BEUDAMED
    FDA Adverse Event Death Summary report: N

    FAST-CATH HEMOSTASIS INTRODUCER, 14F, 30CM

    MDR report key: 2396744 · Received December 23, 2011

    Report

    Report Number
    2182269-2011-00202
    Event Type
    Death
    Date Received
    December 23, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS ST. JUDE MEDICAL - ATRIAL FIBRILLATION MDR # 2030404-2011-00337. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. BASED ON THE INFO PROVIDED TO ST. JUDE MEDICAL, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE FAST-CATH INTRODUCER INSTRUCTIONS FOR USE (IFU) STATES THAT UPON REMOVAL OF THE HEMOSTASIS INTRODUCER, PROPER PRECAUTIONS SHOULD BE TAKEN TO PREVENT BLEEDING. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES TO ADVANCE DILATOR/SHEATH ASSEMBLY WITH A TWISTING MOTION TO AVOID DAMAGE TO THE SHEATH OR VESSEL. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES INDIVIDUAL PT ANATOMY AND PHYSICIAN TECHNIQUE MAY REQUIRE PROCEDURAL VARIATIONS. THE FAST CATH INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER TO INSERT THE DILATOR INTO HEMOSTASIS VALVE AND THEN FOLLOW NORMAL ACCEPTED PRACTICE FOR VESSEL PUNCTURE, GUIDEWIRE INSERTION, VESSEL DILATOR AND HEMOSTASIS INTRODUCER USE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE INSERTING A 14F FAST-CATH INTRODUCER, AN ARTISAN AND COOL PATH CATHETERS, THE INFERIOR VENA CAVA WAS PERFORATED NEAR THE ILIAC BIFURCATION. THE PHYSICIAN FELT RESISTANCE WHEN INSERTING THE INTRODUCER THROUGH THE LEFT LEG AND WAS UNABLE TO PASS THE ILIAC BRANCH. THE INTRODUCER WAS PULLED BACK AND THE PHYSICIAN OBSERVED A KINK IN THE SHEATH. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE ILIAC BIFURCATION BY INSERTING THE ARTISAN CATHETER WITH THE COOL PATH ABLATION CATHETER SEATED INSIDE. THE COOL PATH CATHETER WAS EXTENDED PAST THE ARTISAN TO ASSIST WITH NAVIGATING THE VASCULATURE. THE PHYSICIAN HAD DIFFICULTY ADVANCING THE CATHETER AND FELT MORE RESISTANCE THAN EXPECTED. WHILE MANUALLY PUSHING THE CATHETER, THE PHYSICIAN PERFORATED THE INFERIOR VENA CAVA NEAR THE ILIAC BIFURCATION AND THE PT EXPERIENCED INTERNAL HEMORRHAGING. THE PERFORATION WAS DIAGNOSED WITH ULTRASOUND AND THE PT WAS SENT TO SURGERY. THE PT EXPIRED POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMOSTASIS INTRODUCER, 14F, 30CM FAST-CATH INTRODUCER DYB ST. JUDE MEDICAL NA 3445940

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death THE PATIENT WAS PRESCRIBED HEPARIN (DOSAGE UNK).