BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 9619438 · Received January 22, 2020

    Report

    Report Number
    3005168196-2020-00078
    Event Type
    Injury
    Date Received
    January 22, 2020
    Date of Event
    May 31, 2019
    Report Date
    December 31, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, DISTAL EMBOLIZATION, NEUROLOGICAL DEFICITS INCLUDING STROKE, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K133317.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) SUPRACLINOID USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A VELOCITY MICROCATHETER, A NON-PENUMBRA DIAGNOSTIC CATHETER, GLIDEWIRE AND NON-PENUMBRA MICROGUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN POSITIONED THE NEURON MAX IN THE RIGHT COMMON CAROTID ARTERY OVER A NON-PENUMBRA DIAGNOSTIC CATHETER AND GLIDEWIRE. NEXT, A JETD WAS ADVANCED IN THE RIGHT INTERNAL CAROTID ARTERY OVER THE VELOCITY AND MICROGUIDEWIRE. THEN, THE JETD ALONG WITH THE STENT RETRIEVER WERE ADVANCED TO THE FACE OF THE CLOT AND ASPIRATION WAS STARTED. AFTER ONE PASS, COMPLETE REVASCULARIZATION WAS OBTAINED; HOWEVER, A SMALL PIECE OF CLOT BROKE OFF AND BECAME LODGED IN THE RIGHT PERICALLOSAL ARTERY. TWO ADDITIONAL PASSES WERE MADE WITH THE STENT RETRIEVER AND JETD BUT WERE UNSUCCESSFUL. THE DECISION WAS MADE TO END THE PROCEDURE AT THIS POINT. 24 HOURS POST-PROCEDURE, THE PATIENT¿S NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) INCREASED 4 POINTS FROM 15 AT BASELINE TO 19. IT WAS REPORTED THAT THE PATIENT EXPERIENCED TIREDNESS BUT DENIES ANY SPECIFIC COMPLAINTS. IT SHOULD BE NOTED THAT NO MEDICATION OR MEDICAL PROCEDURE WERE REQUIRED TO ADDRESS THE PROGRESSION OF INDEX STROKE. THIS EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2019. THE PROGRESSION OF INDEX STROKE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT RELATED TO PENUMBRA SYSTEM JETD REPERFUSION CATHETER, THE INDEX STROKE, AND THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79375 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR