BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7?

    MDR report key: 3231545 · Received July 17, 2013

    Report

    Report Number
    3005099803-2013-07108
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    April 11, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UF/IMPORTER REPORT # (B)(4). PATIENT WEIGHT WAS (B)(6). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS UNDERGOING AN EGD IN THE UPPER ESOPHAGUS FOR ESOPHAGEAL VARICES. AFTER INTUBATING THE ESOPHAGUS WITH THE DEVICE IN PLACE, THE PATIENT EXPERIENCED TRANSIENT DESATURATION, SO THE SCOPE WAS REMOVED. THE DEVICE LIGATOR HEAD CAME OFF AND WAS LODGED IN THE UPPER ESOPHAGEAL SPHINCTER. REPEATED ATTEMPTS WERE MADE TO REMOVE THE LIGATOR HEAD WITH BOTH FORCEPS AND A BASKET; THESE WERE NOT SUCCESSFUL. PEDIATRIC SURGERY WAS CALLED TO THE OPERATING ROOM TO ASSIST AND THEY WERE ABLE TO SUCCESSFULLY REMOVE THE LIGATOR HEAD WITH A LARYNGOSCOPE AND MAGILL FORCEPS. THE PATIENT WAS EASILY RE-INTUBATED WITH THE ENDOSCOPE, AND AIR WAS REMOVED FROM THE STOMACH. THE ESOPHAGUS WAS EXAMINED, AND NO DAMAGE OR LESIONS WERE FOUND. A DECISION WAS MADE NOT TO RE-ATTEMPT BANDING GIVEN RISK OF EDEMA IN THE UPPER ESOPHAGUS. THE PHYSICIAN NOTED THAT THE TRANSIENT DESATURATION WAS NOT CAUSED BY THE ISSUE WITH THE SPEEDBAND DEVICE. 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
    332276 SPEEDBAND SUPERVIEW SUPER 7? LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542253 15815731

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO Required Intervention