BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6 FR T/L POWERPICC SOLO NURSE BASIC WITH MI AND TLS

    MDR report key: 1930438 · Received November 18, 2010

    Report

    Report Number
    3006260740-2010-00343
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT THAT THE DISTAL TIP OF THE TLS STYLISTS DETACHED WAS CONFIRMED. THE PRODUCTS RETURNED FOR EVAL WERE TWO TLS STYLETS WITH A BREAK WITHIN THE DISTAL MAGNET REGION AND TWO SMALL SEGMENTS OF THE TLS STYLETS. THE PROXIMAL SEGMENTS INCLUDED THE YELLOW PULL-TAB, THE T-LOCK ASSEMBLY, THE CENTRAL CORE WIRE AND SOME OF THE MAGNETIC REGION. MULTIPLE KINKS WERE SEEN IN THE MAGNETIC REGIONS OF THE STYLETS. ONE OF THE SAMPLES CONTAINED A SMALL SECTION OF STRETCHED EMPTY POLYIMIDE TUBING. THE BREAK ON THIS SAMPLE WAS INTRAMAGNETIC, BREAKING THE DISTAL MAGNET. THE MAGNET WAS SLIGHTLY RECESSED WITHIN THE TUBING AND THE POLYIMIDE TUBING WAS BENT OVER THE MAGNET. THE BREAK ON THE OTHER SAMPLE WAS AN INTERMAGNETIC BREAK WITH THE DISTAL END OF THE MAGNET PROTRUDING SLIGHTLY OUT OF THE POLYIMIDE TUBING. THE SMALLER RETURNED SEGMENTS WERE FROM THE MAGNETIC REGION OF THE TLS STYLETS. ONE OF THE SMALL SEGMENTS WAS BROKEN ON BOTH ENDS. THE SEGMENT CONTAINED SEVEN COMPLETE MAGNETS AND ONE PARTIAL MAGNET. THIS SEGMENT WAS 0.72" LONG. THE MAGNETS WERE RECESSED WITHIN THE POLYIMIDE TUBING ON ONE SIDE AND PROTRUDING FROM THE TUBING ON THE OTHER SIDE. THE TUBING WAS BENT OVER THE RECESSED MAGNET. THE OTHER MAGNETIC REGION PIECE CONTAINED 6 MAGNETS AND THE DISTAL EPOXY TIP. THIS SEGMENT WAS 0.68" LONG. THE PROXIMAL MAGNET WAS SLIGHTLY RECESSED WITHIN THE TUBING AND THE BLUE SHRINK TUBING WAS BENT OVER THE END OF THE MAGNET. THE POLYIMIDE TUBING WAS BENT OUT OF ROUND. THE PRODUCT IFU WARNS, "ENSURE THAT THE STYLET TIP DOES NOT EXTEND BEYOND THE TRIMMED END OF THE CATHETER. EXTENSION OF THE STYLET TIP BEYOND THE CATHETER END, COMBINED WITH KINKING AND EXCESSIVE FORCES MAY RESULT IN VESSEL DAMAGE, STYLET DAMAGE, DIFFICULT REMOVAL, STYLET TIP SEPARATION, POTENTIAL EMBOLISM AND RISK OF PT INJURY." A CHR OF LOT # REUC0757 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR ADVANCED THE CATHETER AND IT WENT INTO THE SIDE VESSEL. CONTINUED TO ADVANCE THINKING SHE WAS IN BASILIC AND KINKED THE CATHETER. PULLED CATHETER BACK AND OUT. NURSE PULLED STYLET BACK AND FLUSHED, BUT NOTICED STYLET TIP VISIBLE AT END. PULLED THE STYLET WIRE FROM DISTAL END AND FOUND THE TLS STYLET HAD KINKED AND BROKEN INTO TWO PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 FR T/L POWERPICC SOLO NURSE BASIC WITH MI AND TLS LJS C. R. BARD INC. (BASD) REUC0757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention