BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUINTON

    MDR report key: 99260 · Received June 17, 1997

    Report

    Report Number
    99260
    Event Type
    Injury
    Date Received
    June 17, 1997
    Date of Event
    June 10, 1997
    Report Date
    June 12, 1997
    Manufacturer
    QUINTON INSTRUMENT CO
    Product Code
    LFK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS SENT TO THE HOSP FOR ACUTE RENAL FAILURE. UNDERWENT A PERM CATHETER INSERTION ON 6/10/97 FOR START OF DIALYSIS. UNDER LOCAL ANESTHETIC, THE RIGHT INTERNAL JUGULAR VEIN WAS ACCESSED. 4 12 FRENCH DIALATOR WAS PLACED INTO SUPERIOR VENA CAVA AND THEN A 14 FRENCH PEEL-AWAY SHEATH WAS PLACED, FOLLOWED BY THE DIALYSIS CATHETER. SOME DIFFICULTY WAS ENCOUNTERED WITH REMOVAL OF THE PEEL-WAY SHEATH. FOLLOW UP CHEST XRAY NOTED A SMALL SEGMENT OF THE SHEATH WAS SEEN IN THE THE SOFT TISSUE AT THE NECK AND RIGHT INTERNAL JUGULAR VEIN. ON 6/12/97 PT HAD THE RETAINED PIECE MANIPULATED TO THE RIGHT FEMORAL ARTERY WHERE IT WAS REMOVED VIA VENOUS CUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUINTON Implant DIALYSIS CATHETER LFK QUINTON INSTRUMENT CO REF #17749-001 800789-1997 03

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention