BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4FR S/L POWERPICC SOLO FULL TRAY

    MDR report key: 2780628 · Received October 5, 2012

    Report

    Report Number
    3006260740-2012-00352
    Event Type
    Injury
    Date Received
    October 5, 2012
    Report Date
    September 10, 2012
    Manufacturer
    C. R. BARD INC.
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE 3CG STYLET WAS CONFIRMED BUT THE CAUSE IS UNK. THE STYLET WAS RETURNED IN TWO SEGMENTS WITH A COMPLETE BREAK IN THE MAGNETIC REGION. THE PROXIMAL SEGMENT CONTAINED TWO KINKS IN THE CORE WIRE, 10.5¿ AND 16.0¿ DISTAL OF THE YELLOW TAB. A SMALL RIDGE WAS FELT ON THE CORE WIRE 22.0¿ FROM THE YELLOW PULL TAB. MICROSCOPIC EXAMINATION REVEALED A CLEAR MATERIAL BUNCHED UP ALONG THE WIRE. THE MATERIAL APPEARED TO BE LAYERS OF THE HYDROPHILIC COATING. THE DETACHED DISTAL SEGMENT CONTAINED APPROXIMATELY FIFTEEN AND A HALF MAGNETS. THIS SEGMENT CONTAINED A KINK 0.7¿ FROM THE DISTAL END. INTRAMAGNETIC BREAKS WERE SEEN AT THE BREAK SITE AND WHERE THE STYLET WAS KINKED. THE BREAK EDGES ON THE POLYIMIDE TUBING WERE JAGGED AND IRREGULAR. THE FRACTURE SURFACE WAS GRANULAR. THE CORE WIRE HAD BROKEN DISTAL OF THE POLYMIDE TUBING, SO 1.6¿ OF THE CORE WIRE PROTRUDED PAST THE BREAK IN THE POLYMIDE TUBING, SO 1.6¿ OF THE CORE WIRE PROTRUDED PAST THE BREAK IN THE POLYIMIDE TUBING. THE LENGTH OF THE CORE WIRE INDICATES THAT THE CORE WIRE BROKE EITHER AT OR VERY NEAR THE DISTAL END OF THE STYLET. THE EXACT MECHANISM WHICH CAUSED THE BREAK IN THE STYLET IS UNK AT THIS TIME. THIS TYPE OF FAILURE CAN OCCUR DUE TO A DIFFICULT PLACEMENT OR IF THE STYLET IS ADVANCED TOO FAR IN THE CATHETER. THE IFU STATES ¿ENSURE THAT THE STYLET TIP DOES NOT EXTEND BEYOND THE TRIMMED END OF THE CATHETER. EXTENSION OF THE STYLET TIP 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 LOT HISTORY REVIEW (LHR) OF (B)(4) SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    NO DIFFICULTY INSERTING OR REMOVING WIRE. WHEN WIRE WAS REMOVED NOTICED WIRE HAD BROKEN OFF. FOUR CENTIMETERS INTO ATRIUM. ALL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4FR S/L POWERPICC SOLO FULL TRAY LJS C. R. BARD INC. REWE1937

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention