BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUGE?

    MDR report key: 3934019 · Received July 15, 2014

    Report

    Report Number
    2134265-2014-04092
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    DQX
    PMA / PMN Number
    K973945
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: UNIT WAS RETURNED WITH ITS ORIGINAL POUCH. THE UNIT RETURNED HAS THE WIRE BROKEN, AS PART OF OVERALL VISUAL REVISION. UNIT RETURNED MATCHES WITH UPN PROVIDED BY THE CUSTOMER. VISUAL INSPECTION WAS PERFORMED AND THE DEVICE RETURNED WAS FRACTURED IN TWO SECTIONS; MOREOVER, THE SPRING TIP AND THE BODY ON BOTH SECTIONS WERE FOUND BENT. ALL THE OUTER DIAMETER (OD) WERE TAKEN AND COMPARED AND ALL OF THEM ARE ACCORDING TO 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 GUIDE WIRE FRACTURE OCCURRED. A 182CM LUGE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. AT THE END OF THE PROCEDURE, THE WIRE WAS REMOVED FROM THE BODY AND THE BACK PORTION OF THE GUIDE WIRE BROKE OFF. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT GUIDE WIRE FRACTURE OCCURRED. A 182CM LUGE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. AT THE END OF THE PROCEDURE, THE WIRE WAS REMOVED FROM THE BODY AND THE BACK PORTION OF THE GUIDE WIRE BROKE OFF. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412607 LUGE? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) H7491213001J2 0016744128

    Patients

    Seq Age Sex Outcome Treatment
    1