BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2073070 · Received April 29, 2011

    Report

    Report Number
    3005099803-2011-01498
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS FULLY DEPLOYED, AS THE CONTROL WIRE WAS SEPARATED PER DESIGN, AND THE PRONGS WERE BENT BACKWARDS. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CLIP DETACHED FROM TISSUE WITH OPEN PRONGS. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT YET BEEN COMPLETED. UPON 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME EVENT. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-01498 AND 3005099803-2011-01499. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01498) WAS POSITIONED WITHIN THE PATIENT'S DUODENUM. UPON OPENING THE CLIP, IT FELL OFF THE CATHETER INTO THE PATIENT'S DUODENUM. THE PHYSICIAN RETRIEVED THE CLIP USING A RETRIEVAL NET. A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01499) WAS POSITIONED WITHIN THE PATIENT'S DUODENUM AND THE SAME ISSUE OCCURRED. UPON OPENING THE CLIP, IT FELL OFF THE CATHETER INTO THE PATIENT'S DUODENUM. THE CLIP WAS LEFT INSIDE THE PATIENT IN THE OPEN POSITION. THE PROCEDURE WAS COMPLETED USING EPINEPHRINE TO CONTROL THE BLEEDING. ATTEMPTS TO OBTAIN ADDITIONAL PATIENT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME EVENT. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-01498 AND 3005099803-2011-01499. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEED IN THE DUODENUM DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01498) WAS POSITIONED WITHIN THE PATIENT'S DUODENUM. UPON OPENING THE CLIP, IT FELL OFF THE CATHETER INTO THE PATIENT'S DUODENUM. THE PHYSICIAN RETRIEVED THE CLIP USING A RETRIEVAL NET. A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-01499) WAS POSITIONED WITHIN THE PATIENT'S DUODENUM AND THE SAME ISSUE OCCURRED. UPON OPENING THE CLIP, IT FELL OFF THE CATHETER INTO THE PATIENT'S DUODENUM. THE CLIP WAS LEFT INSIDE THE PATIENT IN THE OPEN POSITION. THE PROCEDURE WAS COMPLETED USING EPINEPHRINE TO CONTROL THE BLEEDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1