BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2017 NAVICATH KIT

    MDR report key: 3593758 · Received December 30, 2013

    Report

    Report Number
    1062474-2013-00002
    Event Type
    Injury
    Date Received
    December 30, 2013
    Date of Event
    October 29, 2013
    Report Date
    December 9, 2013
    Manufacturer
    MYELOTEC, INC.
    Product Code
    HRX
    PMA / PMN Number
    K980734
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT BULK SHEATH COMPONENT THAT IS CONTRACT MANUFACTURED BY AN APPROVED SUPPLIER AND USED AS A COMPONENT IN MYELOTEC'S 2017 NAVICATH KIT THAT CONTAINS A CATHETER AND INTRODUCER SHEATH, GUIDEWIRE, AND TUOHY NEEDLE WHICH ARE USED AS ACCESSORIES FOR ENTRY OF THE CATHETER'S LUMEN USED FOR DRUG DELIVERY. IT WAS REPORTED FROM THE USER FACILITY - (B)(6) - THAT THE DISTAL END OF THE INTRODUCER SHEATH BROKE OFF INSIDE PATIENT AND WAS RETRIEVED WITH A HEMOSTAT. CONDITION OF THE PATIENT FOLLOWING REMOVAL WAS REPORTED BY (B)(6) TO BE FINE. THE BROKEN DEVICE WAS RETURNED TO MYELOTEC, INC., MANUFACTURER OF THE 2017 NAVICATH KIT, THAT THE SHEATH IS AN ACCESSORY COMPONENT. MYELOTEC'S INITIAL EVALUATION INVOLVED A REVIEW OF THE INCOMING INSPECTION RECORDS FOR THE SHEATH THAT WAS TRACED BY LOT NUMBER OF THE FINISHED PRODUCT KIT, A REVIEW OF THE DEVICE HISTORY RECORD, AND VISUAL INSPECTION OF ONE OF THE RETAIN SAMPLES FROM THE SAME LOT. AN AQL OF 2.5 LEVEL 1 SAMPLING REVEALED NO UNACCEPTABLE SHEATHS ACCORDING TO PREDETERMINED CRITERIA. ENHANCED PHOTOGRAPHS WERE TAKEN. THE COMPONENT SHEATH WAS THEN RETURNED TO THE CONTRACT MANUFACTURER FOR FURTHER EVALUATION. THE ONE SAMPLE THAT WAS RETURNED FROM THE CONTRACT MANUFACTURER WAS VISUALLY EXAMINED AND FOUND TO HAVE THE TUBING PULLED OUT OF THE HANDLE AS EVIDENCED BY ENHANCED PHOTOGRAPHS. DIMENSIONAL ID AND OD OF THE RETURNED SHEATH WAS WITHIN INSPECTION CRITERIA. THE LENGTH COULD NOT BE ACCURATELY MEASURED DUE TO THE DAMAGED DETACHMENT. THE PRODUCTION LOT OF THE RETURNED COMPONENT WAS REVIEWED FOR ANY ABNORMALITIES THAT MAY HAVE CAUSED THE SHEATH TO DETACH AND NO DISCREPANCIES WERE NOTED. AN UNDAMAGED SAMPLE FROM THE SAME LOT WAS PULLED BY MYELOTEC AND SENT FOR COMPARATIVE TESTING BY THE CONTRACT SUPPLIER; THERE WERE NO VISUAL, OR DIMENSIONAL DISCREPANCIES, HISTORICAL RECORDS THAT REVEALED UNACCEPTABLE CONDITIONS NOTED IN WORK ORDERS AND/OR MANUFACTURING FOR THE LOT. THE SUPPLIER ALSO REVIEWED COMPLAINT RECORDS THAT REVEALED THAT THIS WAS THE FIRST REPORT OF THIS NATURE FOR HUB DETACHMENT FOR THIS COMPONENT. COMPLAINT RATIO OF SIMILAR COMPLAINTS WAS (B)(4). THE ROOT CAUSE APPEARS TO BE DUE TO EXCESSIVE FORCE ON THE INTRODUCER SHEATH DURING USE CAUSING THE TUBE TO BREAK OFF/TEAR INSIDE THE HANDLE.

    Description of Event or Problem · 1

    DISTAL PORTION OF WHITE INTRODUCER SHEATH SHEARED OFF IN PATIENT DURING USE AND INTERVENTION WAS PERFORMED BY USE OF A HEMOSTAT TO REMOVE THE SHEARED OFF PORTION. CURRENT STATUS OF THE PATIENT IS FINE FOLLOWING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680606 2017 NAVICATH KIT CATHETER W/ACCESS COMPONENTS HRX MYELOTEC, INC. NA 3672 / MY31912

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention