BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO

    MDR report key: 2121062 · Received June 9, 2011

    Report

    Report Number
    3005188751-2011-00084
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNK. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH OPERATIONAL CONTEXT AS THE REPORTED EVENT IS DUE TO ANATOMICAL/PROCEDURAL FACTORS.

    Description of Event or Problem · 1

    SAME AS MFR REPORT #3005188751-2011-00083. IT WAS REPORTED FOLLOWING TRANSSEPTAL PUNCTURE DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PT EXPERIENCED VENTRICULAR TACHYCARDIA AND ISCHEMIA DUE TO THROMBUS DISLODGEMENT AND HAD TO BE RESUSCITATED. THE PT'S BLOOD PRESSURE DROPPED SUDDENLY FOLLOWING THE TRANSSEPTAL PUNCTURE. THE PT EXPERIENCED SEVERAL EPISODES OF VENTRICULAR TACHYCARDIA WHICH REQUIRED RESUSCITATION. ACCORDING TO THE PHYSICIAN, THE CAUSE FOR THE EVENT WAS AN ISCHEMIC ACCIDENT THAT OCCURRED FROM THROMBUS DISLODGEMENT IN THE LEFT ATRIUM WHICH TRAVELED TO AND LODGED IN THE CORONARY ARTERY. ADD'L INFO WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO SWARTZ BRAIDED INTRODUCER DYB ST. JUDE MEDICAL, AF DIVISION 407449 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BRK NEEDLE: REORDER (B)(4), LOT UNKNOWN