BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSURE GUIDE WIRE

    MDR report key: 6024621 · Received October 12, 2016

    Report

    Report Number
    2939520-2016-00074
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 13, 2016
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURERS POLICY. ADDITIONAL INFORMATION: PER THE STENT MANUFACTURERS OPERATIONAL INSTRUCTIONS: "NOTE: IF UNUSUAL RESISTANCE IS FELT AT ANY TIME DURING LESION ACCESS BEFORE STENT IMPLANTATION, THE STENT DELIVERY SYSTEM AND THE GUIDE CATHETER SHOULD BE REMOVED AS A SINGLE UNIT." THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE, NO OTHER COMPLAINTS WERE REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER WAS ATTEMPTING TO DELIVER A STENT OVER THE MANUFACTURER'S WIRE WHEN THE UN-DEPLOYED STENT BECAME STUCK RESULTING IN THE MANUFACTURER'S WIRE AND THE STENT BEING REMOVED FROM THE PATIENT AS A SYSTEM. THE DEVICE WAS RETURNED AND EVALUATED IN ACCORDANCE WITH THE MANUFACTURERS POLICY. VISUAL AND MICROSCOPIC INSPECTION WERE PERFORMED ON THE RETURNED DEVICE. THE STENT WAS OBSERVED TO BE STUCK AT APPROXIMATELY 283MM FROM THE DISTAL TIP. THE PORTION OF THE STENT STUNK ON THE WIRE WAS MEASURED, A LENGTH OF 245MM WAS OBSERVED. THE DISTAL END OF THE STENT WAS OBSERVED TO BE TUCKED INTO ITSELF. KINKS AND BUNCHING WERE OBSERVED AT MULTIPLE LOCATIONS ON THE PROXIMAL COIL. THE BALLOON WAS CUT IN-BETWEEN THE UN-DEPLOYED STENT AND THE DISTAL TIP OF THE STENT DEVICE. MICROSCOPIC INSPECTION REVEALED THAT THE PROXIMAL PORTION OF THE PROXIMAL COIL WAS COVERED IN SANGUINEOUS MATERIAL BUT WAS IN GOOD CONDITION. THE DISTAL HYPOTUBE JOINT WAS DAMAGED, MOST PROBABLY FROM CUTTING THE BALLOON DURING INSPECTION; CUTS WERE OBSERVED IN THE SANGUINEOUS MATERIAL. IT WAS DIFFICULT TO REMOVE THE DISTAL TIP OF THE STENT AWAY FROM THE PROXIMAL COIL OF THE GUIDEWIRE. THREE ATTEMPTS WERE MADE BEFORE THE TIP OF THE STENT WAS SUCCESSFULLY REMOVED. THE UNCOVERED PORTION OF THE PROXIMAL COIL WAS COVERED WITH SANGUINEOUS MATERIAL. THE SANGUINEOUS MATERIAL WAS CLEANED OFF AND SLIGHT BUNCHING WAS OBSERVED IN THE PROXIMAL COIL. THE PROBABLE CAUSE OF THE OBSERVED STUCK STENT FAILURE IS MOST LIKELY THE DISTAL TIP OF THE STENT BEING TUCKED INTO ITSELF AND GETTING CAUGHT IN THE PROXIMAL COIL. HOWEVER, WE WERE UNABLE TO CONFIRM WHEN AND HOW THE FAILURE OCCURRED. THE OBSERVED KINKS AND BUNCHING OF THE PROXIMAL COIL WERE OBSERVED DISTAL TO THE STENT DEVICE. SOME SLIGHT BUNCHING WAS OBSERVED DIRECTLY UNDER THE DISTAL TIP OF THE STENT DEVICE. NO KINKS OR BUNCHING OF THE PROXIMAL COIL WERE OBSERVED PROXIMAL TO THE TIP OF THE STENT DEVICE. THE OBSERVED DAMAGED TO THE DISTAL HYPOTUBE JOINT MOST LIKELY OCCURRED DUE TO THE REMOVAL OF THE STENT FROM THE GUIDEWIRE DURING INVESTIGATION. THE PHYSICIAN UTILIZED ANOTHER OF THE MANUFACTURE'S WIRES AND A NEW STENT TO COMPLETE THE INTERVENTION WITH NO HARM TO THE PATIENT. THE PATIENT WAS RELEASED AS EXPECTED IN STABLE CONDITION. THE PATIENTS VESSEL IS REPORTED: AS MID LAD 50% FOCAL STENOSIS, NO CALCIFICATION, NOT TORTUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674545 VERRATA PRESSURE GUIDE WIRE WIRE, GUIDE, CATHETER DQX VOLCANO CORPORATION 10185 0243 50074375

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR