BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOSEAL

    MDR report key: 4891960 · Received July 6, 2015

    Report

    Report Number
    1416980-2015-27709
    Event Type
    Injury
    Date Received
    July 6, 2015
    Report Date
    June 11, 2015
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    LMF
    PMA / PMN Number
    P990009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AT THE TIME OF THE EVENT, THE PATIENT WAS UNDERGOING AN ENDOSCOPIC TRANSPHENOIDAL SURGERY. THERE WAS A TEAR IN THE INTERNAL CAROTID ARTERY AND FLOSEAL WAS APPLIED TO THE BLEEDING POINT. ONE OF THE INITIAL HYPOTHESIS WAS THAT THE FLOSEAL ENTERED THE CAROTID ARTERY AND CAUSED AN EMBOLIC STROKE. HOWEVER, IT WAS LATER RECOGNIZED THAT THE INFARCT PATTERN WAS OF A WATERSHED TYPE AND NOT AN EMBOLIC ONE. THIS WATERSHED INFARCT WAS LIKELY DUE TO PROLONGED BLOOD LOSS DURING THE SURGERY FROM THE TEAR IN THE CAROTID ARTERY AS IT TOOK SOME TIME TO EVENTUALLY CONTROL IT WITH A PIECE OF MUSCLE. THE PATIENT HAD CUSHING'S DISEASE BUT NO OTHER VASCULAR RISK FACTORS. THE WATERSHED INFARCT IS SUB CORTICAL IN DISTRIBUTION. BASED ON THIS NEW INFORMATION THERE IS NO LONGER ANY ALLEGATION AGAINST FLOSEAL. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DUE TO THE ADDITIONAL INFORMATION RECEIVED THE FLOSEAL IS NO LONGER CONSIDERED SUSPECT PRODUCT IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A STROKE SUBSEQUENT TO UNDERGOING A SURGERY IN WHICH FLOSEAL WAS USED TO STOP ARTERIAL BLEEDING. IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, FLOSEAL WAS USED BY A SURGEON TO STOP ARTERIAL BLEEDING AND THE FLOSEAL REPORTEDLY ENTERED THE ARTERY. SUBSEQUENTLY THE PATIENT EXPERIENCED A STROKE. MEDICAL INTERVENTION FOR THE EVENT WAS NOT REPORTED. THE PATIENT¿S OUTCOME WAS NOT REPORTED. THE SURGEON REPORTED THAT AFTER REVIEWING THE PATIENT, THE STROKE WAS CAUSED BY A WATERSHED INFARCT CAUSED BY HYPOTENSION AND WAS FURTHER DESCRIBED AS NOT CAUSED BY THE USE OF FLOSEAL. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435788 FLOSEAL AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMF BAXTER HEALTHCARE - HAYWARD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other