BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT?

    MDR report key: 3030177 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-02280
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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. (B)(4) FOR 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.

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT WAS PERFORMED. THE NEEDLE WAS RETRACTED. THE OUTER SHEATH WAS KINKED AT THE DISTAL END OF THE OUTER HUB. WHEN THE INNER HUB WAS ACTUATED, THE NEEDLE WOULD NOT EXTEND. THE INNER SHEATH AND HUB WERE REMOVED FROM THE OUTER HUB AND SHEATH. THE INNER SHEATH WAS KINKED AT MULTIPLE LOCATIONS NEAR THE DISTAL END OF THE INNER HUB. A SYRINGE WAS FILLED WITH AIR AND WAS ATTACHED TO THE INNER HUB AND COMPRESSED; RESISTANCE WAS ENCOUNTERED. THE INNER SHEATH WAS CUT JUST PROXIMAL TO THE NEEDLE SO THAT THE SHEATH AND NEEDLE COULD BE TESTED SEPARATELY. THE SYRINGE WAS FILLED WITH AIR AND ATTACHED TO THE INNER HUB AND COMPRESSED. WHEN THE KINKS NEAR THE INNER HUB WERE STRAIGHTEN OUT, THE SYRINGE COULD BE COMPRESSED WITHOUT ISSUES. IT WAS VERIFIED THAT THE INNER SHEATH AND THE NEEDLE WERE NOT BLOCKED/OCCLUDED. MOST LIKELY, DUE TO SOME OPERATIONAL OR ANATOMICAL ASPECT THE PROCEDURE, THE WORKING LENGTH WAS KINKED. THE WORKING LENGTH KINKS WOULD NOT ALLOW THE INNER SHEATH TO MOVE FREELY WITHIN THE OUTER SHEATH. ONCE THE INNER SHEATH WAS KINKED SIGNIFICANTLY, THE NEEDLE WOULD NOT EXTEND. THE USER COULD HAVE ISSUES WITH INJECTING CONTRAST, DUE TO THE KINKS ON THE INNER SHEATH. THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL/PHYSIOLOGICAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN INTERJECT INJECTION THERAPY NEEDLE DEVICE WAS USED DURING AN ENDOSCOPIC INJECTION SCLEROTHERAPY (EIS) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THEY ATTEMPTED TO INJECT CONTRAST, HOWEVER, THE CONTRAST WOULD NOT COME OUT. THEY ALSO ATTEMPTED TO MOVE THE NEEDLE OUT FROM THE CATHETER, HOWEVER, THEY COULD NOT MOVE THE NEEDLE BY ACTUATING THE PROXIMAL HANDLE. THEY REMOVED THE CATHETER FROM THE ENDOSCOPE AND CHECKED THE MOVEMENT, BUT THEY WERE STILL UNABLE TO MOVE THE NEEDLE OUT BY ACTUATING THE PROXIMAL HANDLE. NO DAMAGE WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER INTERJECT INJECTION THERAPY NEEDLE 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 AN ENDOSCOPIC INJECTION SCLEROTHERAPY (EIS) PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THEY ATTEMPTED TO INJECT CONTRAST, HOWEVER, THE CONTRAST WOULD NOT COME OUT. THEY ALSO ATTEMPTED TO MOVE THE NEEDLE OUT FROM THE CATHETER, HOWEVER, THEY COULD NOT MOVE THE NEEDLE BY ACTUATING THE PROXIMAL HANDLE. THEY REMOVED THE CATHETER FROM THE ENDOSCOPE AND CHECKED THE MOVEMENT, BUT THEY WERE STILL UNABLE TO MOVE THE NEEDLE OUT BY ACTUATING THE PROXIMAL HANDLE. NO DAMAGE WAS NOTED TO THE DEVICE, OR DEVICE PACKAGING. ANOTHER INTERJECT INJECTION THERAPY NEEDLE 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
    133528 INTERJECT? KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518111 15642629

    Patients

    Seq Age Sex Outcome Treatment
    1