BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 2223596 · Received August 25, 2011

    Report

    Report Number
    3005099803-2011-02886
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS EVALUATED; THE INITIAL REPORT OF THE SALINE NOT ADVANCING THROUGH THE NEEDLE WAS NOT ABLE TO BE CONFIRMED. A FUNCTIONAL EVALUATION FOUND THAT THE INNER LUMEN AND NEEDLE WERE NOT OCCLUDED AS AIR/WATER WAS ABLE TO INJECTED THROUGH DEVICE. A VISUAL INSPECTION OF THE DEVICE FOUND A SMALL PORTION OF THE NEEDLE EXTENDED FROM THE OUTER SHEATH. NO DAMAGE WAS OBSERVED TO THE OUTER SHEATH, TO THE OUTER HUB, OR TO THE PORTION OF THE EXPOSED NEEDLE. THE NEEDLE COULD NOT BE FULLY EXTENDED, BUT COULD BE FULLY RETRACTED. THE INNER HUB WAS REMOVED FROM THE OUTER HUB AND REVEALED THAT THE INNER SHEATH WAS KINKED NEAR THE INNER HUB; THE KINK IN THE INNER SHEATH RESTRICTED MOVEMENT OF THE NEEDLE. THE ROOT CAUSE OF THE INITIAL REPORT WAS NOT ABLE TO BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. 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 AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A COLONOSCOPY WITH A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO INJECT SALINE TO RAISE A POLYP UP FROM THE MUCOSA FOR REMOVAL, SALINE WOULD NOT ADVANCE THROUGH THE NEEDLE. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A COLONOSCOPY WITH A POLYPECTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO INJECT SALINE TO RAISE A POLYP UP FROM THE MUCOSA FOR REMOVAL, SALINE WOULD NOT ADVANCE THROUGH THE NEEDLE. ANOTHER INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERJECT¿ KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518161 14207130

    Patients

    Seq Age Sex Outcome Treatment
    1