BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL / VAXCEL

    MDR report key: 2142366 · Received June 21, 2011

    Report

    Report Number
    1317056-2011-00064
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K030083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. THE (B)(6) 2011 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PORTS AND THE FAILURE MODE OF "CATHETER BROKE/MIGRATED." NO ADVERSE TRENDS WERE IDENTIFIED. THE ROOT CAUSE FOR THE HOSPITAL'S COMPLAINT IS INCONCLUSIVE. WITHOUT RECEIVING A SAMPLE FOR EVAL, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE REPORTED LOCATION OF THE SEVERED CATHETER AND THE "CLEAN CUT/TEAR", THE MOST PROBABLE ROOT CAUSE FOR THIS ISSUE IS DUE TO "PINCH OFF SYNDROME". HOWEVER, WITHOUT RECEIVING A SAMPLE FOR EVAL, WE CANNOT DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS COMPLAINT. INCOMING INSPECTION PROCESS CONTROLS FOR THE CATHETER INCLUDE DIMENSIONAL INSPECTIONS, STATIC BURST TESTING AND TENSILE TESTING. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, VALVED PORT/CATHETER HAD BEEN IMPLANTED IN PT ON (B)(6) 2008. WHEN PT CAME IN TO HAVE PORT REMOVED ON (B)(6) 2011, A PRE-SCAN SHOWED A SPLIT AT THE VESSEL ENTRY SITE. THE PROXIMAL 1/3 OF THE CATHETER WAS STILL CONNECTED TO THE HUB OF THE PORT, BUT THE DISTAL 2/3 WAS LOCATED IN THE RIGHT INTERNAL JUGULAR. THE SPLIT LOOKED LIKE A CLEAN CUT/TEAR. THE PHYSICIAN SUCCESSFULLY REMOVED THE PORT AND THE CATHETER SECTIONS. THE PT HAD COMPLAINED OF HEADACHES AND RECALLED A PARTICULAR MOMENT, ONE WEEK PRIOR TO THE DEVICE BEING REMOVED, WHEN SHE HEARD A "POP," IN HER EAR ON THE RIGHT SIDE OF HER NECK. NO PT COMPLICATIONS RESULTED FROM THE DEVICE REMOVAL. THE USED DEVICE WAS RETAINED BY THE HOSP AND IS NOT BEING RETURNED TO NAVILYST MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / VAXCEL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1288648

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention