BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 125982 · Received October 10, 1997

    Report

    Report Number
    1220923-1997-00008
    Event Type
    Injury
    Date Received
    October 10, 1997
    Date of Event
    September 5, 1997
    Report Date
    September 11, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    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 9/23/97, THE FACILITY'S RISK MANAGER'S ASSITANT CONTACTED THE MFR'S REP AND STATED THAT SHE WANTED TO SEND A MEDWATCH REPORT TO THE MFR; HOWEVER, SHE WAS INFORMED THAT THE MFR NO LONGER WAS AT THEIR FORMER ADDRESS. THE MFR'S REP INFORMED THE FACILITY'S RISK MANAGER'S ASSISTANT OF THE MFR'S ADDRESS, TELEPHONE, FAX NUMBERS, NAME AND ADDRESS OF THE MFR'S NEW OWNERS. THE FACILITY'S RISK MANAGER'S ASSISTANT FAXED THE MEDWATCH REPORT IMMEDIATELY (9/23/97) WHICH STATES THE FOLLOWING: 9/1/97, INTRAVASCULAR ACCESS DEVICE (IVAD) PLACED IN SUPERIOR VENA CAVA. 9/5/97, FLUOROSCOPY SHOWED EXTRAVASATION FROM THE DEVICE (IVAD). 9/9/97, THE PT WAS SENT TO THE OR FOR REVISION OF THE DEVICE (IVAD). 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 13706

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention