BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 2001529 · Received February 25, 2011

    Report

    Report Number
    3005099803-2011-00643
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 4, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS HALF DEPLOYED, AS THE YOKE WAS STILL ATTACHED TO THE CONTROL WIRE, AND WAS NOT RETURNED. FUNCTIONALLY, THE YOKE WAS ACTUATED AND DEPLOYED. IT WAS ALSO NOTICED THAT THERE WAS A KINK IN THE CONTROL WIRE. 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 LOT # 10071302C2 FOR THE REPORTED EVENT. BASED ON THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, IT IS PROBABLE THAT THE FAILURE OF THE CLIP TO RELEASE FROM THE CATHETER WAS DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE; THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    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, 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 RESOLUTION CLIP DEVICE WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY HAD DIFFICULTLY GETTING THE CLIP TO RELEASE FROM THE CATHETER . IT IS UNKNOWN IF THE CLIP GRASPED ONTO THE TISSUE AND IF THERE WAS ANY BLEEDING. SHE STATED THAT THEY INTENTIONALLY MISFIRED THE CLIP INTO THE PATIENT TO GET THE CLIP OFF THE DELIVERY CATHETER AND THE CLIP WAS LEFT IN THE PATIENT TO PASS NATURALLY. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY HAD DIFFICULTLY GETTING THE CLIP TO RELEASE FROM THE CATHETER . IT IS UNKNOWN IF THE CLIP GRASPED ONTO THE TISSUE AND IF THERE WAS ANY BLEEDING. SHE STATED THAT THEY INTENTIONALLY MISFIRED THE CLIP INTO THE PATIENT TO GET THE CLIP OFF THE DELIVERY CATHETER AND THE CLIP WAS LEFT IN THE PATIENT TO PASS NATURALLY. THE CASE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP DEVICE. 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 FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10071302C2

    Patients

    Seq Age Sex Outcome Treatment
    1