BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14? CONTROLWIRE®

    MDR report key: 3002204 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01443
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - THE DEVICE PRESENTS THE COATING PEELING AT ITS MOST DISTAL SIDE (ABOUT 0.7CM) ALSO IT IS BENT, MOREOVER, THE DEVICE IS KINKED AT 23CM APPROX. FROM PROXIMAL END, HOWEVER THERE IS NO EVIDENCE OF CORE WIRE FRACTURED. ALL THE OUTER DIAMETER MEASUREMENTS ARE WITHIN THE SPECIFICATIONS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT, GUIDEWIRE TIP DETACHED. THE ACCESS WAS GAINED ANTEGRADE FROM THE RIGHT. THE STENOSIS WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE V-14 SHORT TAPER 182CM STRAIGHT TIP CONTROLWIRE MAKES A LOOP WHILE ADVANCING. THE PHYSICIAN ATTEMPTED TO RESOLVE THE LOOP BY SLIGHTLY TURNING THE GUIDE WIRE AND TRIED TO CAREFULLY GET THE GUIDE WIRE BACK INTO THE SUPPORT CATHETER, BUT THE TIP DETACHED AND REMAINED IN THE CLOSED SIDE BRANCH. THERE WAS NO CONSEQUENCE DUE TO THE CLOSED BRANCH. THE GUIDE WIRE WAS REMOVED AND REPLACED WITH A VICTORY GUIDE WIRE. NO ATTEMPT TO REMOVE THE BROKEN TIP WAS MADE. A COYOTE BALLOON 2.5X40MM WAS THEN INFLATED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PATIENT COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) FOR TREATMENT, GUIDEWIRE TIP DETACHED. THE ACCESS WAS GAINED ANTEGRADE FROM THE RIGHT. THE STENOSIS WAS LOCATED IN THE ANTERIOR TIBIAL ARTERY. THE V-14 SHORT TAPER 182CM STRAIGHT TIP CONTROL WIRE MAKES A LOOP WHILE ADVANCING. THE PHYSICIAN ATTEMPTED TO RESOLVE THE LOOP BY SLIGHTLY TURNING THE GUIDE WIRE AND TRIED TO CAREFULLY GET THE GUIDE WIRE BACK INTO THE SUPPORT CATHETER, BUT THE TIP DETACHED AND REMAINED IN THE CLOSED SIDE BRANCH. THERE WAS NO CONSEQUENCE DUE TO THE CLOSED BRANCH. THE GUIDE WIRE WAS REMOVED AND REPLACED WITH A VICTORY GUIDE WIRE. NO ATTEMPT TO REMOVE THE BROKEN TIP WAS MADE. A COYOTE BALLOON 2.5X40MM WAS THEN INFLATED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PATIENT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105365 V-14? CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74939216718210 15516099

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RUBICON .014 SUPPORT CATHETER| CROSSOVER SHEATH 6FR| TERUMO SHEATH 4FR CORDIS| TERUMO STARTER WIRE