BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM RX CANNULA

    MDR report key: 1413952 · Received July 14, 2009

    Report

    Report Number
    3005099803-2009-03307
    Event Type
    Injury
    Date Received
    July 14, 2009
    Date of Event
    June 17, 2009
    Report Date
    June 19, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NML
    PMA / PMN Number
    K970054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON 06/19/2009, THAT A TANDEM REX CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN 2009. ACCORDING TO THE COMPLAINANT, AN ERCP WAS COMPLETED WITH THIS DEVICE. A LITHOTRIPSY PROCEDURE WAS THEN PERFORMED WITH ANOTHER DEVICE AND A RETRIEVAL BALLOON. FOLLOWING THE LITHOTRIPSY, A CONTRAST TEST WAS CONDUCTED AND IT WAS NOTICED THAT RO MARKER OF THE CANNULA REMAINED IN THE BILE DUCT. THE PHYSICIAN INDICATED HE WAS CONCERNED THAT THE RO MARKER REMAINED IN THE DUCT. HOWEVER, THE PROCEDURE WAS COMPLETED AT THAT TIME. ANOTHER PROCEDURE WAS RESCHEDULED FOR ONE WEEK LATER, FOR RETRIEVAL OF THE MARKER. ON THAT DAY, THE PT UNDERWENT A CONTRAST TEST. THE RO MARKER WAS NOT FOUND. THE PHYSICIAN INDICATED THAT THE RO MARKER HAD MOST LIKELY BEEN ELIMINATED VIA NORMAL PERISTALSIS. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEM RX CANNULA NML BOSTON SCIENTIFIC CORPORATION M00545820 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other