BEUDAMED
    FDA Adverse Event Death Summary report: N

    JOSTENT GRAFTMASTER

    MDR report key: 1712095 · Received June 3, 2010

    Report

    Report Number
    2024168-2010-01093
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    May 3, 2010
    Report Date
    May 11, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    HDE00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE UNK WHISPER GUIDE WIRE IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    DEVICE ISSUE: FAILURE TO CROSS. TIME OF DEVICE ISSUE: DURING THE PROCEDURE. ADVERSE EVENT: DEATH. ONSET OF ADVERSE EVENT: POST PROCEDURE. IT WAS REPORTED THAT THE PATIENT ARRIVED IN THE CATH LAB FROM THE INTENSIVE CARE UNIT ON A VENTILATOR. DURING THE PROCEDURE TO TREAT THE CIRCUMFLEX ARTERY, 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 PATIENT DEVELOPED CARDIAC TAMPONADE AND PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT BECAME HYPOTENSIVE AND WAS PUT ON AN INTRA AORTIC BALLOON PUMP. THE PATIENT DIED AT 1:46 ON (B) (6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOSTENT GRAFTMASTER MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 501304

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death GUIDE WIRE: UNK WHISPER