BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7

    MDR report key: 13933177 · Received March 28, 2022

    Report

    Report Number
    3005099803-2022-01517
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    UDI-DI
    08714729201960
    PMA / PMN Number
    510K EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE PROBLEM CODE: (B)(4). MEDICAL DEVICE PROBLEM CODE: (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN; THEREFORE, A PROBLEM 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 · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 WAS USED IN THE GASTRIC FUNDUS DURING AN ENDOSCOPIC VARICEAL LIGATION (EVL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, AFTER APPROACHING THE LESION, THE PHYSICIAN PREPARED THE DEVICE TO DEPLOY THE BANDS. HOWEVER, WHEN THE PHYSICIAN ROTATED THE HANDLE, IT WAS NOTICED THAT THE HANDLE COULD NOT BE ROTATED IN A DEGREE WHICH IS LESS THAN 180 DEGREES. IT WAS REPORTED THAT THERE WAS NO VISIBLE DAMAGE NOTED ON THE HANDLE UNIT. THE DEVICE WAS REMOVED, AND STILL IT DID NOT WORK OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SPEEDBAND SUPERVIEW SUPER 7. IT WAS NOTED THAT THERE WAS NO DIFFICULTY EXPERIENCED UPON SETTING UP THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: PHOTOS OF THE COMPLAINT DEVICE OUTSIDE THE PATIENT WERE PROVIDED BY THE CUSTOMER AND SHOWED THE SIXTH AND SEVENTH BANDS HAD MOVED TOWARDS THE FOURTH AND FIFTH BANDS. ADDITIONALLY, IT WAS REPORTED THAT THE SPEEDBAND SUPERVIEW SUPER 7 DEVICE WAS USED IN THE GASTRIC FUNDUS; HOWEVER, PER THE SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR INSTRUCTIONS FOR USE, THE DEVICE IS NOT INTENDED FOR LIGATION OF ESOPHAGEAL VARICES BELOW THE GASTROESOPHAGEAL JUNCTION AND THE REPORTED ANATOMY LOCATION IS NOT DESCRIBED IN THE INDICATIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32459 SPEEDBAND SUPERVIEW SUPER 7 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC CORPORATION M00542251 0028050499 08714729201960

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male