BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNSURE SOURCE OF "FUZZY FIBERS" CARDIAC CATH PACK

    MDR report key: 22882549 · Received August 25, 2025

    Report

    Report Number
    MW5175145
    Event Type
    Death
    Date Received
    August 25, 2025
    Date of Event
    November 7, 2024
    Report Date
    August 19, 2025
    Manufacturer
    UNKNOWN
    Product Code
    OES
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TRANSFERRED FROM OSH (B)(6) AFTER PRESENTING WITH STROKE SYMPTOMS. PMH CABG, BIOPROSTHETIC AVR, CEREBRAL ANEURYSM AND (AFIB) ATRIAL FIBRILLATION (NO AC DUE TO FALL RISK). CT NEGATIVE FOR LARGE VESSEL OCCLUSION. RECEIVED TENECTEPLASE 0.25 MG/KG PRIOR TO TRANSFER DEACONESS HENDERSON. WITHIN 8 HOURS OF ADMINISTRATION, SA BECAME BRADYCARDIC WITH WORSENING (NIH SCORE) NATIONAL INSTITUTES OF HEALTH STROKE SCALE SCORE. REPEAT CT SHOWED NEW (ICH) INTRACEREBRAL HEMORRHAGE. (TXA) TRANEXAMIC ACID BOLUS WAS GIVEN AND SA WAS TRANSFERRED TO (B)(6) ON (B)(6). FIBRINOGEN LEVEL 241 UPON ARRIVAL AND NO FURTHER TXA WAS GIVEN. NICARDIPINE DRIP WAS ORDERED FOR (BP) BLOOD PRESSURE CONTROL. CLOPIDOGREL STARTED (B)(6). SA MAINTAINED ABILITY TO SPEAK, FOLLOW COMMANDS UNTIL BEGAN TO DEVELOP RESPIRATORY FAILURE ON (B)(6). SA REQUIRED INTUBATION ON (B)(6). DESPITE ATTEMPTS MADE TO OPTIMIZE CLINICAL CONDITION, SA CONTINUED TO FAIL (SBT) SPONTANEOUS BREATHING TRIAL. SA INDICATED SHE DID NOT WANT A TRACH SO TERMINAL EXTUBATING WAS DONE (B)(6) AND SA EXPIRED SHORTLY AFTER. PATIENT CODES: 1891, 1751, 2484. REFERENCE REPORT #MW5175143, #MW5175144, #MW5175146.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291700 UNSURE SOURCE OF "FUZZY FIBERS" CARDIAC CATH PACK CARDIAC CATHETERIZATION KIT OES UNKNOWN (10)25EBC932

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Death CLOPIDOGREL.| NICARDIPINE.| TENECTEPLASE.