BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 3250442 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04705
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    March 13, 2012
    Report Date
    July 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISSECTION OCCURRED DURING USE OF A NON-ABBOTT STENT AND A NON-ABBOTT GUIDE WIRE. THE BMW GUIDE WIRE WAS USED TO REMOVE THE NON-ABBOTT DEVICES FROM THE ARTERY; HOWEVER, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) AND THE PATIENT WAS TAKEN FOR BY-PASS SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351043 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 1111072

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S