BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TLAH 19G X 60CM FLEX TIP

    MDR report key: 4939600 · Received July 22, 2015

    Report

    Report Number
    1625425-2015-00023
    Event Type
    Injury
    Date Received
    July 22, 2015
    Report Date
    July 21, 2015
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    DYB
    PMA / PMN Number
    K22634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADIO-OPAQUE TIP FRACTURED OFF FROM THE CATHETER IN THE RIGHT HEPATIC VEIN. PER THE DOCTOR, HE TRAPPED IT IN THE RIGHT HEPATIC VEIN BUT DURING THE FIRST RETRIEVAL ATTEMPT IT RAPIDLY MIGRATED THROUGH THE RIGHT HEART AND INTO A BRANCH OF THE RIGHT PULMONARY ARTERY. THE DOCTOR WAS ABLE TO RETRIEVE THE FRAGMENT FROM THERE RATHER QUICKLY WITH NO COMPLICATIONS OR INJURY TO THE PT. THE ACTUAL ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE ACTUAL COMPLAINT LOT WAS NOT AVAILABLE FOR EVAL. IT WAS DETERMINED THAT THE LOT WAS PROBABLY EITHER HU8F OR J082 BASED ON THE LOT NUMBERS SHIPPED TO THE HOSPITAL. THE BATCH RECORDS FOR THE LOTS THAT WENT INTO THE FINISHED LEVEL LOTS HU8F AND J082 WERE REVIEWED AND THERE WERE NO DEVIATIONS, NONCONFORMANCES, OR ANOMALIES NOTED. A SCAR WAS ISSUED TO SUPPLIER ON 02/24/2015 FOR A SIMILAR COMPLAINT BUT DIFFERENT LOT FROM THE COMPLAINT LOT. POSSIBLE ROOT CAUSES AND CORRECTIVE ACTIONS WERE IDENTIFIED IN THE SCAR REPORT WHICH WAS SIGNED OFF ON 03/06/2015. LOTS HU8F AND J082 WERE MANUFACTURED PRIOR TO 03/06/2015. NO OTHER SIMILAR COMPLAINTS HAVE BEEN RECEIVED SINCE IMPLEMENTATION OF THE CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    THE MPA WAS INSERTED THROUGH THE BIOPSY SHEATH. ONCE THIS WAS DONE, THE RADIOPAQUE TIP FELL OFF IN THE HEPATIC VEIN. MEDICAL INTERVENTION WAS THEN USED TO RETRIEVE THE TIP WITH A SNARE. A SECOND DEVICE WAS OPENED, AND IT WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475504 TLAH 19G X 60CM FLEX TIP TLAB DYB ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention