BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULLINS TRANSSIPTAL SHEATH

    MDR report key: 4716 · Received July 31, 1992

    Report

    Report Number
    4716
    Event Type
    Malfunction
    Date Received
    July 31, 1992
    Date of Event
    June 24, 1992
    Report Date
    July 31, 1992
    Manufacturer
    UNKNOWN
    Product Code
    EYT
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO ADVANCE CATHETER THROUGH THE SHEATH, THE SHEATH WAS NOTED TO BE KINKED SIGNIFICANTLY ENOUGH TO PREVENT PASSAGE. THE SHEATH WAS REMOVED WITHOUT ANY COMPLICATIINS. DEVICE WAS NOT SAVEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULLINS TRANSSIPTAL SHEATH USCF INTRODUCER EYT UNKNOWN 540122

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other