BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPORT VASCULAR ACCESS SYSTEM

    MDR report key: 137659 · Received December 11, 1997

    Report

    Report Number
    1220923-1997-00040
    Event Type
    Injury
    Date Received
    December 11, 1997
    Date of Event
    September 18, 1997
    Report Date
    November 14, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LJT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 11/14/97, THE DISTRIBUTOR'S SALES REPRESENTATIVE INFORMED THE MFR'S (MFR) REPRESENTATIVE VIA TELEPHONE AND FAXED REPORTS THAT A CUSTOMER IN HER TERRITORY HAD EXPERIENCED THREE (3) PROBLEMS WITH THIS DEVICE. THIS REPORT CONCERNS THE THIRD EVENT. THE REPORT STATES THE FOLLOWING: ON 9/18/97, THE DEVICE WAS ACCESSED AND SWELLING WAS NOTICED ABOVE THE DEVICE. THE PT COMPLAINED OF PAIN AND THE PHYSICIAN WAS NOTIFIED. A CHEST X-RAY (DATE NOT SPECIFIED) SHOWED THAT THE CATHETER FRACTURED. TWO (2) SPECIAL PROCEDURES, DEVICE REMOVED ON 9/19/97. 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 UNKNOWN Required Intervention