BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-18? CONTROL WIRE?

    MDR report key: 4132854 · Received October 1, 2014

    Report

    Report Number
    2134265-2014-06186
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K033742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: 1932. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE UNIT RETURNED HAS THE DISTAL END DAMAGE, AS PART OF OVERALL VISUAL REVISION. A VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: THE DISTAL TIP PEELED. ALL THE EXTERNAL OUTER DIAMETER MEASUREMENTS WERE TAKEN AND ALL OF THEM MET SPECIFICATIONS. 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 COATING DETACHMENT OCCURRED. THE COMPLETELY OCCLUDED TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. A 300CM V-18¿ CONTROL WIRE¿ GUIDE WIRE WAS INTRODUCED THROUGH A NON-BSC MINI INTRODUCER AND INTO THE PERONEAL ARTERY. WHEN THE V-18 GUIDE WIRE WAS REMOVED, IT WAS NOTED THAT THE GUIDE WIRE CAUGHT THE NON-BSC DEVICE. THE HYDROPHILIC COATING CAME OFF OF THE V-18 GUIDE WIRE AND WAS LEFT IN THE PERONEAL ARTERY. THE COATING WAS NOT REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COATING DETACHMENT OCCURRED. THE COMPLETELY OCCLUDED TARGET LESION WAS LOCATED IN AN UNSPECIFIED VESSEL. A 300CM V-18¿ CONTROL WIRE¿ GUIDE WIRE WAS INTRODUCED THROUGH A NON-BSC MINI INTRODUCER AND INTO THE PERONEAL ARTERY. WHEN THE V-18 GUIDE WIRE WAS REMOVED, IT WAS NOTED THAT THE GUIDE WIRE CAUGHT THE NON-BSC DEVICE. THE HYDROPHILIC COATING CAME OFF OF THE V-18 GUIDE WIRE AND WAS LEFT IN THE PERONEAL ARTERY. THE COATING WAS NOT REMOVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613395 V-18? CONTROL WIRE? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M001468540 16868805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other