BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3941457 · Received July 17, 2014

    Report

    Report Number
    2024168-2014-04592
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: WHISPER MS; STENT: 2.75X23MM XIENCE PRIME. THERE WAS NO REPORTED DEVICE MALFUNCTION, AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED, BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATATED USING AN UNSPECIFIED BALLOON DILATATION CATHETER (BDC). AFTER PLACEMENT OF A WHISPER GUIDE WIRE IN THE RCA, THE 2.75X23MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION REPORTEDLY DUE TO INTERACTIONS WITH THE PATIENT'S ANATOMY. A SECOND WHISPER GUIDE WIRE WAS PLACED IN A SMALL SIDE BRANCH IN AN ATTEMPT TO USE THE ANCHOR TECHNIQUE. HOWEVER, THE SMALL SIDE BRANCH RUPTURED (PERFORATION). A 2.8X19MM GRAFTMASTER WAS UNABLE TO CROSS THE SMALL SIDE BRANCH TO TREAT THE PERFORATION; THEREFORE, THE PERFORATION WAS SEALED WITH ANGIOPLASTY USING AN UNSPECIFIED BDC. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 2.5X18MM NON-ABBOTT STENT WAS DEPLOYED TO TREAT THE TARGET LESION IN THE RCA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418702 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention CONCOMITANT MEDICAL DEVICES