BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT¿

    MDR report key: 3013319 · Received March 20, 2013

    Report

    Report Number
    3005099803-2013-01681
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN. HOWEVER, IT WAS NOTED TO BE OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF CATHETER BEING TORN. 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.

    Additional Manufacturer Narrative · 1

    THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE COMPLAINT INCIDENT THAT THE SHEATH WAS DAMAGED. THE NEEDLE WAS RETRACTED WHEN RECEIVED. THERE WAS A TEAR NEAR THE DISTAL END OF THE OUTER SHEATH. THERE WERE NO KINKS ON THE INNER AND OUTER SHEATHS. THE TEAR WAS RECONSTRUCTED FOR A FUNCTIONAL EVALUATION. WHEN THE INNER HUB WAS ACTUATED, THE NEEDLE EXTENDED AND RETRACTED WITHOUT ISSUES. BASED ON THE EVENT DESCRIPTION, THE ISSUE WAS NOTICED OUTSIDE PATIENT DURING PREPARATION. MOST LIKELY, DUE TO SOME ASPECT OF HANDLING THE DEVICE PRIOR TO USE IN THE PROCEDURE, THE WORKING LENGTH WAS DAMAGED. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE FOR SCLEROTHERAPY FOR GASTRIC VARICES PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE DEVICE WAS FLUSHED, IT WAS NOTED THAT THE DISTAL END OF SHEATH WAS TORN. NO OTHER DAMAGE WAS NOTICED WITH THE DEVICE. THE PACKAGING WAS ALSO NOT NOTED TO BE DAMAGED. ANOTHER INTERJECT 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING A PROCEDURE FOR SCLEROTHERAPY FOR GASTRIC VARICES PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, AFTER THE DEVICE WAS FLUSHED, IT WAS NOTED THAT THE DISTAL END OF SHEATH WAS TORN. NO OTHER DAMAGE WAS NOTICED WITH THE DEVICE. THE PACKAGING WAS ALSO NOT NOTED TO BE DAMAGED. ANOTHER INTERJECT 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115711 INTERJECT¿ KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518101

    Patients

    Seq Age Sex Outcome Treatment
    1