BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONS PV .018

    MDR report key: 1613659 · Received February 17, 2010

    Report

    Report Number
    2939520-2010-00007
    Event Type
    Other
    Date Received
    February 17, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 7, 2010
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K944004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DOCUMENTATION FOR THIS LOT WAS REVIEWED AND TO DATE, NO COMPLAINTS HAVE BEEN FILED AGAINST IT. MFG DOCUMENTATION WAS REVIEWED AND THERE WERE NO DEVIATIONS OR NON-CONFORMANCES THAT WOULD REASONABLY BE EXPECTED TO CONTRIBUTE TO THE REPORTED FAILURE MODE. THE COMPLAINT DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. A DEFORMATION OF THE OUTER SHAFT WAS OBSERVED AT APPROXIMATELY 3 CM FROM THE DISTAL TIP. A 0.018" MANDREL WAS INSERTED INTO THE LUMEN FROM BOTH THE DISTAL TIP AND EXIT PORT. IN BOTH INSTANCES, A BLOCKAGE WAS ENCOUNTERED AT THE LOCATION OF THE SHAFT DEFORMATION. WHEN THE MANDREL WAS REMOVED FROM THE EXIT PORT, A 3MM PLUG OF SUBSTANCE THAT APPEARS TO BE DRIED BLOOD WAS STUCK TO THE TIP OF THE MANDREL. ONCE THE OBSTRUCTION WAS REMOVED, NO RESISTANCE WAS ENCOUNTERED FROM EITHER END OF THE DEVICE. THE DESCRIPTION INDICATES THIS DEVICE NEVER ENTERED THE PT'S BODY, BUT THE OBSTRUCTION INDICATES THIS DEVICE HAD BEEN PREVIOUSLY USED. THIS CATHETER WAS UNABLE TO LOAD OVER THE GUIDE WIRE DUE TO THE PRESENCE OF A BLOOD CLOT IN THE GUIDE WIRE LUMEN. THIS EVENT IS BEING REPORTED AS A NOTIFICATION ONLY. THERE IS NO EVIDENCE FOUND TO INDICATE THIS CATHETER WAS NOT MFG TO SPECIFICATIONS NOR HAD ANY CONDITION WHICH WOULD CAUSE THIS FAILURE. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS UNABLE TO LOAD A VISIONS PV 0.018 IVUS CATHETER OVER AN ASAHI INTEC NEO'S ASTATO .018" GUIDE WIRE DURING THE OPERATION CHECK PRIOR TO INSERTION INTO THE ARTERY. TO TROUBLESHOOT, THE GUIDE WIRE LUMEN WAS FLUSHED, BUT THE CATHETER WAS UNABLE TO LOAD OVER THE WIRE. THE USER REPORTED THERE MAY BE A PROBLEM WITH THE GUIDE WIRE LUMEN. THE PHYSICIAN DECIDED NOT TO USE EITHER THE CATHETER OR THE GUIDE WIRE FOR THE REST OF PROCEDURE. THE LESION WAS REWIRED WITH A 0.014" GUIDE WIRE AND A VOLCANO EAGLE EYE GOLD IVUS CATHETER REPLACED THE VISIONS PV 0.018. THE PROCEDURE WAS COMPLETED AND NO PATIENT INJURY WAS REPORTED. THIS IS BEING REPORTED AS A NOTIFICATION ONLY. IT IS VOLCANO'S POLICY TO REPORT ALL CASES WHERE A CATHETER ISSUE CAUSES REMOVAL OR EXCHANGE OF THE GUIDE WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV .018 INTRAVASCULAR ULTRASOUND CATHETER IYO VOLCANO CORPORATION 86700 003 02335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other