BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL/VAXCEL

    MDR report key: 3945248 · Received May 6, 2014

    Report

    Report Number
    1317056-2014-00028
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 6, 2014
    Report Date
    April 7, 2014
    Manufacturer
    NAVILYST MED
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS GENERATED FOR ITEM NUMBER (B)(4) IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTED CUSTOMER IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHR WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(4) 2014 NAVILYST MED COMPLAINT REPORT WAS REVIEWED FOR THE PRODUCT FAMILY OF VAXCEL PASV PICC AND THE FAILURE MODE OF "HOLE DISTAL TO SUTURE WING." NO ADVERSE TRENDS WERE IDENTIFIED. A VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED A HOLE IN THE CATHETER SHAFT JUST DISTAL FROM THE SUTURE WING (~1.5MM FROM SUTURE WING). THE HOLE WAS A SLIT, STRAIGHT IN APPEARANCE AND ORIENTED PERPENDICULAR TO THE CATHETER SHAFT. THE CATHETER TUBING WAS KINKED IN THIS LOCATION WITH THE HOLE/SLIT BEING IN THE INSIDE CREASE OF THE KINK. THIS TUBING FAILURE IS CONSISTENT WITH A CATHETER THAT WAS REPEATEDLY KINKED AND THE HOLE DEVELOPED DUE TO FATIGUE IN THE KINKED AREA. WHEN THE CATHETER TUBING WAS CROSS-SECTIONED, NO ABNORMALITIES OR THIN SPOTS WERE FOUND IN THE AREA OF THE SPLIT AND THE ID AND OD OF THE CATHETER WERE WITHIN SPECIFICATION. BASED ON THE LOCATION AND VISUAL APPEARANCE OF THE HOLE IN THE CATHETER TUBING, THE MOST LIKELY ROOT CAUSE IS FATIGUE DUE TO REPEATING KINKING. EVIDENCE TO SUPPORT THIS IS WHEN THE CATHETER TUBING IS KINKED AT THE FRACTURE LOCATION, THE INSIDE CREASE OF THE KINK IS LINED UP WITH THE FRACTURE. A CONTRIBUTING FACTOR MAY ALSO INCLUDE NOT ALLOWING CLEANSING AGENTS (ISOPROPYL ALCOHOL OR ACETONE BASED) TO COMPLETELY DRY PRIOR TO COVERING DURING DRESSING CHANGES. ADDITIONAL FACTORS INVOLVED IN THE REPEATED CATHETER KINKING MAY BE THE LENGTH OF CATHETER TUBING LEFT EXTERNAL FROM THE INSERTION SITE (I.E. TOO SHORT, NOT ENOUGH SLACK), PLACEMENT OF THE STATLOCK (OR SIMILAR PICC SECUREMENT DEVICE) TOO CLOSE TO THE INSERTION SITE AND ORIENTATION OF THE PICC SUTURE WING/EXTENSION TUBES (I.E. EXTENSION TUBES POINTING TOWARD SHOULDER). MFG PROCESS CONTROLS IN PLACE FOR THE PICC DEVICE INCLUDES IN-PROCESS VISUAL INSPECTION FOR DAMAGE OR DEFECTS, AS WELL AS 100% AIR LEAK TESTS AND GUIDEWIRE INSERTION CHECKS FOR LUMEN PATENCY. INCOMING INSPECTION PROCESS CONTROLS FOR THE PICC TUBING INCLUDE VISUAL INSPECTION AS WELL AS A GUIDEWIRE INSERTION CHECK FOR LUMEN PATENCY. THE VAXCEL PASV PICC DIRECTIONS FOR USE (DFU) THAT IS SUPPLIED WITH THE REPORTED DEVICE PROVIDES GUIDELINES, PRECAUTIONS AND WARNINGS THAT SHOULD BE FOLLOWED BY THE END USER IN ORDER TO PROLONG THE USABLE LIFE OF THE CATHETER AND TO REDUCE THE RISK OF DAMAGING THE CATHETER. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DIST IN THE (B)(6), "PICC WAS PLACED ON (B)(6) 2013 USING SECURACATH. PICC WAS FOUND TO BE SPLIT ON (B)(6) 2014 AND WAS REMOVED." THE USED DEVICE HAS BEEN RETURNED TO NAVILYST MED FOR EVALUATION. NO COMPLICATIONS RESULTED FROM THIS EVENT AND THE CURRENT PT CONDITION IS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271002 NAVILYST MEDICAL/VAXCEL CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1