BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS AVANTI CATHETER SHEATH

    MDR report key: 170908 · Received June 4, 1998

    Report

    Report Number
    1016427-1998-00263
    Event Type
    Injury
    Date Received
    June 4, 1998
    Date of Event
    May 5, 1998
    Report Date
    June 4, 1998
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT THAT CO RECEIVED INDICATED THAT 70 YEAR OLD FEMALE PT WAS ADMITTED TO EMERGENCY ROOM WITH DIAGNOSIS OF COMPLETE HEART BLOCK AND MI. PT WAS STABILIZED WITH DRIPS AND TEMPORARY PACER. RIGHT SUBCLAVIAN PUNCTURE WAS MADE FOR INSERTION OF CSI PRIOR TO TRANSPORT OF PT TO CATH LAB FOR PERMANENT PACEMAKER. CSI WAS INTRODUCED WITHOUT DIFFICULTY. GUIDEWIRE AND DILATOR WERE WITHDRAWN AND GOOD FLOW WAS OBSERVED. DURING ATTEMPTS TO SUTURE THE CSI IN PLACE, THE HUB 'POPPED OFF', AS THE SUTURE WAS BY THE PHYSICIAN LOOPED AROUND THE HUB. FINGER PRESSURE AT THE SITE WAS USED UNTIL HEMOSTAT WAS OBTAINED FROM THE SUTURE KIT. PROXIMAL END OF CANNULA WAS GRABBED WITH HEMOSTAT AND CANNULA CRUMBLED. ANOTHER ATTEMPT WAS MADE WITH THE HEMOSTAT AND THE UNIT FURTHER FRACTURED. DISTAL PORTION OF CANNULA THEN "FLOATED" AWAY AND LOGED WITHIN PULMONARY ARTERY. PT WAS SENT TO CATH LAB WHERE PERMANENT PACER WAS IMPLANTED, AND SHE WAS THEN TRANSFERRED TO O.R. FOR CABG, AT WHICH TIME CANNULA FRAGMENT WAS RETRIEVED. PT'S CONDITION WAS REPORTED AS SATISFACTORY WITH NO REPORT OF OTHER INJURIES OR COMPLICATIONS. ACCORDING TO OUR CONVERSATION WITH DR., HE WAS UNAWARE OF STORAGE REQUIREMENTS FOR THESE DEVICES UNTIL AFTER EVENT. PHYSICIAN REPORTED THAT HE AND ANOTHER PHYSICIAN OPENED SECOND CSI FROM CART AND OBSERVED CRACKING, BUT NOT CRUMBLING WHEN IT WAS FLEXED. THEY THEN READ STORAGE INSTRUCTIONS AND NOTED NEED FOR COOL, DRY AND DARK ENVIRONMENT.

    Description of Event or Problem · 1

    EVENT OR PROBLEM: TIP FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS AVANTI CATHETER SHEATH CATHETER SHEATH INTRODUCER DYB CORDIS CORPORATION NA L0397742

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR