BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2PC VSYS W/9FR INTR KIT LW PFL

    MDR report key: 4848067 · Received June 16, 2015

    Report

    Report Number
    1219930-2015-00477
    Event Type
    Malfunction
    Date Received
    June 16, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 8, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    LJS
    PMA / PMN Number
    K961856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: IMPLANT. ACCORDING TO THE REPORTER: THE SURGEON USED THE SHEATH/DILATOR ASSEMBLY TO DILATE. HOWEVER, WHILE INSERTING THE ASSEMBLY INTO THE VESSEL, THE SURGEON FELT IT STUCK A LITTLE BIT. SO THE SURGEON TOOK IT OUT AND FOUND THAT THE HEAD OF THE SHEATH WAS FRACTURED. THE ISSUE WAS NOTICED DURING THE PROCEDURE. A PUNCTURE TECHNIQUE WAS USED. THERE WAS NO PATIENT INJURY. NOTHING FELL INTO THE PATIENT. THERE WAS NO TISSUE LOSS, NO BLOOD LOSS, AND NO TISSUE DAMAGE. THE SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES. 8. WHAT IS THE CURRENT STATUS OF THE PATIENT? NO INJURY. 9. CAN YOU CONFIRM THAT THE DEVICE WILL BE RETURNED FOR EVALUATION? YES. 10. WAS THE DEVICE REPROCESSED OR RE-STERILIZED PRIOR TO USE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391284 2PC VSYS W/9FR INTR KIT LW PFL CATHETER INTRODUCER KIT LJS COVIDIEN, FORMERLY US SURGICAL A DIVISON 120021 N4G0223X

    Patients

    Seq Age Sex Outcome Treatment
    1