BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1438461 · Received April 10, 2009

    Report

    Report Number
    2024168-2009-00606
    Event Type
    Malfunction
    Date Received
    April 10, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 17, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. THE TWO OTHER BMW GUIDE WIRES WITH LOT# 8102491 ARE BEING REPORTED UNDER THIS SAME MANUFACTURER REPORT NUMBER. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE THREE GUIDE WIRES WERE RETURNED WITH NO BLOOD VISIBLE AND WITH CONTRAST VISIBLE ON THE TIP COILS. THE GUIDE WIRES' CORES WERE SEPARATED AT THE PROXIMAL END OF THE HYPOTUBES; HOWEVER, A SMALL PIECE OF THE CORES WERE STILL ATTACHED TO THE PROXIMAL ENDS OF THE HYPOTUBES. THE GUIDE WIRE WITH LOT # 8110395 HAD THE TIP COILS PUSHED DISTAL FROM THE CENTER SOLDER FOR A LENGTH OF 1 MM ON ONE OF THE GUIDE WIRES. THERE WAS NO DAMAGE NOTED TO THE GUIDE WIRES. THE TIPS OF THE GUIDE WIRES WERE TUGGED ON TO CONFIRM THAT THE SHAPING RIBBONS AND THE CORES WERE INTACT. THE GUIDE WIRES WERE SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. PRODUCT PERFORMANCE ENGINEERING HAS NOT COMPLETED THEIR INVESTIGATION AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: GUIDE WIRE TIP SEPARATION HAS CAUSED OR CONTRIBUTED TO PT INJURY PREVIOUSLY. DEVICE ISSUE: GUIDE WIRE TIP SEPARATION. IT WAS REPORTED THAT DURING SHAPING OF THE THREE GUIDE WIRES, THE TIPS COMPLETELY SEPARATED. THERE WAS NO PT INVOLVEMENT WITH ANY OF THE THREE GUIDE WIRES. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 8110395

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: (X2) BMW UNIVERSAL GUIDE WIRES