BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT

    MDR report key: 2821038 · Received October 26, 2012

    Report

    Report Number
    2522007-2012-00023
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    June 11, 2012
    Report Date
    October 18, 2012
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    PMA / PMN Number
    K931586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ENGINEERING REPORTED, "A MINI PORT BODY AND CATHETER LOCK WERE RETURNED FOR EVALUATION. ONE SUTURE HOLE HAD BEEN USED. BOTH THE PORT BODY AND LOCK WERE DIMENSIONALLY CHARACTERIZED AND FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS." ENGINEERING STATED, "A FULL INVESTIGATION CANNOT BE COMPLETED WITHOUT THE CATHETER. THERE WERE NO DEFECTS FOUND IN THE RETURNED COMPONENTS." "IT IS SUGGESTED THE USER REVIEW THE SECTION "SYSTEM ASSEMBLY" IN THE SUGGESTED INSTRUCTIONS FOR USE."

    Description of Event or Problem · 1

    COOK (B)(4) REPORTED FOR THE CUSTOMER. "THERE WAS A PROBLEM WITH A MINI PORT BECOMING DETACHED." PER COMPLAINT FORM: PORT BECAME DETACHED FORM THE PT. MINI PORT DETACHED INSERTED PERIPHERALLY INTO THE ARM. PORT BECAME DISLODGED FROM THE CATHETER. THE CATHETER THEN ENDED UP IN THE PT'S HEART. EMERGENCY RETRIEVAL DONE BY CARDIOLOGIST AND THE CATHETER REMOVED SUCCESSFUL. COMPLAINT FORM RECEIVED AND ATTACHED. THE CATHETER MIGRATED TO HEART AND WAS RETRIEVED BY FORCEPS. I HAVE REQUESTED INFORMATION ON PT CONDITION AND INFORMATION OF ADVERSE EFFECTS." NO SECTION OF THE DEVICE REMAINED IN THE PT OR HAD TO BE RETRIEVED. REMOVAL OF CATHETER BY CARDIOLOGIST WITH THE AID OF VASCULAR RETRIEVAL FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER LJT COOK VASCULAR INC IP-S5116W-MPIS-NT N102459

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention