BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1770623 · Received July 27, 2010

    Report

    Report Number
    2015691-2010-13759
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 24, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED DEFECT COULD NOT BE CONFIRMED FOR BALLOON RUPTURE. THE EVALUATION INCLUDED VISUALLY EXAMINE AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS; CONTAMINATION; OR IMPROPER LABELING. VISUALLY INSPECT THE BALLOON AND BALLOON WINDINGS/BONDS FOR INDICATION OF DAMAGE OR ABNORMALITY. THE CATHETER BALLOON AND COIL TIP WERE RECEIVED DAMAGED. THE BALLOON APPEARS TORN IN THE CENTRAL AREA OF THE LATEX, THE COIL WIRE HAS BEEN STRETCHED AND THE PROXIMAL WINDINGS AND DISTAL SECTION OF THE TORN LATEX ARE MISSING FROM THE CATHETER AND WERE NOT RETURNED. THE COIL WIRE IS NOT BROKEN, THERE IS NO MISSING WIRE. THERE IS NO EVIDENCE OF A MANUFACTURING DEFECT.

    Additional Manufacturer Narrative · 1

    CROSS REFERENCE SUBMISSION: 2015691-2010-13758.

    Description of Event or Problem · 1

    VENT ALARMING, PATIENT UP IN CHAIR, TRACH PULLED OUT, PATIENT'S FACE AND NECK ON LEFT SIDE BEGINNING TO SWELL INDICATING SUBCUTANEOUS EMPYSEMA. RAPID RESPONSE CALLED, RT REMOVED TRACH & BAG MASK, NEW TRACH PLACED. CPR INITIATED BY ACLS NURSE - PERFORMED APPROXIMATELY 30 SECONDS WHEN DEFIB PADS APPLIED - CPR STOPPED, SHOWED SINUS TACH ON MONITOR.

    Description of Event or Problem · 1

    REPORTEDLY, THE EMBOLECTOMY CATHETER RUPTURED IN THE PATIENT'S VESSEL AND THEY WERE UNABLE TO RETRIEVE THE BALLOON MATERIAL. LIKELY RETENTION OF STRIPPED OFF LATEX BALLOON MEMBRANE IN PATIENT'S PERONEAL ARTERY. NO IMMEDIATE ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120803F 58843096

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention