BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTION GOLD PROBE¿

    MDR report key: 2760827 · Received September 26, 2012

    Report

    Report Number
    3005099803-2012-04177
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 2, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    KNS
    PMA / PMN Number
    K961349
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN HOWEVER; IT HAS BEEN REPORTED THAT THE PATIENT IS OVER 18 YEARS OLD. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSE AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION FOUND THAT THE DEVICE RETURNED KINKED APPROXIMATELY 6CM AND 47CM FROM THE DISTAL CERAMIC TIP. FUNCTIONALLY, WHEN THE HANDLE WAS ACTUATED, THE NEEDLE FAILED TO RETRACT. THE CATHETER WAS DISSECTED AND THE HYPOTUBE WAS FOUND TO BE FRACTURED, WHICH INHIBITED THE NEEDLE'S MOVEMENT. FURTHER MATERIAL ANALYSIS OF THE HYPOTUBE REVEALED THAT THE FRACTURE OCCURRED DUE TO A BENDING OVERLOAD. NO MATERIAL ANOMALIES WERE IDENTIFIED. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT THE NEEDLE FAILED TO RETRACT. THE EVALUATION ATTRIBUTED THE RETRACTION ISSUES TO THE FRACTURED HYPOTUBE. THE FRACTURE LIKELY OCCURRED DUE TO ANATOMICAL/PROCEDURAL FACTORS WHICH LIMITED THE DEVICE PERFORMANCE. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. 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 THAT AN INJECTION GOLD PROBE WAS USED DURING A GASTROSCOPY PROCEDURE WITHIN THE STOMACH PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER INJECTING THE SITE, THE NEEDLE FAILED TO RETRACT INTO THE INJECTION GOLD PROBE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INJECTION GOLD PROBE WAS USED DURING A GASTROSCOPY PROCEDURE WITHIN THE STOMACH PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER INJECTING THE SITE, THE NEEDLE FAILED TO RETRACT INTO THE INJECTION GOLD PROBE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS RESULTED FROM THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INJECTION GOLD PROBE¿ UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00560150 0015219077

    Patients

    Seq Age Sex Outcome Treatment
    1