BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP CLIPPING DEVICE

    MDR report key: 2163619 · Received July 15, 2011

    Report

    Report Number
    3005099803-2011-02452
    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

    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.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE CLIP ASSEMBLY WAS LOCATED JUST INSIDE THE OVER SHEATH. THE SHEATH GRIP WAS USED TO EXPOSED THE CLIP, THEN THE CLIP ASSEMBLY WAS DEPLOYED AS DESIGNED. TWO DISTINCT CLICKS WERE HEARD. THE CONDITION OF THE RETURNED INCIDENT DEVICE SHOWED NO EVIDENCE OF THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-02451. 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 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 M00522610 10122006C2

    Patients

    Seq Age Sex Outcome Treatment
    1