BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET

    MDR report key: 2041081 · Received March 29, 2011

    Report

    Report Number
    2522007-2011-00003
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 23, 2011
    Manufacturer
    COOK VASCULAR INC
    Product Code
    DRE
    PMA / PMN Number
    K061000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COOK (B)(6) REPORTED FOR THE CUSTOMER, "AFTER THE REMOVAL OF THE FIRST LEAD, THE RR BROKE DOWN AND THE PHYSICIANS OPENED THE CHEST. IT SHOWED A TEAR IN THE V.CAVA SUPERIOR AFTER THE USE OF LR-PPLBES-7.0 AND LR-EVN-9.0." RESPONSE FOR ADDITIONAL INFO RECEIVED: REP HAS COME BACK TO ME WITH THE FOLLOWING INFO ON (B)(4) / (B)(4). WITH REGARD TO THE INVOLVED DEVICES: "THE INVOLVED PRODUCTS WORKED AS WELL! IT'S NOT POSSIBLE TO SAY WHICH PRODUCT CAUSED THE COMPLICATION. THE OPERATION WAS A HIGH RISK OPERATION AND THE PT WAS IN A REALLY BAD CONDITION. THE TEAR IN THE V.CAVA SUPERIOR IS ALSO A WELL-KNOWN COMPLICATION SO THAT COMPLAINT IS NOT A PRODUCT COMPLAINT, IT'S A PROCEDURE COMPLICATION!" NO SECTION OF THE DEVICE HAD TO BE REMOVED FROM THE PT. ADDITIONAL PROCEDURE: THORACOTOMY TO CLOSE THE TEAR, NO ADVERSE EFFECTS ON THE PT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD EXTRACTION EVOLUTION MECHANICAL DILATOR SHEATH SET VESSEL DILATOR FOR PERCUTANEOUS CATHETERIZATION DRE COOK VASCULAR INC LR-EVN-9.0 N91149

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention