BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERJECT?

    MDR report key: 3173300 · Received June 17, 2013

    Report

    Report Number
    3005099803-2013-05233
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FCG
    PMA / PMN Number
    K012864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT: INTERJECT NEEDLE OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2013-05232 AND #3005099803-2013-05233 FOR A DESCRIPTION OF THE OTHER DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO INTERJECT INJECTION THERAPY NEEDLE DEVICES WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, DURING PREPARATION AS THEY WERE PRIMING THE CATHETER, THEY NOTED THAT NO INK WAS ABLE TO COME OUT OF THE INTERJECT NEEDLE. THEY USED A SECOND INTERJECT NEEDLE, BUT THE SAME ISSUE OCCURRED AND THE PHYSICIAN DECIDED TO NO LONGER USE THE SAID DEVICES. THE PROCEDURE WAS COMPLETED USING A NEEDLEKNIFE AND A PLASTIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENTS' CONDITION WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274445 INTERJECT? KIT, NEEDLE, BIOPSY FCG BOSTON SCIENTIFIC - SPENCER M00518151 15756783

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR