BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSEAL SURGICAL SEALANT

    MDR report key: 3428291 · Received October 24, 2013

    Report

    Report Number
    2032282-2013-00141
    Event Type
    Injury
    Date Received
    October 24, 2013
    Date of Event
    August 16, 2012
    Report Date
    October 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE LACK OF INFORMATION THIS CASE IS CURRENTLY NOT ASSESSABLE, THEREFORE IT IS BEING CONSERVATIVELY REPORTED. BAXTER IS CURRENTLY IN THE PROCESS OF FOLLOWING-UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: THE ADDITIONAL CLINICAL INFORMATION RECEIVED IS INDICATIVE FOR A THROMBOEMBOLIC OCCLUSION OF THE LVAD, INDEPENDENT OF THE USE OF COSEAL. THE THROMBOTIC EVENT HAS BEEN CAUSED BY A PATHOLOGIC INCREASE OF THE PLATELETS CONCENTRATION. THE SERIOUS ADVERSE EVENT IS CAUSALLY NOT ASSOCIATED WITH THE USE OF COSEAL. NO TREND IDENTIFIED. BASED ON THE REPORTED INFORMATION AND MEDICAL ASSESSMENT, NO FURTHER INVESTIGATION IS NECESSARY. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    (B)(6). (B)(4) #2: AS REPORTED MEDICAL TERM: CONTROL CABLE BREAK. EVENT DESCRIPTION: PAIN IN LOWER AND UPPER ARMS, HIGH LAB-PARAMETER LDH 850, BILIRUBIN 2.0. AT IMPLANT: (B)(6) 2011; PCK #: (B)(4); QUANTITY USED: 8ML. EVENT ONSET DATE: (B)(6) 2012. EVENT STOP DATE: (B)(6) 2012. OUTCOME AT TIME OF REPORT: RESOLVED. TREATMENT(S) USED TO TREAT EVENT(S): CHANGE OF PUMP DUE TO PUMP-THROMBOSIS.

    Description of Event or Problem · 1

    DATE OF SURGERY: (B)(6) 2012, AND INDICATION FOR SURGERY: PUMP THROMBOSIS, HÄMOLYSIS WHAT OCCURRED (THE MEDICAL TERM AS REPORTED: CONTROL CABLE BREAK IS NOT INDICATING A HARM, BUT A DEFECT)? HIGH ELEVATED LDH, FHB INDICATED THROMBUS IN PUMP. PLEASE DESCRIBE THE CHRONOLOGIC CHAIN OF EVENTS. HEMOLYTIC URINE 14 DAYS BEFORE AND AGAIN 2 DAYS BEFORE SURGERY, TECHNICAL ENERGY CONSUMPTION ELEVATED. WHAT CAUSED THE THROMBOSIS OF THE LVAD (FINDINGS AT REVISION SURGERY)? THROMBOPHILIE. HAS COSEAL PRODUCT PROTRUDED OR NARROWED THE INFLOW OR OUTFLOW GRAFTS OF THE PUMP? NO, HAS NOTHING TO DO WITH COSEAL. PLEASE PROVIDE DETAILS ON PATIENT OUTCOME AFTER REVISION SURGERY. PATIENT WAS DISCHARGED AFTER 5 DAYS, ALIVE, AT HOME, AND LISTED FOR HTX LOT NUMBER? NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546977 COSEAL SURGICAL SEALANT SEALANT,POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other