BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14? CONTROLWIRE®

    MDR report key: 3131669 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03473
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K112745
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. HE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, THE TIP OF THE GUIDE WIRE BROKE OFF INSIDE THE PATIENT'S BODY. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND "HEAVILY" CALCIFIED PERONEAL ARTERY. THE ARTERY WAS NOTED TO BE "SHUT DOWN". THE PHYSICIAN ADVANCED A NON-BSC SUPPORT CATHETER INTO THE TARGET LESION. AFTER, A 300CM V-14 CONTROLWIRE GUIDE WIRE WAS ADVANCED AND RESISTANCE WAS ENCOUNTERED UPON INTRODUCTION OF THE DEVICE INTO THE SUPPORT CATHETER. THE PHYSICIAN FORCEFULLY ADVANCED THE DEVICE INTO THE LESION THAT IT PROLAPSED INTO THE ARTERY. AS IT WAS RETRACTED, A BLACK LINE WAS SEEN IN THE ANGIOGRAM. AND AS IT WAS INSPECTED, THE DISTAL OUTER COIL OF THE GUIDEWIRE WAS NOTED TO HAVE "SHEARED OFF". THE BROKEN PART OF THE DEVICE WAS LEFT INSIDE AND NO INTERVENTION WAS MADE TO REMOVE IT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234161 V-14? CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74939216930010 15689630

    Patients

    Seq Age Sex Outcome Treatment
    1 Other