BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB : 8 FR - 40 CC

    MDR report key: 2542993 · Received April 16, 2012

    Report

    Report Number
    1219856-2012-00139
    Event Type
    Death
    Date Received
    April 16, 2012
    Date of Event
    March 9, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE MD ENCOUNTERED THE FOLLOWING: "THE SHEATH WAS KINKED AND THE BALLOON WAS NOT TRACKING OVER THE WIRE." AS A RESULT, THE MD REQUESTED A NEW INTRA-AORTIC BALLOON (IAB) FOR INSERTION. THE SECOND IAB WAS INSERTED SUCCESSFULLY. THERE WAS A REPORTED 5 TO 10 MIN DELAY IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY, HOWEVER THE DELAY DID NOT CAUSE HARM TO THE PT. THERE WERE NO REPORTED PT COMPLICATIONS; NO MEDICAL / SURGICAL INTERVENTION WAS REQUIRED. THE PT DID EXPIRE AND IT IS UNK IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PTS DEATH. ADD'L INFO REC'D ON (B)(4) 2012, STATED THAT THE SERVICE COORDINATOR SPOKE DIRECTLY TO THE DOCTOR TODAY. HE STATED THAT THE PT WAS A MI (MYOCARDIAL INFARCTION) PT; SO COMPLICATIONS WERE THERE, BUT THE DELAY OF 4 TO 8 MINS ALSO CONTRIBUTED TO THE PT'S DEATH UP TO SOME EXTEND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTERNATIONAL INC KF1101706

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death INTRA-AORTIC BALLOON PUMP