BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK .035 STENT DELIVERY SYSTEM

    MDR report key: 1203211 · Received October 17, 2008

    Report

    Report Number
    3004742046-2008-00253
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K053459
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH THE STENT IMPLANT STATIONARY ON THE BALLOON AND BETWEEN THE MARKERS. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT, THE SDS OR THE TIGHTLY FOLDED BALLOON. IT WAS NOTED THAT THE PROXIMAL BALLOON SHOULDER WAS PARTIALLY INFLATED. USING AN INDEFLATOR, THE BALLOON WAS INFLATED AND THE STENT WAS DEPLOYED AT 4ATMS. WATER LEAKED OUT OF THE STRAIGHT PORT OF THE SIDE ARM DUE TO DELAMINATION (3CM) OF THE GLUE. A LEAK WAS OBSERVED BETWEEN THE INFLATION LUMEN AND THE GUIDE WIRE LUMEN. NO PINHOLE WAS NOTED IN THE BALLOON AS REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    TYPE OF MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE STENT WAS READY TO BE DEPLOYED, AND THE BALLOON WAS INFLATED TO 2-3 ATM, IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. REPORTEDLY, THE HOLE MAY HAVE BEEN PRESENT BEFORE INSERTION AND NOT CAUSED BY THE PATIENT'S ANATOMY. THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITH THE STENT INTACT ON THE BALLOON. A SECOND DEVICE WAS SUCCESSFULLY USED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. ALTHOUGH REQUESTED, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK .035 STENT DELIVERY SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 8022651

    Patients

    Seq Age Sex Outcome Treatment
    1