BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER LS GUIDE WIRE

    MDR report key: 2936294 · Received January 30, 2013

    Report

    Report Number
    2024168-2013-00519
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 7, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF A PERFORATION, AS LISTED IN THE HI-TORQUE GUIDE WIRE INSTRUCTIONS FOR USE (IFU) IS A KNOWN ADVERSE EVENT ASSOCIATED WITH THE USE OF GUIDE WIRES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THIS EVENT WAS CAPTURED BASED ON REVIEW OF AN ARTICLE: A NOVEL GUIDE WIRE APPROACH FOR HANDLING ACUTE-ANGLE BIFURCATIONS: REVERSED GUIDE WIRE TECHNIQUE WITH ADJUNCTIVE USE OF A DOUBLE-LUMEN MICROCATHTER. REFERENCE CASE 3 ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A GUIDING CATHETER WAS INSERTED, BUT THE IVUS CATHETER COULD NOT CROSS THE LESION. ROTATIONAL ATHERECTOMY WAS PERFORMED. USING A REVERSE GUIDE WIRE TECHNIQUE, A WHISPER GUIDE WIRE AND A NON-ABBOTT CATHETER WERE USED FOR PRE-DILATATION AND AN UNKNOWN BARE METAL STENT WAS IMPLANTED. A HIGH PRESSURE POST DILATATION WAS PERFORMED WITH GOOD RESULTS. HOWEVER, THE CORONARY ANGIOGRAM DISPLAYED A CONTRAST MATERIAL STAIN IN THE EPICARDIUM, WHICH SUGGESTED ACCIDENTAL CORONARY PERFORATION BY THE WHISPER LS WIRE. THE PERFORATION WAS SUCCESSFULLY TREATED WITH MEDICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40885 HI-TORQUE WHISPER LS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention