BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 2183402 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02529
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF FLUID NOT PASSING THROUGH THE NEEDLE. 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS EVALUATED. A VISUAL ASSESSMENT WAS PERFORMED, WHICH REVEALED THAT RESIDUE WAS PRESENT ON THE NEEDLE AND HUB; SOME OF THE RESIDUE APPEARS TO BE CONTRAST. NO DAMAGE WAS OBSERVED TO THE DEVICE. A FUNCTIONAL EVALUATION WAS THEN PERFORMED ON THE DEVICE. THE CONDITION OF THE DEVICE WAS CONSISTENT WITH THE REPORTED COMPLAINT THAT THE DEVICE WAS OCCLUDED. A SYRINGE WAS ATTACHED TO THE HUB AND AN ATTEMPT WAS MADE TO INJECT AIR THROUGH THE LUMEN. RESISTANCE WAS FELT; AIR WAS NOT ABLE TO BE INJECTED THROUGH THE DEVICE. A 0.009¿PIN GAUGE WAS INSERTED INTO THE NEEDLE AND RESIDUE WAS ABLE TO BE REMOVED. THE SYRINGE REATTACHED TO THE HUB AND WAS ABLE TO SUCCESSFULLY INJECT AIR THROUGH THE LUMEN. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE 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 INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A COLONOSCOPY FOR ELEVATION OF A POLYP. ACCORDING TO THE COMPLAINANT, WHEN THE SURGEON TRIED TO INJECT THROUGH THE NEEDLE, HE HAD A LOT OF TROUBLE GETTING ANY FLUID TO PASS THROUGH THE CATHETER AND NEEDLE. THERE WAS NO DAMAGE NOTED TO THE DEVICE, OR PACKAGING, PRIOR TO PLACING IT DOWN THE SCOPE; THE DEVICE WAS NOT TESTED PRIOR TO USE. 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 STABLE.

    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 FOR ELEVATION OF A POLYP. ACCORDING TO THE COMPLAINANT, WHEN THE SURGEON TRIED TO INJECT THROUGH THE NEEDLE, HE HAD A LOT OF TROUBLE GETTING ANY FLUID TO PASS THROUGH THE CATHETER AND NEEDLE. THERE WAS NO DAMAGE NOTED TO THE DEVICE, OR PACKAGING, PRIOR TO PLACING IT DOWN THE SCOPE; THE DEVICE WAS NOT TESTED PRIOR TO USE. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERJECT¿ KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518351 12274198

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR