BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 137127 · Received December 9, 1997

    Report

    Report Number
    1220923-1997-00036
    Event Type
    Injury
    Date Received
    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
    NY, 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 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#1219454-1997-00219, MDR#1219454-1997-00222, MDR#1219454-1997-00250, MDR#1219454-1997-00252, MDR#1220923-1997-00036, MDR#1220923-1998-00063, MDR#1219454-1997-00248, MDR#1219454-1997-00251, MDR#1219454-1997-00332, MDR#1220923-1998-00016.

    Description of Event or Problem · 1

    THE FACILITY'S ASSISTANT VICE PRESIDENT, RISK MANAGEMENT STATED THAT THE PT WAS DUE TO BE TRANSFERRED TO ANOTHER FACILITY LATER IN THE DAY TO HAVE THE DEVICE AND SEGMENT OF THE DEVICE CATHETER WHICH MIGRATED TO THE RIGHT VENTRICLE REMOVED. THE MFR'S REP REQUESTED A COPY OF THE FACILITY'S MEDWATCH REPORT BE FAXED TO THE MFR. THE MFR'S REP ALSO ASKED IF THE DEVICE WOULD BE RETURNED TO THE MFR FOR ANALYSIS. THE FACILITY'S ASSISTANT VICE PRESIDENT, RISK MANAGEMENT STATED THAT THE MFR'S REP WOULD HAVE TO CONTACT THE EXPLANTING FACILITY FOR THAT INFO. 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 13913

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention