BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 133371 · Received November 19, 1997

    Report

    Report Number
    1220923-1997-00030
    Event Type
    Injury
    Date Received
    November 19, 1997
    Date of Event
    October 1, 1997
    Report Date
    October 20, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 THE RESULTS OF THE MFR'S INVESTIGATION AND ANALYSIS OF THE DEVICE, ANATOMICALLY INDUCED REPETITIVE CLAVICULAR COMPRESSION APPEARS TO HAVE CAUSED THE DAMAGE FOUND DURING THE MFR'S ANALYSIS/INVESTIGATION OF THE DEVICE. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT. MDR#1219454-1997-00223, MDR#1220923-1997-00030, MDR#1220923-1997-00221, AND MDR#1220923-1997-00040. SUBMITTED TO THE FDA 1/26/99.

    Description of Event or Problem · 1

    ON 10/20/1997, THE FACILITY'S INVENTORY CONTROL DEPARTMENT INFORMED THE MANUFACTURER'S SALES REPRESENTATIVE THAT THE DEVICE CATHETER HAD SHEARED (DATE NOT SPECIFIED) AND AS A RESULT THE DEVICE WAS SCHEDULED TO BE EXPLANTED ON 10/24/1997. 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 13790

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention