BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 2-LUMEN 8 FR X 16 CM

    MDR report key: 1983885 · Received February 4, 2011

    Report

    Report Number
    1036844-2011-00048
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING PLACED BY THE PHYSICIAN IN THE RIGHT INTERNAL JUGULAR (IJ). THE IJ WAS CANNULATED EASILY WITH THE STEAL BORE NEEDLE. THE SPRING WIRE GUIDE (SWG) WAS THREADED WITH MILD RESISTANCE. BECAUSE OF INITIAL RESISTANCE, THE SWG WAS WITHDRAWN INTO ITS CIRCULAR SHEATH; THERE WERE NO ABNORMALITIES TO SUGGEST ANY DEFECTS AT THIS TIME. THE INTRODUCER NEEDLE WAS REMOVED AND A SECOND PASS AT THE VEIN WAS EASILY CANNULATED, THE SWG PASSED VERY EASILY. THREE ATTEMPTS WERE MADE WITH THE DILATOR AND ON THE THIRD ATTEMPT, THE DILATOR EASILY PASSED. THE CATHETER WAS EASILY THREADED AND THE SWG WAS PULLED OUT. WHEN THE SWG WAS PULLED OUT THEY NOTICED THAT THE J-PORTION OF THE SWG HAD UNRAVELED. A CXR (CHEST X-RAY) WAS IMMEDIATELY OPENED. IT APPEARED THAT 2 CM OF SWG HAD STRETCHED INTO APPROXIMATELY 2 FEET OF UNCOILED SWG AND THERE WAS VERY LOW SUSPICION OF ANY MISSING PIECE. WHEN THE ANESTHESIOLOGIST AND SURGEON REVIEWED THE CXR, NOTHING ABNORMAL WAS NOTED AND THE CASE WAS ALLOWED TO PROCEED. TO SEE IF UNRAVELED SWG HAD OCCURRED, AN INTERVENTIONAL RADIOLOGIST WAS "CURB-CONSULTED." HE NOTICED THE MISSING FRAGMENT AT THE SUPERIOR PORTION OF THE CVC (WITHIN THE LUMEN OF THE CVC). AT THAT POINT, APPROXIMATELY 500ML OF SALINE HAD INFUSED THROUGH THE LINE. THIS WAS IMMEDIATELY DISCONTINUED AND A SECOND CXR AND NECK X-RAY WAS OBTAINED, WHICH DID NOT SHOW THE MISSING PIECE, IMPLYING EMBOLIZATION. LATER, AFTER THE SURGERY CONCLUDED, THE PATIENT WAS TAKEN FOR A CHEST CT AND THE FRAGMENT WAS SHOWN TO BE BETWEEN THE RIGHT ATRIUM AND VENTRICLE. THE IR TEAM WAS CALLED AND THEY WERE ABLE TO SUCCESSFULLY RETRIEVE THE MISSING FRAGMENT. THE PT RECOVERED UNEVENTFULLY. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 8 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL, INC RF0103477

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention