BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERRATA PRESSUR GUIDEWIRE

    MDR report key: 4200269 · Received October 22, 2014

    Report

    Report Number
    2939520-2014-00088
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 26, 2014
    Manufacturer
    VOLCARICA S.R.L.
    Product Code
    OBJ
    PMA / PMN Number
    K131288
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. THE DATE , NO OTHER COMPLAINTS WAS REPORTED FOR THIS SAME FAILURE MODE WITHIN THIS LOT. NO DEVICE EVALUATION WAS PERFORMED AS THE HOSPITAL WON'T RELEASE THE WIRE FOR RETURN. HOWEVER, A FULL EVALUATION WILL BE CONDUCTED IF THE DEVICE IS RETURNED TO THE MANUFACTURER AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. WE WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS FAILURE MODE VIA OUR STANDARD COMPLAINT REVIEW PROCESS AND DATA TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    THE TIP OF THE WIRE SHEARED OFF DURING THE PROCEDURE AND HAD TO BE STENTED AGAINST THE INSIDE OF THE VESSEL ALONG WITH SOME MATERIAL FROM THE BALLOON CATHETER. THE PHYSICIANS DID NOT ATTRIBUTE THE COMPLAINT TO THE WIRE BEING DEFECTIVE BUT TO THE STENT THAT THE PATIENT HAD THAT THEY WERE TRYING TO PASS THINGS THROUGH. THE PATIENT IS CURRENTLY IN GOOD CONDITION AS OBSERVED DURING ITS FOLLOW VISIT WITH THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673731 VERRATA PRESSUR GUIDEWIRE WIRE, GUIDE, CATHETER OBJ VOLCARICA S.R.L. 10185 0243 50025617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention