BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHERLOCK 3CG SENSOR INTERNATIONAL

    MDR report key: 7971507 · Received October 16, 2018

    Report

    Report Number
    3006260740-2018-02906
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    October 16, 2018
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741154560
    PMA / PMN Number
    K113808
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A HISTORY REVIEW IS NOT POSSIBLE, AS NO SERIAL NUMBER OF THE DEVICE HAS BEEN PROVIDED BY THE COMPLAINANT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    A STUDY OF THE CLINICAL IMPACT OF THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM FOR PERIPHERALLY INSERTED CENTRAL CATHETERS IN JAPAN WAS PUBLISHED IN THE JOURNAL OF INTERNATIONAL MEDICAL RESEARCH. THE STUDY WAS FOUND AND REPORTED TO FA BY BD MARKETING DIRECTOR. THE STUDY REPORTED THREE CASES OF TECHNICAL FAILURE ATTRIBUTED TO THE FOLLOWING: ONE CASE OF INABILITY TO INTERPRET THE MAGNETIC GUIDANCE, THUS REQUIRING FLUOROSCOPY, AND TWO CASES OF THE INABILITY TO EXTEND THE CATHETER FORWARD THROUGH THE SUBCLAVIAN VEIN. THERE WERE 18 MALPOSITIONS REPORTED OUT OF 111 PROCEDURES IN THE STUDY. AMONG THE 18 CASES, 1 OCCURRED AT THE UPPER SVC, 6 AT THE MIDDLE SVC, AND 11 AT THE RIGHT ATRIUM. ONE UPPER SVC CASE WAS EXTENDED FURTHER FOR REPOSITIONING, AND THREE RIGHT ATRIUM CASES WERE RETRACTED TO THE CAJ. THE OTHER 14 CASES COULD NOT BE REPOSITIONED BECAUSE THEY WERE IN AN ADEQUATE POSITION ACCORDING TO THE EUROPEAN GUIDELINES -- FROM THE MIDDLE SVC TO THE HIGH RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811615 SHERLOCK 3CG SENSOR INTERNATIONAL CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A 00801741154560

    Patients

    Seq Age Sex Outcome Treatment
    1