BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2760826 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04344
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE PATIENT IS OVER 18 YEARS. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-04343 ADDRESSES THE FIRST HEMOSTATIC CLIPPING DEVICE, MANUFACTURE REPORT # 3005099803-2012-04344 ADDRESSED THE SECOND HEMOSTATIC CLIPPING DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT TWO HEMOSTATIC CLIPPING DEVICES WERE USED A DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE STOMACH ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP WOULD NOT RELEASE FROM THE CATHETER AFTER DEPLOYMENT. THEY HAD TO PULL BOTH CLIPS OFF THE SITE IN THE STOMACH AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A THIRD HEMOSTATIC CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINT DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2012-04343 ADDRESSES THE FIRST HEMOSTATIC CLIPPING DEVICE, MANUFACTURE REPORT # 3005099803-2012-04344 ADDRESSED THE SECOND HEMOSTATIC CLIPPING DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT TWO HEMOSTATIC CLIPPING DEVICES WERE USED A DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE STOMACH ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP WOULD NOT RELEASE FROM THE CATHETER AFTER DEPLOYMENT. THEY HAD TO PULL BOTH CLIPS OFF THE SITE IN THE STOMACH AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A THIRD HEMOSTATIC CLIP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610 ML000321C3

    Patients

    Seq Age Sex Outcome Treatment
    1