BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 2676202 · Received July 31, 2012

    Report

    Report Number
    3005099803-2012-03091
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    July 6, 2012
    Report Date
    July 9, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED DEVICE CONFIRMED THAT THE NEEDLE WAS BLOCKED/OCCLUDED. A VISUAL EVALUATION WAS PERFORMED; NO DAMAGE OR ANOMALIES WERE OBSERVED. A FUNCTIONAL EVALUATION WAS PERFORMED AND THE NEEDLE EXTENDED AND RETRACTED AS INTENDED. THE DEVICE WAS TESTED TO IDENTIFY IF THE LUMEN WAS OCCLUDED. A SYRINGE FILLED WITH AIR WAS ATTACHED TO THE INNER HUB AND COMPRESSED; THE SYRINGE WAS NOT ABLE TO BE COMPRESSED. A PIN GAUGE WAS INSERTED THROUGH THE NEEDLE INTO THE PROXIMAL END OF THE NEEDLE. SOME RESISTANCE WAS MET, AND A SMALL PIECE OF SILICONE WAS EXTRACTED FROM THE INNER DIAMETER. THIS SUBSTANCE IS LIKELY 'MDX,' A SILICONE BASED LUBRICANT APPLIED TO THE OUTSIDE OF THE INNER SHEATH DURING MANUFACTURING. THIS IS RESIDUAL FROM THE FABRICATION PROCESS, AND DOES NOT APPEAR TO BE A FOREIGN CONTAMINANT. IN ADDITION, MDX WAS EVALUATED FOR BIOCOMPATIBILITY AND MET BIOCOMPATIBILITY REQUIREMENTS.A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF NEEDLE BEING BLOCKED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY WERE NOT ABLE TO FLUSH ANY MATERIAL THROUGH THE NEEDLE. NO DAMAGE, OR KINKS, WAS NOTED TO THE DEVICE. 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 PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY WERE NOT ABLE TO FLUSH ANY MATERIAL THROUGH THE NEEDLE. NO DAMAGE, OR KINKS, WAS NOTED TO THE DEVICE. 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 PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THEY WERE NOT ABLE TO FLUSH ANY MATERIAL THROUGH THE NEEDLE. NO DAMAGE, OR KINKS, WAS NOTED TO THE DEVICE. 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 M00518311 14966768

    Patients

    Seq Age Sex Outcome Treatment
    1