BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2163638 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02451
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE DEVICE WAS HALF DEPLOYED; AS THE CLIP ASSEMBLY WAS DETACHED FROM THE BUSHING AND THE YOKE WAS STILL ATTACHED TO THE CONTROL WIRE. THE YOKE WAS ABLE TO BE ACTUATED AND DEPLOYED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. THE REPORTED EVENT OF 'CLIP FAILED TO RELEASE FROM CATHETER' WAS NOT ABLE TO BE CONFIRMED DUE TO THE CLIP ASSEMBLY NOT BEING RETURNED. HOWEVER, THE FAILURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    PATIENT IS (B)(6). (B)(4). 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 PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-02452. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEEDING GASTRIC LESION DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP WOULD NOT RELEASE FROM THE CATHETER WHEN THE PHYSICIAN TRIED TO DEPLOY THE CLIP. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-02452) WAS USED; HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP WITHOUT COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" AT THE CONCLUSION OF THE PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #'S 3005099803-2011-02451 AND 3005099803-2011-02452. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO RESOLUTION HEMOSTASIS CLIPPING DEVICES WERE USED TO TREAT A BLEEDING GASTRIC LESION DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-02451) WOULD NOT RELEASE FROM THE CATHETER WHEN THE PHYSICIAN TRIED TO DEPLOY THE CLIP. THE DEVICE WAS REMOVED FROM THE PATIENT AND A SECOND RESOLUTION CLIP (MANUFACTURER REPORT # 3005099803-2011-02452) WAS USED; HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP WITHOUT COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "GOOD" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522611 10121501C2

    Patients

    Seq Age Sex Outcome Treatment
    1