BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACK-UP MEIER

    MDR report key: 3133273 · Received May 29, 2013

    Report

    Report Number
    2134265-2013-03721
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K011906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE UNIT RETURNED PRESENTS THE DISTAL TIP DAMAGED, AS PART OF OVERALL VISUAL REVISION. VISUAL INSPECTION WAS PERFORMED AND THE DEVICE PRESENTS: THE SPRING TIP SEVERELY KINKED AT 179.9CM AND AT 180.5CM APPROX. FROM THE PROXIMAL END. ALL THE 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 CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR AN UNSPECIFIED TREATMENT PROCEDURE, A GUIDE WIRE TIP SPLIT WAS NOTED. DURING UNPACKING THE .035IN, 185CM, J TIP BACK-UP MEIER GUIDE WIRE TIP WAS NOTED TO BE DAMAGED, KINKED, AND "SPLIT". NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING UNPACKING FOR AN UNSPECIFIED TREATMENT PROCEDURE, A GUIDE WIRE TIP SPLIT WAS NOTED. DURING UNPACKING THE .035IN, 185CM, J TIP BACK-UP MEIER GUIDE WIRE TIP WAS NOTED TO BE DAMAGED, KINKED, AND "SPLIT." NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234790 BACK-UP MEIER WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H965SCH306001 15890411

    Patients

    Seq Age Sex Outcome Treatment
    1