BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 104802 · Received July 11, 1997

    Report

    Report Number
    1219454-1997-00294
    Event Type
    Injury
    Date Received
    July 11, 1997
    Date of Event
    May 13, 1997
    Report Date
    June 16, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION RESULTS OF APPARENT TREND FOR SUSPECTED CATHETER LOT HAS BEEN COMPLETED AND THE RESULTS ARE AS FOLLOWS: 1) THE COMPLAINT RATE WAS CONSISTENT WITH COMPLAINT RATES FROM OTHER MFG LOTS. 2) THE PRODUCT PROFILE WAS BIMODAL, BUT BOTH ARMS OF THE MODALITY WERE WITHIN THE PRODUCT SPEC. 3) MATERIAL ID AND FUNCTION WERE CONSISTENT WITH 510K AND COMPANY SPECS. 4) SHEARED CATHETERS RETURNED WERE REVIEWED AND FOUND TO HAVE THE "PINCH-OFF" INDICATION. THE COMPLETE FILE OF THIS APPARENT TREND WAS REVIEWED BY A FOOD AND DRUG ADMINISTRATION INVESTIGATOR DURING AN ATLANTA DISTRICT OFFICE AUDIT CONDUCTED FROM 8/24/98 THROUGH 9/15/98. BASED ON THE INFO AVAILABLE AND DUE TO THE UNAVAILABILITY OF THE DEVICE, NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. MDR#1220923-1997-00294, MDR#1220923-1997-00008 AND MDR#1220923-1998-00015. SUBMITTED TO THE FDA 1/22/99.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 11/12/96 FOR INFUSION OF PLATINUM AND FLUORO. ON 06/16/97, THE MANUFACTURER RECEIVED A REPORT FROM ITS ITALIAN DISTRIBUTOR DETAILING AN INCIDENT WHICH HAD OCCURRED AT A FACILITY IN THEIR TERRITORY. THE REPORT, WHICH WAS MADE BY THE SURGEON, STATES THAT THERE WAS "COMPLETE CATHETER DETACHMENT". THE DEVICE CATHETER WAS "FREE IN THE BLOOD STREAM AND THEN STUCK IN THE ATRIUM". NO FURTHER DETAILS WERE PROVIDED AT THAT TIME.

    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 13595

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention