BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA PX SLIM DELIVERY MICROCATHETER

    MDR report key: 3090721 · Received May 2, 2013

    Report

    Report Number
    3005168196-2013-00162
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K100826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE FASTENER ON THE DISTAL END OF THE RHV IS NO LONGER ATTACHED TO THE UNIT. HOWEVER, IT CAN BE REATTACHED AND TIGHTENED DOWN TO OPERATE NORMALLY. CONCLUSION: THE COMPLAINT HAS BEEN EVALUATED AND CONFIRMED. THE COMPLAINT STATES THAT THE PHYSICIAN HAD TROUBLE INSERTING THE CATHETER THROUGH THE RHV AND THAT IN ORDER TO ADVANCE THE CATHETER, THE PHYSICIAN ATTEMPTED TO OPEN THE RHV MORE. HOWEVER, WHILE ATTEMPTING TO OPEN THE RHV MORE TO INSERT THE CATHETER THE RHV BROKE. WHEN THE PHYSICIAN ATTEMPTED TO OPEN THE RHV FURTHER, IT WAS TURNED PAST THE POINT IT WAS INTENDED TO AND THE FASTENER CAME FREE OF THE SCREW THREADS. IF A RHV IS FORCED OPEN MORE THAN IT IS DESIGNED TO, IT IS POSSIBLE FOR DAMAGE TO OCCUR TO PRODUCT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    PHYSICIAN OPENED PX SLIM 45 DEGREES TIP CATHETER IN PREPARATION FOR TREATING PATIENT WITH PULMONARY AVM. PHYSICIAN THEN TRIED TO LOAD CATHETER INTO THE ROTATING HEMOSTATIC VALVE (RHV) AND ENCOUNTERED RESISTANCE. HE THEN TWISTED THE RHV TO OPEN IT FURTHER, AND THE RHV BROKE IN HIS HANDS. HE THEN USED A DIFFERENT RHV AND THE SAME CATHETER TO COMPLETE THE CASE. THIS DID NOT CAUSE ANY PATIENT HARM AS THIS WAS RESOLVED BEFORE INSERTING CATHETER INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191200 PENUMBRA PX SLIM DELIVERY MICROCATHETER DQY DQY PENUMBRA, INC. F32654

    Patients

    Seq Age Sex Outcome Treatment
    1