BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1011901 · Received March 11, 2008

    Report

    Report Number
    2024168-2008-00175
    Event Type
    Injury
    Date Received
    March 11, 2008
    Date of Event
    February 11, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION REPORTING RATIONALE: BALLOON CATHETER USED TO REMOVE SEPARATED GUIDE WIRE DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RCA. THE CASE WAS EXTREMELY CHALLENGING DUE TO THE HEAVY TORTUOSITY IN THE ILIAC AND THE AORTA. THE BMW UNIVERSAL GUIDE WIRE WAS ADVANCED, BUT WAS UNABLE TO CROSS THE LESION. THE GUIDE WAS REMOVED AND ONCE OUTSIDE THE PT, THE TIP WAS OBSERVED TO HAVE SEPARATED. THE SEPARATED TIP WAS LOCATED STILL INSIDE THE GUIDING CATHETER AND WAS SUCCESSFULLY REMOVED BY INFLATING A BALLOON INSIDE THE GUIDING CATHETER AND REMOVING EVERYTHING AS A SINGLE UNIT. THE SHEATH WAS EXCHANGED FOR A 55 CM SHEATH AND THE CASE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. THERE WERE NO PT EFFECTS. NO ADDITIONAL EVENT OR PT INFORMATION 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention SHEATH: 55 CM