BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 38648 · Received September 17, 1996

    Report

    Report Number
    1219454-1996-00411
    Event Type
    Injury
    Date Received
    September 17, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 17, 1996
    Manufacturer
    STRATO/INFUSAID INC
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/01/96, A MFR REP CONTACTED THE FACILITY'S RISK MANAGER. THE FACILITY'S RISK MANAGER STATED THAT THE DEVICE AND PORTION OF THE DEVICE CATHETER THAT WAS REMOVED AT HER FACILITY AND SENT ALONG WITH THE PATIENT TO THE OTHER FACILITY WHEN THE PATIENT WAS TRANSFERRED FOR REMOVAL OF THE REMAINING SEGMENT OF CATHETER HAD SOMEHOW BEEN LOST/MISPLACED. THE FACILITY'S RISK MANAGER ALSO STATED THAT SHE REQUESTED THE OTHER FACILITY SEND A WRITTEN REPORT TO HER EXPLAINING THE LOSS/MISPLACEMENT OF THE DEVICE AND PORTION OF DEVICE CATHETER. THE MFR REP REQUESTED A COPY OF THIS REPORT WHEN RECEIVED. THE ONLY THING THAT WAS RETURNED TO HER FACILITY WAS THE BLUE SEGMENT OF CATHETER THE OTHER FACILITY REMOVED, APPROXIMATELY 4-5" IN LENGTH AND SHE WAS NOT SURE THAT THIS WOULD BE ENOUGH TO PERFORM AN ANALYSIS ON. THE MFR REP REQUESTED THAT THE SEGMENT OF BLUE CATHETER BE RETURNED TO THE MFR FOR ANALYSIS. THE DEVICE WAS RETURNED ON 10/7/96, AND IS PRESENTLY UNDERGOING ANALYSIS. NO FURTHER DETAILS ARE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ON 8/20/96, THE FACILITY'S OR MANAGER CONTACTED A MFR CUSTOMER SVC REP AND STATED THAT THEY WERE UNABLE TO ACCESS THE DEVICE AND AS A RESULT, THE SURGEON DECIDED TO EXPLANT THE DEVICE. THE FACILITY'S OR MANAGER ADDITIONALLY STATED THAT WHEN THE SURGEON WENT TO PULL OUT THE DEVICE CATHETER, THE CATHETER SHEARED. THREE(3) OR FOUR (4) INCHES OF THE DEVICE CATHETER REMAINED IMPLANTED IN THE PT. THE PT WAS THEN TRANSFERRED TO ANOTHER FACILITY TO COMPLETE THE EXPLANT OF THE REMAINING DEVICE CATHETER. THE PORTION OF THE DEVICE CATHETER AND THE DEVICE THAT WERE REMOVED WERE SENT ALONG WITH THE PT TO THE OTHER FACILITY. THE FACILITY'S OR MANAGER REQUESTED THAT ALL THE PIECES BE RETURNED TO BE EVALUATED BY THEIR LAB, AFTER WHICH, THE FACILITY WILL RETURN THE DEVICE AND THE PORTIONS OF THE DEVICE CATHETER TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPORT VASCULAR ACCESS SYSTEM Implant VASCULAR ACCESS DEVICE LJT STRATO/INFUSAID INC NA 430503

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention