BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204

    MDR report key: 1924248 · Received December 14, 2010

    Report

    Report Number
    3005099803-2010-05167
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2010. DURING THE PROCEDURE, THE BANDER WAS POSITIONED AT THE TARGET SITE WITHIN THE ESOPHAGUS FOR THE BANDING OF VARICES. HOWEVER, DURING DEPLOYMENT OF THE FIRST BAND, THREE BANDS SIMULTANEOUSLY RELEASED ONTO THE VARIX. ALL THREE BANDS REMAINED AFFIXED ONTO THE VARIX. THE PHYSICIAN NOTED THE HANDLE WAS ROTATED ONLY ONCE AND THE AUDIBLE "CLICK" WAS HEARD. ADDITIONAL BANDS WERE DEPLOYED FROM THE BANDER SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING THIS SPEEDBAND SUPERVIEW 7 BANDER. POST PROCEDURE, THE PATIENT COMPLAINED OF DYSPHAGIA, DIFFICULTY SWALLOWING BOTH SOLIDS AND LIQUIDS. THE PHYSICIAN REPORTED THAT THE THREE BANDS THAT HAD DEPLOYED TOGETHER HAD GRASPED MORE TISSUE THAN DESIRED. THE PHYSICIAN ATTRIBUTES THIS TO THE DYSPHAGIA. THE PATIENT INCURRED A PROLONGED HOSPITAL STAY. THE PHYSICIAN PRESCRIBED THE PATIENT A MEDICATION FOR HYPERTENSION, WHICH WAS REPORTED NOT BE RELATED TO THIS EVENT. NO OTHER TREATMENT HAS BEEN ADMINISTERED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE THAT THE PATIENT WAS HOSPITALIZED AND STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4204 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542251

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O