BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 155328 · Received March 10, 1998

    Report

    Report Number
    1220923-1998-00015
    Event Type
    Injury
    Date Received
    March 10, 1998
    Date of Event
    November 15, 1997
    Report Date
    December 9, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    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

    ON 2/9/1998, THE MFR REC'D MEDWATCH REPORT #1900480000-1997-0001 FROM THE FACILITY'S NURSE THAT STATES THE FOLLOWING: THE DEVICE WAS IMPLANTED ON 3/11/97. ON 11/15/97, THE PT WAS ADMITTED TO THE HOSPITAL. A CHEST X-RAY WAS DONE ON 11/17/97, WHICH REVEALED THAT THE CATHETER COMPONENT OF THE DEVICE HAD BECOME DETACHED FROM THE DEVICE AND ENTIRETY OF THE CATHETER APPEARED TO BE LODGED IN THE SUPERIOR VENA CAVA. THE PT HAD A PREVIOUS X-RAY DONE ON 10/18/97, WHICH DID NOT REVEAL THE ABOVE. THE PT WAS DISCHARGED FROM THIS FACILITY ON 12/5/97, AND WILL BE SEEN IN THE CLINIC BY A SURGEON WHO WILL SCHEDULE REMOVAL OF THIS CATHETER AT ANOTHER FACILITY SOMETIME IN DECEMBER 1997. NO FURTHER DETAILS WERE PROVIDED AT THIS 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 13865

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention