BEUDAMED
    FDA Adverse Event Death Summary report: N

    HI-TORQUE WHISPER GUIDE WIRE

    MDR report key: 1725458 · Received June 11, 2010

    Report

    Report Number
    2024168-2010-01150
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 18, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFO. THE 3.0 X 19 MM GRAFTMASTER (PART 12744-19, LOT 501304), HAS BEEN FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PERFORATION AND HYPERTENSION, SUBSEQUENT DEATH. ONSET OF ADVERSE EVENT: POST PROCEDURE. IT WAS REPORTED THAT THE PT ARRIVED IN THE CATH LAB FROM INTENSIVE CARE UNIT (ICU) ON A VENTILATOR. DURING THE PROCEDURE TO TREAT THE CIRCUMFLEX A PERFORATION OCCURRED WITH THE USE OF A WHISPER GUIDE WIRE. THE GRAFTMASTER STENT WAS BEING USED IN AN ATTEMPT TO TREAT THE PERFORATION; HOWEVER, IT WOULD NOT CROSS. THE PT DEVELOPED CARDIAC TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED. THE PT BECAME HYPOTENSIVE AND WAS PUT ON AN INTRA AORTIC BALLOON PUMP (IABP). THE PT DIED AT 1:46 ON (B) (6) 2010. NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death LOT 501304)| STENT: 3.0 X 19 MM GRAFTMASTER (PART 12744-19,