BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2792190 · Received October 11, 2012

    Report

    Report Number
    3005188751-2012-00278
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    January 1, 2011
    Report Date
    September 14, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PROCEDURE WAS STATED AS BEING AT THE END OF 2011. WE ARE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. A DHR COULD NOT BE DONE AS THE LOT NUMBER WAS NOT PROVIDED. THE MOST LIKELY ROOT CAUSE CLASSIFICATION OF THE REPORTED EVENT IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE USING A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER A CARDIAC PERFORATION AND A RIGHT ARTERIAL TO AORTA FISTULA OCCURRED. THE PT WAS GIVEN GENERAL ANESTHESIA FOR THE PROCEDURE. THE PHYSICIAN PLACED THREE SHEATHS IN THE RIGHT FEMORAL VEIN. A DECAPOLAR CATHETER WAS PLACED INTO THE CS. A SWARTZ BRAIDED TRANSEPTAL INTRODUCER WAS USED TO INTRODUCE A TRANSSEPTAL NEEDLE AND A TRANSSEPTAL PUNCTURE WAS ATTEMPTED. RAO VIEW ON FLUOROSCOPY SHOWED THE NEEDLE A LITTLE ANTERIOR. UPON ADVANCING THE NEEDLE, THE NEEDLE AND THE JUMPED FORWARD BRIGHT RED BLOOD WAS ASPIRATED FROM THE NEEDLE. DYE WAS INJECTED AND SPREAD IN USUAL PATTERN. PRESSURE INITIALLY WAS 70 WITH SUBSEQUENT PRESSURE OF 19. THE NEEDLE WAS WITHDRAWN AND A GUIDEWIRE WAS INTRODUCED INTO THE INTRODUCER AND DILATOR WHICH THEN WENT INFEROLATERALLY WITH PVC'S NOTED. THE PHYSICIAN WAS NOT ABLE TO REDIRECT TO A LEFT SUPEROLATERAL FASHION AS USUAL WITH HIS LEFT ATRIAL PUNCTURE. HE THOUGHT HE WAS IN A GOOD POSITION IN THE RSPV IN LOOKING AT THE PREOPERATIVE CT SCAN. THE INTRODUCER WAS ADVANCED OVER THE GUIDEWIRE AND THE DILATOR AND WIRE WERE REMOVED. A D CURVE NAVISTAR CATHETER WAS PLACED THROUGH THE INTRODUCER WAS ATTACHED TO THE INTRODUCER WHICH REVEALED AO PRESSURE. AORTOGRAM CONFIRMED THE INTRODUCER WAS WITHIN THE AORTA. A RIGHT ATRIAL TO AORTA FISTULA WAS NOTED AND WAS CLOSED IN THE CATHLAB PROCEDURE ROOM WITH AN AMPLATZER DEVICE. THERE WERE NO FURTHER ADVERSE CONSEQUENCES AND THE PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANS. GUIDING INT., 8F, LAMP TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, AF DIVISION 407360

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention