BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 3223803 · Received July 10, 2013

    Report

    Report Number
    2522007-2013-00019
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    July 9, 2013
    Manufacturer
    COOK VASCULAR INC.
    Product Code
    DWF
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE LENGTH OF CATHETER (38CM), ONE CATHETER LOCK, AND ONE VITAL PORT WERE RETURNED TO THE MFR. THE CATHETER AND CATHETER LOCK WERE NOT CONNECTED TO THE VITAL PORT WHEN RECEIVED BY CVI. IT WAS NOTED THAT LEAKAGE WAS NOTED 5CM FROM THE END OF THE CATHETER. THE DIMENSIONS OF THE RETURNED COMPONENTS WERE MEASURED AND FOUND TO BE WITHIN MFG SPECIFICATIONS. A VISUAL INSPECTION OF THE CATHETER SHOWED NO APPARENT SIGNS OF BRUISING OR BURNING. THEREFORE, THE CATHETER DID NOT EXHIBIT ANY SIGNS OF A PROPER CONNECTION TO THE PORT. THERE IS NO EVIDENCE THAT THE CATHETER WAS ADVANCED OVER THE RING OF THE OUTLET TUBE BEFORE THE CATHETER LOCK WAS ADVANCED. THIS IS NOT THE PROPER METHOD OF ASSEMBLING THE VITAL-PORT SYSTEM AND CAN RESULT IN A CATHETER DISCONNECT. IT IS SUGGESTED THAT THE USER REVIEW THE SUGGESTED INSTRUCTIONS FOR USE THAT IS SUPPLIED WITH THE DEVICE AND REVIEW "SECTION ASSEMBLY" ALONG WITH FIGURES 6 AND 7.

    Description of Event or Problem · 1

    COOK (B)(6) REPORTED FOR THE CUSTOMER, "DATE UNK: THE PORT WAS IMPLANTED IN THE UPPER ARM. THE PHYSICIAN PUNCTURED THE BASILIC VEIN AND PLACED THE CATHETER. THE PHYSICIAN TOLD THE REP THAT HE SLID THE LOCKING SLEEVE TO WHERE HE HEARD 'CLICK' SOUND. HE PERFORMED HEPARIN LOCK AND COMPLETED THE PROCEDURE. DURING ESOPHAGUS FLUOROSCOPY THREE DAYS AFTER PLACEMENT, DETACHMENT OF THE CATHETER FROM THE PORT AND ITS MIGRATION TO THE RIGHT ATRIUM WERE CONFIRMED. THE PHYSICIAN CONFIRMED THE LOCKING SLEEVE WAS ATTACHED TO THE PORT. DATE UNK: THE PORT AND THE CATHETER WERE REMOVED. THE CATHETER WAS REMOVED PERCUTANEOUSLY FROM THE PATIENT SUCCESSFULLY USING A CATHETER FOR INTRAVASCULAR SURGERY BY A PHYSICIAN OF RADIOLOGY. ADD'L INFO: (B)(6) 2013: "ABOUT REMOVAL OF THE CATHETER, I JUST HAVE NOTIFIED AS 'THE CATHETER WAS REMOVED PERCUTANEOUSLY USING A 'CATHETER FOR INTRAVASCULAR SURGERY'. I ADDED IT IN DESCRIPTION OF EVENT." THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316022 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER DWF COOK VASCULAR INC. IP-S5116-N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention