BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENT TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT

    MDR report key: 8575389 · Received May 2, 2019

    Report

    Report Number
    1649395-2019-00004
    Event Type
    Injury
    Date Received
    May 2, 2019
    Date of Event
    February 9, 2019
    Report Date
    February 19, 2019
    Manufacturer
    GALT MEDICAL CORPORATION
    Product Code
    DQX
    UDI-DI
    10841268104584
    PMA / PMN Number
    K021990
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS HAVE BEEN REVIEWED FOR MAIN PRODUCT AND SUBCOMPONENTS AND THERE WERE NO INCIDENTS OR ABNORMALITY INDICATED. ALL PARTS HAVE BEEN MANUFACTURED ACCORDING TO GALT INTERNAL DRAWING SPECIFICATIONS. ONE SAMPLE WAS RETURNED AND THE COMPLAINT WAS CONFIRMED. GALT TOOK SOME PHOTOS FOR RETURNED SAMPLE, IMAGES SHOWS NO DAMAGE OCCURRENCE TO THE DISTAL TIP AFTER RETRIEVED FROM PATIENT; BALL WELD FINISHING WAS PROPERLY DONE. ADDITIONAL IMAGES SHOW LOOSENS EXACTLY AFTER THE DISTAL TIP PORTION, VARIOUS ANGLES OF MANDREL PORTION TOWARDS PROXIMAL WAS CUT OFF AND MANDREL HAS BEEN TWISTED DUE TO OVER TORQUE AND USING WRONG ANGLE DURING INSERTION OR RETRIEVING THE WIRE FROM PATIENT THAT MEANS UNIT WAS SUBMITTED TO EXCESSIVE FORCE. OTHER IMAGES SHOW THE REMAINDER OF MANDREL CUTTING PORTION TOWARDS DISTAL COILED AND DISCOLORATION OCCURRENCE TO THE MANDREL DUE TO USING TORQUE FORCE. ACCORDING TO END USER REPORT "THE WIRE WAS PLACED AND THE CATHETER WAS ADVANCED OVER THE WIRE, THE CATHETER WAS THEN REMOVED AND A PEEL AWAY SHEATH PLACED DURING A REPEAT ACCESS IT WAS NOTED THE FLOPPY END OF THE WIRE HAD BEEN FRACTURED. USING ULTRASOUND AND A GOOSENECK SNARE DEVICE, THE FLOPPY END OF THE WIRE WAS REMOVED IN ITS ENTIRETY". BASED ON INVESTIGATION AND EVALUATIONS THIS WAS DETERMINED TO BE END USER ERROR (END USER DIDN'T FOLLOW IFU). RECOMMENDATIONS WERE MADE TO END USER TO ADHERE TO INSTRUCTION FOR USE THAT SHIPPED ALONG WITH EACH SINGLE KIT UNDER (LAB-021-00K).

    Description of Event or Problem · 1

    AS RECEIVED FROM END USER TO MANUFACTURER: THE PATIENT REQUIRED A CHEST PORT FOR CHEMOTHERAPY. WHEN PLACING PORT UNDER FLUOROSCOPY, THE RIGHT INTERNAL JUGULAR WAS IDENTIFIED. THE WIRE WAS PLACED AND THE CATHETER WAS ADVANCED OVER THE WIRE, THE CATHETER WAS THEN REMOVED AND A PEEL AWAY SHEATH PLACED DURING A REPEAT ACCESS IT WAS NOTED THE FLOPPY END OF THE WIRE HAD BEEN FRACTURED. USING ULTRASOUND AND A GOOSENECK SNARE DEVICE, THE FLOPPY END OF THE WIRE WAS REMOVED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366418 FLUENT TRANSITIONLESS STIFFEN MICRO-INTRODUCER KIT FLUENT STIFFEN MICRO-INTRODUCER KIT DQX GALT MEDICAL CORPORATION KIT-039-03 G18278173 10841268104584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other