BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

    MDR report key: 1020586 · Received March 28, 2008

    Report

    Report Number
    2024168-2008-00233
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    November 12, 2007
    Report Date
    February 27, 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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. CINE REVIEW SUGGESTS THAT THE UNIVERSAL BMW DEVICE MAY HAVE CAUSED THE PERFORATION DUE TO THE LOCATION OF THE PERFORATION IN RELATION TO THE GUIDE WIRE POSITION. VESSEL TRAUMA, TO INCLUDE A PERFORATION, IS A POTENTIAL HAZARD DESCRIBED IN THE IFU AND IS NOT GENERALLY ASSOCIATED WITH A GUIDE WIRE QUALITY ISSUE. A PERFORATION WOULD TYPICALLY BE RELATED TO CIRCUMSTANCES IN THE PROCEDURE SUCH AS ANATOMY, MORPHOLOGY AND PHYSICIAN TECHNIQUE. MOVING THE GUIDE WIRE AGAINST RESISTANCE WOULD BE REQUIRED TO PERFORATE AND THE IFU WARNS NOT TO MOVE THE GUIDE WIRE AGAINST RESISTANCE ALTHOUGH CASE CIRCUMSTANCES CAN CAUSE UNEXPECTED GUIDE WIRE MOVEMENT AGAINST RESISTANCE. THE MINI VISION CROSSING DIFFICULTY AND REPORTED STENT DAMAGE MAY HAVE INDIRECTLY HAD AN AFFECT ON GUIDE WIRE POSITIONING AND MOVEMENT ALTHOUGH THE EXACT FACTORS THAT CAUSED THE PERFORATION COULD NOT BE DETERMINED; THEREFORE, NO INDICATION OF A QUALITY ISSUE ASSOCIATED WITH THE PERFORATION, NO MFG RELATED ROOT CAUSE CAN BE DETERMINED. THE RX VISION INDICATED IN THE EVENT DESCRIPTION AND IN CONCOMITANT MEDICAL PRODUCTS IS BEING REPORTED UNDER MFR # 2024168-2008-00232.

    Description of Event or Problem · 1

    REPORTING RATIONALE: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING STATUS: PERFORATION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED THAT THE PT ARRIVED WITH CHEST PAIN. THE PROCEDURE WAS TREAT A POSSIBLY RE-STENOSED VISION STENT, IN THE M4 OF THE CIRCUMFLEX. AN ATTEMPT WAS MADE TO PLACE A 2.25 X 15 MM MINIVISION STENT, USING A BMW UNIVERSAL GUIDE WIRE, BUT THE MINIVISION FAILED TO CROSS THE PREVIOUSLY IMPLANTED STENT. WHEN THE STENT DELIVERY SYSTEM AND THE GUIDE WIRE WERE REMOVED FROM THE PT, A PERFORATION WAS OBSERVED. A SURGEON WAS CALLED IN TO PLACE COILS TO SEAL THE PERFORATION. A CD OF THE PROCEDURE WAS RETURNED FOR REVIEW. BASED ON THE CD REVIEW, IT APPEARS THAT THE GUIDE WIRE MAY HAVE CAUSED THE PERFORATION. NO ADD'L 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 74DQX DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention GUIDING CATHETER: 6F CORDISXB 3.0| STENT: RX VISION DOC EXTENSION 145 CM| 2.0 X 12 MM VOYAGER| JL 4.0| SHEATH: TERUMO 6F| OTHER: 6F MDT EXPORT ASPIRATION XT| DILATION CATHETER: 3.0 X 12 MM VOYAGER| RENEGADE MICRO CATHETER