BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-18¿ CONTROL WIRE¿

    MDR report key: 2993119 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01281
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 END DETACHED/SEPARATED AND SEVERELY DAMAGED; AND THE DISTAL END OF THE GUIDEWIRE IS SEVERELY BENT AT 243CM FROM THE PROXIMAL END TO DISTAL END. GUIDE WIRE OUTER DIAMETER WITHIN DEVICE SPECIFICATIONS. SEM ANALYSIS REVEALED THAT THE FAILURE OCCURRED DUE TO A FATIGUE EVENT IN A BENDING MOMENT WITH A FINAL TORSION OVERLOAD. 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 LASER ATHERECTOMY TREATMENT PROCEDURE, A TIP DETACHMENT OCCURRED. THE LOCATION OF THE TARGET LESION WAS NOT SPECIFIED. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE TIP OF A V-18 CONTROL WIRE GUIDE WIRE "CAME OFF". THE DETACHED TIP WAS RETRIEVED USING A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS NOT LISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LASER ATHERECTOMY TREATMENT PROCEDURE, A TIP DETACHMENT OCCURRED. THE LOCATION OF THE TARGET LESION WAS NOT SPECIFIED. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE TIP OF A V-18 CONTROL WIRE GUIDE WIRE "CAME OFF". THE DETACHED TIP WAS RETRIEVED USING A SNARE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS NOT LISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98105 V-18¿ CONTROL WIRE¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) M001468600 0015240637

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention