BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR -40 CC

    MDR report key: 1895511 · Received November 5, 2010

    Report

    Report Number
    1219856-2010-00809
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 27, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K970689
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    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 TO BIOMED FROM THE NURSE MGR THAT ON MONDAY, (B)(6), THE PT WAS SCHEDULED FOR OPEN HEART SURGERY. THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE LEFT FEMORAL ARTERY. DURING SURGERY, THE INTRA-AORTIC BALLOON PUMP (IABP) ALARMED HELIUM LEAK. THE PT RECEIVED IABP THERAPY UNTIL WEDNESDAY, (B)(6). AS THE MD WAS REMOVING THE IAB FROM THE PT, HE MET RESISTANCE. IT WAS NOTED THAT A PIECE OF THE MEMBRANE FROM THE IAB REMAINED IN THE PT. THE PT WAS TAKEN TO SURGERY AND THE PIECE OF MEMBRANE WAS REMOVED. THERE WAS NO REPORTED PT DEATH. MEDICAL/SURGICAL WAS REQUIRED. THE PT UNDERWENT A THROMBECTOMY, PATCH ANGIOPLASTY OF THE LEFT COMMON FEMORAL ARTERY/SUPERFICIAL FEMORAL ARTERY AND RETRIEVAL OF THE BALLOON FRAGMENT. HE HAS DONE WELL AND HIS DISTAL EXTREMITY IS FINE. THE PT OUTCOME IS LISTED AS FINE AND THE PT IS IN THE CARDIOTHORACIC INTENSIVE CARE UNIT (CTICU). ADD'L INFO RECEIVED FROM BIOMED ON 11/1/2010 STATED THAT THE IAB WAS INSERTED USING A SHEATH. "THE IAB WAS INSERTED ON (B)(6) IN THE EVENING. IT WAS PLACED ON 1:4 ON (B)(6) AT 7 AM AND REMOVED ON (B)(6) AT 8 AM."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INTRA-AORTIC BALLOON PUMP