BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEWIRE

    MDR report key: 1497972 · Received September 3, 2009

    Report

    Report Number
    2939520-2009-00025
    Event Type
    Malfunction
    Date Received
    September 3, 2009
    Date of Event
    July 14, 2009
    Report Date
    September 4, 2009
    Manufacturer
    VOLCANO CORP
    Product Code
    DXO
    PMA / PMN Number
    K070487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE, VISUAL AND PERFORMANCE TESTS WERE CONDUCTED. PERFORMANCE TESTING WAS CONDUCTED AND THE ERROR COULD NOT BE REPLICATED. DURING VISUAL INSPECTION, IT WAS NOTED THE DEVICE WAS RECEIVED IN ITS ORIGINAL PACKAGING INSIDE THE PROTECTIVE COIL IN DAMAGED CONDITION. THE HYPOTUBE WAS KINKED AT 7.5 CM DISTAL TO THE CONNECTOR END OF THE WIRE. THE SENSOR HOUSING WAS INSPECTED AND FOUND FREE OF ANY DAMAGE OR FOREIGN DEBRIS. THE RADIOPAQUE COIL WAS STRETCHED NEAR THE SENSOR HOUSING. THE DOME AT THE DISTAL TIP WAS FOUND MISSING AND CORROSION WAS OBSERVED ON THE SCREW TIP. DUE TO THE MISSING DOME THE CUSTOMER WAS CONTACTED TO INVESTIGATE IF THE MISSING PORTION WAS A RESULT OF HANDLING OR IF THE DOME COULD HAVE DISLODGED DURING THE PROCEDURE. DURING FURTHER INVESTIGATION, THE CUSTOMER STATED "WHEN WE OPENED THE PRESSURE WIRE AND CONNECTED IT TO THE SMARTMAP BOX, IT DISPLAYED AN ERROR. AT THAT POINT, WE DECIDED TO TRY OPENING A NEW WIRE (WHICH DID WORK AS INTENDED). THE WIRE IN QUESTION WAS NEVER REMOVED FROM THE HOOP IT IS PACKAGED IN, AND CERTAINLY NEVER WENT IN THE BODY." DUE TO DECONTAMINATION PROCEDURES VISUAL INSPECTION OF THE DEVICE COULD NOT CONCLUDE IF THE DEVICE WAS USED IN A PATIENT. SIMILAR DAMAGE MAY OCCUR DURING SHIPPING AND HANDLING OF THE DEVICE OUTSIDE THE PROTECTIVE COIL PACKAGING. THIS PRODUCT WAS RETURNED IN A PROTECTIVE COIL, POUCH, AND BOX, LEAVING THE KINK AND STRETCHED RADIOPAQUE COIL DAMAGE UNEXPLAINED. ALTHOUGH THE HOSPITAL CONFIRMED THERE WAS NO PATIENT IMPACT DUE TO THIS INCIDENT AND THE DOME IS RADIOPAQUE AND WOULD BE VISUALIZED IF DISLODGED IN A PATIENT, A PORTION OF THE DEVICE IS UNACCOUNTED FOR, THEREFORE, THERE IS A POTENTIAL FOR INJURY SHOULD THIS HAPPEN AGAIN. THIS REPORT IS BEING SENT AS A NOTIFICATION. (B) (4).

    Description of Event or Problem · 1

    PRESSURE WIRE HAD A "SHORT CONDITION" PRESSURE WIRE WAVEFORM WOULD INTERMITTENTLY GO AWAY, THEN COME BACK ON. ANOTHER WIRE WAS PULLED AND WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEWIRE TRANSDUCER, PRESSURE, CATHETER TIP DXO VOLCANO CORP 7903 120-01562

    Patients

    Seq Age Sex Outcome Treatment
    1 Other