BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIUMPH-1 PORT

    MDR report key: 221329 · Received May 3, 1999

    Report

    Report Number
    1056436-1999-00079
    Event Type
    Injury
    Date Received
    May 3, 1999
    Date of Event
    April 6, 1999
    Manufacturer
    HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    ON 4/7/1999, THE FACILITY'S OR. NURSE MANAGER INFORMED THE MFR (MFR.) SALES REP OF THE FOLLOWING: INITIALLY, THE DEVICE PERFORMED ADEQUATELY. OVER THE LAST WEEK PROBLEMS HAVE ACCOMPANIED INFUSION. THE PT COULD FEEL THE MEDICATION INFUSING INTO HER CHEST. A DYE STUDY WAS PERFORMED CONFIRMING THAT THE DISTAL PORTION OF THE CATHETER HAD BEEN SEVERED. THE DR ASSUMED THAT THIS WAS DONE BY THE CLAVICLE AND FIRST RIB PINCHING THE CATHETER. THE DISTAL PORTION OF THE CATHETER MIGRATED TO THE LEFT PULMONARY ARTERY. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME. ON 4/13/1999M THE MFR. RECEIVED MEDWATCH REPORT# 210039-1999-0001 VIA FAX THAT STATES THE FOLLOWING: DEVICE IMPLANTED 2/3/1999. RIGHT SUBCLAVIAN UNDER LOCAL ANESTHESIA. CHEMOTHERAPY WAS STATED TO HAVE BEGUN 2/5/1999. RECORD REFERS TO DIFFICULTY IN ACCESS TO DEVICE. X-RAY SHOWED FRACTURE OF CATHETER. DISTAL PORTION MIGRATED TO THE LEFT INFERIOR PULMONARY ARTERY. ON 4/6/1999, REMOVAL OF RIGHT VENOUS ACCESS DEVICE PERFORMED AND IMPLANT OF NEW DEVICE, LEFT. THE MEDWATCH REPORT ALSO STATED THAT THE DEVICE IN QUESTION WAS AVAILABLE TO BE RETURNED TO THE MFR. FOR ANALYSIS. HOWEVER, ON 4/19/1999, THE MFR. WAS INFORMED VIA A FAXED LETTER FROM THE MFR.'S SALES REP OF THE FOLLOWING: THIS IS TO MAKE THE MFR. AWARE THAT THE FACILITY WILL NOT AT THIS TIME RETURN THE DEVICE IN QUESTION. THE OR, NURSE MANAGER INFORMED THE MFR.'S SALES REP THAT THE HOSP WILL NOT RELINQUISH THE DEVICE AT THIS TIME BECAUSE THE PT'S LAWYER HAS REQUESTED THE DEVICE. THE HOSP HAS NOT COME TO A CONCLUSION AT THIS TIME ON WHETHER OR NOT TO RELEASE THE PRODUCT TO THE MFR. OR THE PT'S LAWYER. THE MFR.'S SALES REP WILL BE NOTIFIED WHEN A DECISION IS MADE. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIUMPH-1 PORT VASCULAR ACCESS PORT LJT HORIZON MEDICAL PRODUCTS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R