BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 FR S/L POWERPICC WITH SAFETY MI IN UPFT

    MDR report key: 2110579 · Received May 26, 2011

    Report

    Report Number
    3006260740-2011-00156
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 10, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K033389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS CONFIRMED AND WILL BE RECORDED AS USER RELATED. AS EVIDENCED BY THE SAMPLE RETURNED IT APPEARS THE GUIDEWIRE HAS BEEN DAMAGED THROUGH USE. THE GUIDEWIRE IS SEVERELY ELONGATED AND THE CENTER CORE WIRE HAS SEPARATED FROM ITS WELD TIP. THE USER SHOULD NOT PULL THE GUIDEWIRE BACK OVER NEEDLE BEVEL AS THIS MAY SEVER THE END OF THE GUIDEWIRE. THE PRODUCT IFU CAUTIONS THE USER TO, "IF THE GUIDEWIRE MUST BE WITHDRAWN WHILE THE NEEDLE IS INSERTED, REMOVE BOTH THE NEEDLE AND WIRE AS A UNIT TO PREVENT THE NEEDLE FROM DAMAGING OR SHEARING THE GUIDEWIRE." THE INTRODUCER NEEDLE MUST BE REMOVED FIRST. ALSO, IF UNUSUAL RESISTANCE IS MET DURING MANIPULATION OF THE GUIDEWIRE, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. THE DAMAGED INCURRED TO THE GUIDEWIRE EXHIBITS A SEVERED SECTION OF THE WIRE, SEVERE ELONGATION OF THE OUTER COILS AND SEPARATION OF THE CENTER WIRE FROM THE DISTAL WELD TIP. THIS APPEARS TO BE A USER TECHNIQUE ISSUE. THE PRODUCT IFU (INSTRUCTIONS FOR USE) GIVES WRITTEN AND ILLUSTRATED INSTRUCTIONS ON THE PROPER PLACEMENT TECHNIQUES AND REMOVAL OF THE GUIDEWIRE. A LHR OF REUK0972 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE NURSE FEELS THAT THE WIRE IS SHORTER THAN NORMAL AND THAT IT FEELS DIFFERENT THAN NORMAL. DURING PLACEMENT, THE FLOPPY TIP UNRAVELED THEN BROKE OFF AND WENT IN THE PT. THE BROKEN PART WAS PICKED AWAY FROM THE PT WITHOUT FURTHER COMPLICATIONS. THE REP FEELS THAT THE NURSE MAY HAVE PULLED THE WIRE BACK THROUGH THE INTRODUCER NEEDLE TO CAUSE THE UNRAVELING. ON (B)(4) 2011, PER MEDWATCH: UPON PICC LINE REMOVAL, THE GUIDEWIRE UNRAVELED. SIX CM LEFT IN PT, BUT RN WAS ABLE TO REMOVE ENTIRE 6 CM. THE TOTAL LENGTH OF A GUIDEWIRE IS 50CM. THE RN WAS ABLE TO MEASURE THE GUIDEWIRE AFTER REMOVAL FOR BOTH PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR S/L POWERPICC WITH SAFETY MI IN UPFT LJS C. R. BARD, INC. (BASD) REUK0972

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention