BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3881256 · Received June 18, 2014

    Report

    Report Number
    3005099803-2014-02257
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FHN
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. GIVEN THE EVENT DESCRIPTION AND THE DEVICE NOT BEING RETURNED, THERE IS NO ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE ESOPHAGUS FOR A VARICEAL BLEED DURING A GASTROSCOPY PROCEDURE PERFORMED ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN WENT TO DEPLOY THE BAND, THE PLASTIC RING OF THE LIGATOR HOUSING DETACHED AND GOT STUCK IN THE PATIENT'S ESOPHAGUS. THEY WERE UNABLE TO RETRIEVE THE RING OUT OF THE PATIENT. A SECOND SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357340 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, HEMORRHOIDAL FHN BOSTON SCIENTIFIC - SPENCER M00542253 16063499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention