BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203

    MDR report key: 2033520 · Received March 30, 2011

    Report

    Report Number
    3005099803-2011-01143
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    MND
    PMA / PMN Number
    K020824
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SYRINGE LINE HAD NO DAMAGE TO THE LUERS OR TUBING. THE HANDLE WAS RECEIVED WITH RESIDUE ON IT INDICATIVE OF THE DEVICE BEING USED. THE TRIP WIRE WAS WOUND AROUND THE HANDLE SPOOL ONE AND A HALF TIMES. THERE WERE NO MARKINGS IN THE SLOT OF THE HANDLE TO INDICATE THAT THE TRIP WIRE HAD BEEN CINCHED. THE PROXIMAL END OF THE TRIP WIRE IS SLIGHTLY DISTORTED AND KINKED NEAR THE HANDLE. THE LIGATOR HEAD WAS RETURNED WITHOUT ANY BANDS AND THERE WAS NO TEETH DAMAGE. THE PROXIMAL END OF THE SUTURE WAS ATTACHED TO THE DISTAL END OF THE TRIP WIRE, AND THE THREAD HAS BEEN SEPARATED FROM THE LIGATOR HEAD ASSEMBLY. A FUNCTIONAL CHECK FOUND THAT THE TRIP WIRE COULD BE CINCHED INTO THE HANDLE SLOT. IN ADDITION, THE HANDLE KNOB WAS ABLE TO BE TURNED TO TAKE UP SLACKS AND THERE WAS AN AUDIBLE "CLICK" HEARD AT EACH COMPLETE TURN OF APPROXIMATELY 180°. BASED ON THE HANDLE BEING ABLE TO FUNCTION NORMALLY AND THAT THE BANDS OF THE LIGATOR HEAD WERE MISSING, AS WELL AS NO DAMAGE TO THE TEETH OF THE LIGATOR, THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. 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 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL BAND LIGATION PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THEY TURNED THE HANDLE AGAIN AND THE BAND STILL WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THE PHYSICIAN RELEASED SUCTION AND THE VARIX BEGAN TO BLEED. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR, WHICH STOPPED THE BLEED. NO FURTHER INTERVENTION WAS REQUIRED. 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 NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR WAS USED DURING AN ESOPHAGEAL BAND LIGATION PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY ATTEMPTED TO DEPLOY A BAND AND IT WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THEY TURNED THE HANDLE AGAIN AND THE BAND STILL WOULD NOT DEPLOY OFF THE LIGATOR HEAD. THE PHYSICIAN RELEASED SUCTION AND THE VARIX BEGAN TO BLEED. THE CASE WAS COMPLETED WITH A SECOND SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATOR, WHICH STOPPED THE BLEED. NO FURTHER INTERVENTION WAS REQUIRED. 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 NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203 LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - SPENCER M00542250 13741702

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR