BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2760820 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04342
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 31, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED FULLY DEPLOYED AND WITH THE CLIP ASSEMBLY WITHIN THE OVERSHEATH. THE CONTROL WIRE WAS SEPARATED PER DESIGN. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT CONSISTENT WITH THE COMPLAINT THAT THE CLIP ASSEMBLY FAILED TO RELEASE FROM THE DELIVERY CATHETER. THE DEVICE EVALUATION REVEALED NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. THEREFORE, THE COMPLAINT WAS NOT CONFIRMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2012 THAT A HEMOSTATIC CLIPPING DEVICE WAS USED A DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2012 THAT A HEMOSTATIC CLIPPING DEVICE WAS USED A DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN THE ESOPHAGUS ON (B)(6) 2012. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE, THE CLIP WOULD NOT RELEASE FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 ML000122C2

    Patients

    Seq Age Sex Outcome Treatment
    1