BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS GUIDE WIRE

    MDR report key: 1884676 · Received October 25, 2010

    Report

    Report Number
    2024168-2010-02255
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNK PROGRESS, INDICATED IS BEING FILED UNDER A SEPARATE MFR #. EVALUATION SUMMARY: INABILITY TO CROSS THE LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. HAVING THE APPROPRIATE EQUIPMENT SELECTED FOR USE, RELATED TO THE CASE CONDITIONS, CAN ALSO SIGNIFICANTLY AFFECT CROSSING AND IT IS EXPECTED THAT WIRES WITH DIFFERENT PERFORMANCE PROPERTIES WOULD PERFORM DIFFERENTLY IN CROSSING ATTEMPTS. IT WAS REPORTED THAT THE VESSEL WAS TOTALLY OCCLUDED WHICH LIKELY CONTRIBUTED TO THE REPORTED INABILITY CROSSING THE LESION AND RESISTANCE AS EXPLAINED ABOVE. ADDITIONALLY, MULTIPLE PARTS OF DIFFERENT SIZES COULD NOT CROSS THE LESION WHICH SUGGESTS THAT THE ANATOMY WAS CHALLENGING. IT IS UNKNOWN IF THE PATIENT EFFECT OF THROMBOSIS OCCURRED AS A RESULT OF RESISTANCE CAUSING A DELAY IN THE CASE, OR IF OTHER FACTORS SUCH AS OVERALL HEALTH, CONDITION OF THE PATIENT, OR CURRENT MEDICATIONS THE PATIENT WAS OR WAS NOT TAKING CONTRIBUTED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. OVERALL, THE REPORTED INABILITY CROSSING THE LESION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A TOTALLY OCCLUDED VESSEL, THE PHYSICIAN ATTEMPTED TO USE A PROGRESS 80 AND PROGRESS 120, BUT THE GUIDE WIRES WENT SUBINTIMAL AND WERE UNSUCCESSFUL. A CLOT AT THE DISTAL VESSEL WAS NOTED. NO TREATMENT WAS REPORTED. THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE PROGRESS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other GUIDE WIRE: UNK PROGRESS