BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2 FR PER-Q-CATH PLUS PICC WITH STYLET, BASIC

    MDR report key: 3020963 · Received March 20, 2013

    Report

    Report Number
    3006260740-2013-00129
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    November 28, 2012
    Report Date
    January 2, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K954104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF A CATHETER LEAK IS CONFIRMED. A SINGLE PINHOLE LEAK WAS IDENTIFIED DURING HYDRAULIC PRESSURIZATION. IT SHOULD BE NOTED THAT THE LEAK IS ONLY OBSERVED DURING HYDRAULIC PRESSURIZATION. THE LEAK APPEARS AS SMALL BEAD OF WATER. THE LEAK SITE IS LOCATED 1.3 INCHES PROXIMAL TO THE DISTAL TIP OF THE CATHETER. NO MECHANICAL DAMAGE TO THE CATHETER WAS OBSERVED. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE (IFU) THE CATHETER SHOULD BE FLUSHED TO ACTIVATE THE HYDROPHILIC COATING ON THE STYLET WIRE. WHEN IT IS NOT RPE-FLUSHED, THE WIRE CAN CAUSE A SERIES OF HOLES SIMILAR TO THAT WHICH IS FOUND ON THE IMPLICATED CATHETER. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. THE PER-Q-CATH CATHETER COMES WITH A STYLET WIRE PRE-INSERTED INTO THE CATHETER LUMEN. THE STYLET HAS A HYDROPHILIC COATING ON THE OUTER COILS OF THE WIRE. THIS COATING EASES WIRE RETRACTION WHEN IRRIGATED MAKES THE SURFACE OF THE WIRE VERY SLIPPERY. ACTIVATION OF THIS FEATURE REQUIRES THE USER TO FLUSH THE CATHETER LUMEN PRIOR TO STYLET RETRACTION. IF THE USER DOES NOT IRRIGATE THE LUMEN PRIOR TO ATTEMPTING STYLET REMOVAL, THE INNER LUMEN CAN BE DAMAGED WHEN RESISTANCE MET IF THE USER CONTINUES TO APPLY TRACTION. ALSO, IF THE CATHETER IS NOT REPOSITIONED WHEN RESISTANCE IS ENCOUNTERED, OR IF THE CATHETER IS HELD BY A CLAMPING INSTRUMENT DURING STYLET RETRACTION, THE STYLET WIRE CAN DAMAGE THE INNER LUMEN OF THE CATHETER. THE OUTER COILS OF THE WIRE ACT AS AN ABRASIVE SAW AS IT IS DRAWN THROUGH THE LUMEN, LEAVING A TRENCH INSIDE THE LUMEN THAT MAY BREACH THE WALL. THE IFU GIVES FULL WARNINGS CONCERNING THIS ISSUE. TAGS AT THE PROXIMAL END OF THE STYLET WIRE AND THE IFU INSTRUCT THE USER TO PRE-FLUSH THE CATHETER WITH SALINE IN ORDER TO WET THE HYDROPHILIC STYLET. THE IFU CAUTIONS TO NEVER USE FORCE TO REMOVE THE STYLET AND GIVES SUGGESTION FOR HOW TO PROCEED WHEN RESISTANCE IS MET.

    Description of Event or Problem · 1

    IT IS REPORTED THAT AFTER THE PROCEDURE OF PASSAGE, IT WAS OBSERVED THE PRESENCE OF TWO HOLES NEAR THE BUTTERFLY. THE CATHETER WAS REMOVED AND ANOTHER CATHETER WAS PLACED WHICH ALSO PRESENTED A HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115265 2 FR PER-Q-CATH PLUS PICC WITH STYLET, BASIC LJS C. R. BARD INC. (BASD) REWA1394

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention