BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERRATA PRESSURE GUIDEWIRE

    MDR report key: 4020641 · Received July 30, 2014

    Report

    Report Number
    2939520-2014-00063
    Event Type
    Injury
    Date Received
    July 30, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    VOLCANO S.R.L.
    Product Code
    DQX
    PMA / PMN Number
    K131288
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. TO DATE NO OTHER COMPLAINTS WAS REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. THE DEVICE WAS RETURNED AND INVESTIGATED IN ACCORDANCE WITH VOLCANO POLICY. VISUAL AND MICROSCOPIC INSPECTIONS WERE PERFORMED AND IT WAS OBSERVED THAT THE WIRE WAS RECEIVED DAMAGED WITH AN UNBOUND AND STRETCHED FLEXIBLE COIL. THE FLEXIBLE COIL HAD UNWOUND FROM ITS COILED POSITION. THE DISTAL TIP (INCLUDING THE COREWIRE) WHICH IS APPROXIMATELY 3 CM WAS BROKEN; HOWEVER, THE PRESSURE SENSOR AND DOME WERE INTACT. THE PROXIMAL PORTION OF THE PROXIMAL CONDUCTIVE BAND (WITH LOCKING CORE) WAS ALSO BROKEN/MISSING. THE FLEXIBLE COIL DESIGN FACILITATES SHAPING AND PROVIDE A SOFT, ATRAUMATIC TIP DURING USE. OBSERVED DAMAGE CAN BE CAUSED IF THE DEVICE IS IMPACTED, MANIPULATED OR IF EXCESSIVE FORCE IS APPLIED OR THE TIP COIL BEING CAUGHT IN OTHER DEVICES MAY CAUSE THE COILS TO BE PUSHED DISTAL CREATING A GAP BETWEEN THE COILS THUS, MAY APPEAR TO HAVE UNWOUND. SINCE THE DEVICE WAS RECEIVED IN DAMAGED CONDITION, NO FUNCTIONAL TESTING WAS PERFORMED. (B)(4). A CLINICAL ASSESSMENT WAS CONDUCTED BY THE VOLCANO CORPORATION SCIENTIFIC AFFAIRS DEPARTMENT. THE RESULTS OF THE ASSESSMENT ARE SUMMARIZED BELOW: WHILE THERE WERE NO REPORTS OF PATIENT INJURY IN THIS CASE, IT WAS REPORTED THAT A DETACHED PIECE OF PRESSURE WIRE TIP WAS BRIEFLY PRESENT IN THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY. THIS FAILURE MODE IS A SAFETY CONCERN BECAUSE AN UNATTACHED GUIDE WIRE FRAGMENT HAS THE POTENTIAL TO EMBOLIZE, CAUSE LOCAL INJURY TO THE VESSEL, AND/OR INCREASE THE RISK OF THROMBUS FORMATION. IN THIS CASE, INTERVENTION WAS REQUIRED BY THE CLINICIAN TO PREVENT PATIENT HARM. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES. NO FURTHER ACTION IS REQUIRED OR ANTICIPATED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE ORIGINAL INFORMATION PROVIDED, THE VERRATA PRESSURE GUIDEWIRE WAS SHAPED IN USUAL FASHION USING THE INTRODUCER TO PROTECT THE PRESSURE SENSOR. THE WIRE WAS ZEROED AND NORMALIZED. WHEN THE WIRE WAS ADVANCED BEYOND THE LAD ARTERY LESION AND ADENOSINE INFUSION STARTED, THE WAVEFORM DISAPPEARED AND AN "ATTACH WIRE TO CONNECTOR" MESSAGE WAS DISPLAYED ON THE SYSTEM. MULTIPLE ATTEMPTS TO REGAIN THE WAVEFORM WERE UNSUCCESSFUL. THE PHYSICIAN THEN INSERTED A SECOND VERRATA THROUGH THE CATHETER WILL REMOVING THE ORIGINAL PRESSURE GUIDEWIRE. UPON REMOVAL OF THE WIRE FROM THE BODY, THE PHYSICIAN NOTED THAT THE DISTAL TIP WAS FRAYED. FFR WAS PERFORMED WITH SECOND VERRATA AND DURING ADDITIONAL FLUOROSCOPY; A WIRE TIP WAS SEEN IN THE PATIENT'S CORONARY ARTERY. THE WIRE TIP WAS CAPTURED USING LOW LEVEL BALLOON INFLATION AND WAS SUCCESSFULLY RETRACTED BACK INTO THE GUIDE CATHETER AND REMOVED FROM THE PATIENT'S BODY. THERE WAS NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445815 VERRATA PRESSURE GUIDEWIRE WIRE, GUIDE, CATHETER DQX VOLCANO S.R.L. 10185 0243 50011873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention