BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM

    MDR report key: 1991031 · Received February 10, 2011

    Report

    Report Number
    3005188751-2011-00013
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPOT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PERFORMING AN ABLATION PROCEDURE, THE INTRODUCER WAS PREPARED AND THE TRANSSEPTAL PUNCTURE WAS PERFORMED. THE INTRODUCER AND ELECTROPHYSIOLOGY CATHETER WERE PLACED IN THE LEFT ATRIUM. THE PHYSICIAN THEN NOTED THAT THE PT HAD ST SEGMENT ELEVATION ON THE EKG INDICATIVE OF "ISCHEMIA OF THE INFERIOR WALL OF THE LEFT VENTRICLE." THE PHYSICIAN ATTEMPTED TO ASPIRATE THE SHEATH VIA THE HEMOSTASIS VALVE AND AIR WAS ASPIRATED INTO THE SHEATH. THE CATHETER AND THE SHEATH WERE REMOVED FROM THE PT. THE PT THEN WENT INTO VENTRICULAR FIBRILLATION AND REQUIRED RESUSCITATION. THE PT STABILIZED AND HAS RECOVERED FULLY WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ 8.5F BRAIDED TRANS INTRODUCER, SL0, 63CM SWARTZ 8.5F, INTRO, SL0 DYB ST. JUDE MEDICAL, AF DIVISION 407451 3239248

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other CATHETER| BARD DYNAMIC DECA STEERABLE DIAGNOSTIC CATHETER| BIOSENSE WEBSTER LASSO STEERABLE DIAGNOSTIC