BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE

    MDR report key: 6061610 · Received October 27, 2016

    Report

    Report Number
    1820334-2016-01148
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    September 30, 2016
    Report Date
    April 12, 2017
    Manufacturer
    COOK INC
    Product Code
    FCG
    UDI-DI
    00827002082861
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED/DAMAGED TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE WAS RETURNED FOR INVESTIGATION WITH THE GUIDING CANNULA INSERTED THROUGH THE SHEATH. THE SHEATH TUBING MATERIAL WAS FOUND TO PROTRUDE APPROXIMATELY 1 CM FROM THE DISTAL END OF THE SHEATH. THE TUBING MATERIAL REMAINED INTACT (NO OBSERVED TEARS) AND DISCOLORATION WAS OBSERVED DUE TO THE MATERIAL STRETCHING. THE DISTAL TIP OF THE INSERTED GUIDING CANNULA WAS LOCATED AT THE OBSERVED PROTUBERANCE. IT IS LIKELY THAT DURING ADVANCEMENT OF THE DEVICE, THE DISTAL END OF THE GUIDING CANNULA HAD INADVERTENTLY BEEN PUSHED INTO THE SHEATH TUBING MATERIAL, THUS CAUSING THE OBSERVED DAMAGE. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED DEVICE AND THE RESULTS OF OUR INVESTIGATION, IT IS FEASIBLE TO SUGGEST THE ROOT CAUSE OF THE OBSERVED DAMAGE TO THE SHEATH CAN BE ATTRIBUTED TO THE EXTENDED SHEATH LENGTH DUE TO MANUFACTURING OPERATOR ERROR. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TRANSJUGULAR BIOPSY (BX) PROCEDURE THE 7FR SHEATH FRACTURED AT THE DISTAL TIP WHILE GAINING ACCESS THROUGH THE RIGHT HEPATIC VEIN IN THE LIVER OF A TORTUOUS ANATOMY. (180334-2016-01148). THE FRACTURE OF THE SHEATH LED TO BOTH THE MEMORY POLYP BASKETS (MPB) AND ANOTHER MANUFACTURERS GLIDE CATHETER DISTAL TIPS BEING SHEARED OFF AND REMAINING IN THE PATIENT, THE GLIDE CATHETER WAS RETRIEVED USING A SNARE. THE COOK MPB WAS LOCATED IN THE PULMONARY ARTERY AND UNABLE TO BE RETRIEVED. (1820334-2016-01149).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712505 TRANSJUGULAR LIVER ACCESS AND BIOPSY NEEDLE FCG KIT, NEEDLE, BIOPSY FCG COOK INC N/A 00827002082861

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention