BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS

    MDR report key: 9138 · Received October 24, 1994

    Report

    Report Number
    9138
    Event Type
    Injury
    Date Received
    October 24, 1994
    Date of Event
    February 4, 1994
    Report Date
    October 24, 1994
    Manufacturer
    CORDIS, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING PTCA, A 7 FR PTCA SHEATH AND INTRODUCER WAS PLACED IN R GEMORAL ARTERIAL GRAPH ABOVE AND AFTER A 7F STANDARD SHEATH AND INTRODUCER WAS PLACED IN THE NATIVE R FEMORAL ARTERY. IT APPEARS THE NATIVE R FEMORAL ARTERY SHEATH WAS PARTICALLY SHEARED OFF DURING THE INSERTION OF THE R FEMORAL ARTERY GRAFT SHEATH. WHEN THE R FEMORAL ARTERY SHEATH WAS BEING REMOVED, THE DISTAL PORTION REMAINED INTERNALLY. THE PT WAS IMMEDIATELY TAKEN TO SURGERY FOR REMOVAL OF THE DISTAL PORTION OF THE SHEATH.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INCORRECT TECHNIQUE/PROCEDURE, CAUSED BY ANOTHER DRUG/DEVICE, PORT. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS PLUS SHEATH INTRODUCER SYSTEM DYB CORDIS, INC. 7 F PLUS 10 CM .38 IN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention