10/27/2020
Event Type  malfunction  
Event Description
Upon removing the dilator of the sheath the rear hemostatic valve dislodged from the main sheath. This dislodgement resulted in an open blood flow from the patient's blood vessel. The hemostatic valve was intending to remain in contact with the main sheath and prevent bleed back from the patient's blood vessel. The physician immediately noticed the valve was defected and the sheath was removed from the patient. Fda safety report id# (b)(4).
 
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Brand NameBIOSENSE WEBSTER CARTO VIZIGO BIDIRECTIONAL GUIDE
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER, INC.
MDR Report Key10884683
MDR Text Key217949167
Report NumberMW5098015
Device Sequence Number1
Product Code DYB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number453054045-D138503
Device Lot Number00001085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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