BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1932704 · Received December 20, 2010

    Report

    Report Number
    3005099803-2010-05217
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE SHEATH WAS MISSING AND THE CLIP ASSEMBLY WAS NOT RETURNED. THE DEVICE WAS HALF DEPLOYED AND THE CONTROL WIRE WAS SEPARATED PER DESIGN. THE MOST PROBABLE ROOT CAUSE HAS BEEN DETERMINED TO BE USER ERROR. AS INDICATED IN THE EVENT DESCRIPTION, THE DEVICE WAS BEING USED IN A MANNER INCONSISTENT WITH THE DIRECTIONS FOR USE (DFU), AS THE HEMOCLIP SHEATHS ARE NOT INTENDED FOR REMOVAL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS HOWEVER, AN EVALUATION HAS NOT BEEN PERFORMED AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-05216 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES HAD ISSUES WHEN USED IN THE STOMACH DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6), 2010. IT WAS INITIALLY REPORTED WHEN THE PACKAGES OF THE TWO CLIPS WERE OPENED, THERE WERE NO CLIPS PRESENT ON EITHER DEVICE OR IN ITS PACKAGING AND THERE WAS NO DAMAGE TO EITHER PACKAGING NOTED. FURTHER INFORMATION RECEIVED FROM THE COMPLAINANT ON NOVEMBER 30, 2010, WHICH IS CONTRARY TO WHAT WAS INITIALLY REPORTED, REVEALED THE FOLLOWING: THE CLIPS WERE PRESENT ON BOTH DEVICES. THE COMPLAINANT ATTEMPTED TO REMOVE THE OVER SHEATH FROM BOTH DEVICES AND EXCESSIVE FORCE WAS REQUIRED. THE COMPLAINANT REPORTED THAT IT WAS "AS IF THE CLIP WAS GLUED TO THE INSIDE OF THE OVER SHEATH." AFTER REMOVING THE SHEATH FROM THE DEVICES, BOTH CLIPS APPEARED TO BE BROKEN AND THAT A PIECE OF THE CLIP WAS MISSING ON BOTH DEVICES. ANOTHER RESOLUTION CLIP WAS USED FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT REMAINED WITHIN THE HOSPITAL FOR OBSERVATION BUT WAS DISCHARGED WITHIN 24 HOURS OF THE PROCEDURE. THE PATIENT WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-05216 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION CLIP DEVICES HAD ISSUES WHEN USED IN THE STOMACH DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE PERFORMED ON (B)(6) 2010. IT WAS INITIALLY REPORTED WHEN THE PACKAGES OF THE TWO CLIPS WERE OPENED, THERE WERE NO CLIPS PRESENT ON EITHER DEVICE OR IN ITS PACKAGING AND THERE WAS NO DAMAGE TO EITHER PACKAGING NOTED. FURTHER INFORMATION RECEIVED FROM THE COMPLAINANT ON (B)(6) 2010, WHICH IS CONTRARY TO WHAT WAS INITIALLY REPORTED, REVEALED THE FOLLOWING: THE CLIPS WERE PRESENT ON BOTH DEVICES. THE COMPLAINANT ATTEMPTED TO REMOVE THE OVER SHEATH FROM BOTH DEVICES AND EXCESSIVE FORCE WAS REQUIRED. THE COMPLAINANT REPORTED THAT IT WAS "AS IF THE CLIP WAS GLUED TO THE INSIDE OF THE OVER SHEATH." AFTER REMOVING THE SHEATH FROM THE DEVICES, BOTH CLIPS APPEARED TO BE BROKEN AND THAT A PIECE OF THE CLIP WAS MISSING ON BOTH DEVICES. ANOTHER RESOLUTION CLIP WAS USED FROM A DIFFERENT LOT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT REMAINED WITHIN THE HOSPITAL FOR OBSERVATION BUT WAS DISCHARGED WITHIN 24 HOURS OF THE PROCEDURE. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10052603C2

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR