BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOLPATH CATHETER

    MDR report key: 2385970 · Received December 16, 2011

    Report

    Report Number
    2030404-2011-00337
    Event Type
    Death
    Date Received
    December 16, 2011
    Date of Event
    November 22, 2011
    Report Date
    December 13, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION. WE WERE UNABLE TO EVALUATE THE PRODUCT INVOLVED IN THIS INCIDENT SINCE NO COMPONENTS OF THE DEVICE WERE RETURNED FOR ANALYSIS. BASED ON THE INFORMATION PROVIDED TO ST. JUDE MEDICAL, THE CAUSE FOR THE REPORTED EVENT REMAINS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE. PERFORATION OR DAMAGE TO THE VASCULAR SYSTEM IS A KNOWN COMPLICATION AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    THIS IS THE SAME EVENT AS MFR REPORT 2182269-2011-00202. IT WAS REPORTED WHILE INSERTING A 14 FR INTRODUCER, THE EARTISAN AND COOL PATH CATHETER, THE INFERIOR VENA CAVA WAS PERFORATED NEAR THE ILIAC BIFURCATION. THE PHYSICIAN FELT RESISTANCE WHEN INSERTING THE 14F 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 INTRODUCER. THE PHYSICIAN THEN ATTEMPTED TO CROSS THE ILIAC BIFURCATION BY INSERTING THE EARTISAN CATHETER WITH THE COOL PATH ABLATION CATHETER SEATED INSIDE. THE COOL PATH CATHETER WAS EXTENDED PAST THE EARTISAN 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. THE PERFORATION WAS DIAGNOSED WITH ULTRASOUND AND THE PATIENT WAS SENT TO SURGERY WHERE THE PERFORATION WAS CONFIRMED. THE PATIENT EXPIRED POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLPATH CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83562 K17320

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death EARTISAN CATHETER: MODEL 04453-0001, LOT 20110801| MODEL 407449, LOT UNKNOWN| 14F INTRODUCER: 406188, LOT NUMBER 3445940| SWARTZ BRAIDED TRANS. GUIDING INTRODUCER 8F