BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION PV .018

    MDR report key: 3190544 · Received June 21, 2013

    Report

    Report Number
    2939520-2013-00025
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    OBJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IVUS CATHETER WAS RETURNED TO THE MFR FOR EVALUATION. THE MFR'S FACILITY IN (B)(4) CONFIRMED THAT THE DISTAL TIP WAS RETRIEVED AND RETURNED. HOWEVER, UPON RECEIPT IN THE MFR'S USA FACILITY, IT WAS OBSERVED THAT THE DISTAL TIP WAS NOT IN THE PACKAGE CONTAINING THE REMAINDER OF THE CATHETER. IT IS POSSIBLE THAT WHEN THE CONTRACTING COMPANY IN (B)(4) VERIFIED THE SERIAL NUMBER OF THE RETURNED DEVICE, THE TIP MAY HAVE DROPPED OUT FROM THE BAG. DURING EVALUATION TRACES OF ADHESIVE WERE PRESENT ON THE INNER MEMBRANE (RO TUBE) AND THE SCANNER BODY WHICH DETERMINE THAT THE DEVICE HAD THE DISTAL TIP ATTACHED BEFORE IT LEFT THE MFG FACILITY. THIS TYPE OF SEPARATION IS LIKELY THE CAUSE OF HANDLING. THE MFG DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MFG RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS FAILURE MODE WITHIN THIS LOT. THE IFU PRECAUTIONS FOR THIS DEVICE STATES: PROTECT THE CATHETER TIP FROM IMPACT AND EXCESSIVE FORCE. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED INTO A STENOSIS AREA AT PORTON PUMP INHIBITOR (PPI), BUT COULD NOT CROSS THE LESION. THE CATHETER WAS REMOVED FROM THE BODY AND IT WAS NOTICED THAT THE TIP HAD SEPARATED. THE LESION WAS APPROACHED FROM BOTH OF ANTEGRADE AND RETROGRADE AND THE SEPARATED TIP WAS OBSERVED IN THE GUIDEWIRE. THUS, THE TIP COULD BE AND WAS PUSHED OUT FROM THE BODY BY A MICRO CATHETER. IT WAS CONFIRMED THAT THE TIP WAS REMOVED FROM THE BODY. ANOTHER SAME PRODUCT WAS USED AND THE PROCEDURE WAS COMPLETED. NO PT INJURY AND NO ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282721 VISION PV .018 INTRAVASCULAR ULTRASOUND CATHETER OBJ VOLCANO CORPORATION 86700 003 02576

    Patients

    Seq Age Sex Outcome Treatment
    1