BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2200895 · Received August 11, 2011

    Report

    Report Number
    9673241-2011-00085
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P990025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATHETER WAS TESTED AND PASSED DEFLECTION, ELECTRICAL, LEAKAGE, TEMPERATURE AND GENERATOR TESTS. CATHETER APPEARS IN GOOD CONDITION. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. COMPLAINT CONDITION CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT DEVICES: STOCKERT, US CATALOG # S7001, (B)(4); CARTO XP, US CATALOG # M470001, (B)(4). THE CUSTOMER CONFIRMED THAT THEY DO NOT CONSIDER THE BWI EQUIPMENT OR PRODUCTS TO BE THE CAUSE OF THE PATIENT INCIDENT. THE CUSTOMER DECLINED TO HAVE THE BWI EQUIPMENT FUNCTIONAL TESTED. (B)(4). THE CATHETER WAS TESTED AND PASSED DEFLECTION, ELECTRICAL, LEAKAGE, TEMPERATURE AND GENERATOR TESTS. CATHETER APPEARS IN GOOD CONDITION. THE DEVICE HISTORY RECORD WAS REVIEWED. NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES COMPLAINT CONDITION CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A STROKE DURING A LEFT SIDED IDIOPATHIC VT ABLATION. THE PHYSICIAN HAD MAPPED THE LEFT VENTRICLE USING A NAVISTAR CATHETER WITH CARTO XP AND HAD APPLIED THE FIFTH RF LESION WHEN THE PATIENT COMPLAINED OF PARTIAL VISION LOSS IN HER RIGHT EYE. AT THE TIME OF THE EVENT THE ACT WAS 260. THE PHYSICIAN REMOVED THE CATHETERS AND HAD THE LAB STAFF ADMINISTER A BOLUS OF HEPARIN. PATIENT VS WERE STABLE AND A NEURO CHECK WAS PERFORMED ON THE PATIENT. THE PATIENT HAD NO OTHER NEURO DEFICITS AND WAS ABLE TO MOVE ALL EXTREMITIES. THE PATIENT WAS SENT FOR A CT SCAN AND PRIOR TO LEAVING STATED HER VISION HAD RETURNED TO NORMAL. THE BWI PRODUCTS USED IN THE PROCEDURE INCLUDED THE CARTO XP, STOCKERT, AND A NAVISTAR CATHETER. THE CATHETER HAS BEEN SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1183-08-S 15328268M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R