BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V-18¿ CONTROL WIRE¿

    MDR report key: 5773071 · Received July 6, 2016

    Report

    Report Number
    2134265-2016-05913
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 13, 2016
    Report Date
    June 13, 2016
    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
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: UNIT RETURNED IN A GENERIC PLASTIC BAG. THE UNIT RETURNED HAS DISTAL END DAMAGE, AS PART OF OVERALL VISUAL REVISION. OVERALL LENGTH COULDN'T BE MEASURED DUE TOP THE DEVICE CONDITION (DISTAL TIP DETACHED). THE WIRE WAS INSPECTED AND THE POLYMER SECTION IS DETACHED IN THE DISTAL SECTION EXPOSING THE CORE WIRE AT 297CM FROM THE PROXIMAL SECTION (3CM APPROX MISSING SEGMENT OF THE POLYMER TIP). THE DISTAL TIP END WAS NOT RETURNED. OD POLYMER SECTION DISTAL TIP END, OD MIDDLE OF THE DEVICE AND OD PROXIMAL SECTION ARE 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PEDAL PLANTAR ARTERY. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED BUT MET SOME RESISTANCE IN CROSSING THE LESION. UPON REMOVING THE DEVICE OUT TO EXCHANGE FOR ANOTHER WIRE, A CENTIMETER OF THE TIP OF THE WIRE BROKE OFF. A FLUOROSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE FLOW OF THE VESSEL WAS NOT LIMITING. THE BROKEN TIP LODGED IN THE SUBINTIMAL ARTERY AND WAS DIFFICULT TO RETRIEVED, SO THE PHYSICIAN DECIDED TO JUST LEAVE THE TIP AS IT IS SINCE THE FLOW OF THE VESSEL WAS NOT LIMITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE PEDAL PLANTAR ARTERY. A 300CM, 8CM POLY TIP V-18 CONTROL WIRE WAS ADVANCED BUT MET SOME RESISTANCE IN CROSSING THE LESION. UPON REMOVING THE DEVICE OUT TO EXCHANGE FOR ANOTHER WIRE, A CENTIMETER OF THE TIP OF THE WIRE BROKE OFF. A FLUOROSCOPY WAS PERFORMED AND IT WAS NOTED THAT THE FLOW OF THE VESSEL WAS NOT LIMITING. THE BROKEN TIP LODGED IN THE SUBINTIMAL ARTERY AND WAS DIFFICULT TO RETRIEVED, SO THE PHYSICIAN DECIDED TO JUST LEAVE THE TIP AS IT IS SINCE THE FLOW OF THE VESSEL WAS NOT LIMITING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425835 V-18¿ CONTROL WIRE¿ WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M001468540 18703909

    Patients

    Seq Age Sex Outcome Treatment
    1 Other