BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 3070236 · Received April 1, 2013

    Report

    Report Number
    1820334-2013-00166
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 14, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AORTIC VALVULOPLASTY PERFORMED WITHOUT COMPLICATION. WHEN THE 10FR SHEATH WAS REMOVED FROM THE PATIENT, THE PHYSICIAN NOTICED THAT THE LENGTH OF THE SHEATH WAS SIGNIFICANTLY SHORTER THAN WHEN IT WAS FIRST INSERTED. THEY OPENED ANOTHER SHEATH AND COMPARED LENGTHS AND CONFIRMED IT WAS SHORTER. THEY FEARED THAT THE TIP OF THE SHEATH HAD BROKEN OFF AND WAS STILL IN THE PATIENT. CT SCANS OF THE PATIENT CONFIRMED THAT THERE WAS NOTHING LEFT BEHIND. ADDITIONAL INFORMATION PROVIDED BY THE REP ON 02/25/2013: ONCE I ( THE REP) COLLECTED THE SHEATH AND INSPECTED IT, I (THE REP) CAN SEE THAT THE TIP HAS NOT BROKEN OFF. EVEN THOUGH IT IS DAMAGED DUE TO THE BALLOON BEING PULLED THROUGH IT... IT LOOKS INTACT TO ME (THE REP). NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT REQUIRED A CT SCAN TO CONFIRM THAT NO PART OF THE DEVICE REMAINED INSIDE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133816 PERFORMER INTRODUCER DYB COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK