BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-14¿ CONTROLWIRE®

    MDR report key: 3052457 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02225
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE DISTAL TIP SEVERELY DEFORMED AND DAMAGED, THE POLYMER COATING IS PEELING, KINKED AND BENT AT 298.7CM APPROX. FROM THE PROXIMAL END TO DISTAL END. OUTER DIAMETER IS WITHIN SPECIFICATION. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHED. THE CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. AT AN UNSPECIFIED TIME DURING PROCEDURE ATTEMPTS TO CROSS THE CTO WITH OTHER NON BSC DEVICES WERE UNSUCCESSFUL. A 300CM V-14 CONTROLWIRE GUIDE WIRE WAS INSERTED AND ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING MULTIPLES ATTEMPTS TO CROSS THE CTO THAT INCLUDED RE-TORQUING, THEN RE ADVANCE OF THE GUIDE WIRE WERE UNSUCCESSFUL. AS A RESULT, APPROXIMATELY 3CM OF THE GUIDE WIRE TIP DETACHED AT THE CTO. IT WAS DETERMINED THAT THE TIP WOULD REMAIN AS IT WAS LODGED WITHIN THE CTO. PHYSICIAN DECIDED TO CONDUCT NO FURTHER ATTEMPTS TO TREAT CTO. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE PATIENT CARE PLAN IS MONITOR WITH FOLLOW UP VISITS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, A GUIDE WIRE TIP DETACHED. THE CHRONIC TOTAL OCCLUSION (CTO) TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. AT AN UNSPECIFIED TIME DURING PROCEDURE ATTEMPTS TO CROSS THE CTO WITH OTHER NON BSC DEVICES WERE UNSUCCESSFUL. A 300CM V-14 CONTROLWIRE GUIDE WIRE WAS INSERTED AND ADVANCED TO THE TARGET LESION WITHOUT RESISTANCE. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED DURING MULTIPLES ATTEMPTS TO CROSS THE CTO THAT INCLUDED RE-TORQUING, THEN RE ADVANCE OF THE GUIDE WIRE WERE UNSUCCESSFUL. AS A RESULT, APPROXIMATELY 3CM OF THE GUIDE WIRE TIP DETACHED AT THE CTO. IT WAS DETERMINED THAT THE TIP WOULD REMAIN AS IT WAS LODGED WITHIN THE CTO. PHYSICIAN DECIDED TO CONDUCT NO FURTHER ATTEMPTS TO TREAT CTO. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE PATIENT CARE PLAN IS MONITOR WITH FOLLOW UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154286 V-14¿ CONTROLWIRE® WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74939216730010 0015719676

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other