BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 157825 · Received March 19, 1998

    Report

    Report Number
    1220923-1998-00016
    Event Type
    Injury
    Date Received
    March 19, 1998
    Date of Event
    January 27, 1998
    Report Date
    February 17, 1998
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    ON 2/17/1998, THE MFR REC'D INFO VIA FAX FROM ITS INTERNATIONAL DISTRIBUTOR REGARDING A FACILITY IN THEIR TERRITORY. THE REPORT STATES THE FOLLOWING: THE INTERNATIONAL DISTRIBUTOR REC'D THE DEVICE WHICH BROKE. ALSO INCLUDED WAS THE FACILITY'S REPORT THAT WAS SENT TO THE DISTRIBUTOR; HOWEVER, THE REPORT WAS WRITTEN IN FRENCH. THE MFR'S REP WAS ABLE TO TRANSLATE PART OF THE REPORT WHICH APPEARS TO STATE THAT ON 1/27/1998, IT WAS NOTED THAT THE DEVICE CATHETER RUPTURED AND AS A RESULT THE DEVICE WAS EXPLANTED ON 1/28/1998; HOWEVER, THAT IS ALL THAT COULD BE DETERMINED AT THIS TIME. 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 UNKNOWN Required Intervention