BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PT²?

    MDR report key: 3842656 · Received June 2, 2014

    Report

    Report Number
    2134265-2014-03284
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    UPDATE: DEVICE AVAIL. FOR EVAL. DEVICE EVALUATED BY MANUFACTURER: A VISUAL EXAMINATION IDENTIFIED THE GUIDEWIRE RETURNED STILL LOADED IN A FOREIGN CATHETER. THE WIRE WAS REMOVED FROM THE CATHETER, RESISTANCE WAS FELT DURING REMOVAL. THE DISTAL END WAS FOUND BENT. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR# 2134265-2014-03133. IT WAS REPORTED THAT DURING A TIBIAL VESSEL PREDILATATION, CATHETER STUCK ON THE GUIDEWIRE. PHYSICIAN WAS TREATING A LESION WITHIN THE TIBIAL VESSEL, VIA THE IPSILATERAL WITH A RUBICON 035 AND A ZIPWIRE WITH NO COMPLICATIONS. THE GUIDEWIRE WAS EXCHANGED FOR A PT2 AND DURING ADVANCEMENT OF THE RUBICON .014, IT GOT STUCK AND IT COULDN'T BE MOVED. BOTH DEVICES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TIBIAL VESSEL PREDILATATION, CATHETER STUCK ON THE GUIDEWIRE. PHYSICIAN WAS TREATING A LESION WITHIN THE TIBIAL VESSEL, VIA THE IPSILATERAL WITH A RUBICON 035 AND A ZIPWIRE WITH NO COMPLICATIONS. THE GUIDEWIRE WAS EXCHANGED FOR A PT2 AND DURING ADVANCEMENT OF THE RUBICON .014, IT GOT STUCK AND IT COULDN'T BE MOVED. BOTH DEVICES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320801 PT²? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74938931042

    Patients

    Seq Age Sex Outcome Treatment
    1