BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JET7 REPERFUSION CATHETER

    MDR report key: 11405450 · Received March 3, 2021

    Report

    Report Number
    3005168196-2021-00392
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    July 12, 2020
    Report Date
    February 1, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    PMA / PMN Number
    K173761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE,VESSEL SPASM, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) AND RIGHT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7). DURING THE PROCEDURE, THE PHYSICIAN COMPLETED TWO PASSES USING THE JET7. AFTERWARDS, THE PHYSICIAN PERFORMED A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) THROUGH THE JET7 IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) RESULTING THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) 3; HOWEVER, THE PHYSICIAN NOTICED VASOSPASM IN THE RIGHT MCA. THE PHYSICIAN INFUSED 10MG OF INTRA-ARTERIAL VERAPAMIL THROUGH THE JET7 IN THE RIGHT ICA USING A SLOW HAND BOLUS TECHNIQUE OVER APPROXIMATELY 10 MINUTES. POST VERAPAMIL INFUSION, THE PHYSICIAN PERFORMED ANOTHER DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWING CORRECTION OF THE VASOSPASM. THE EVENT WAS CONSIDERED RESOLVED THE SAME DAY WITH THE INFUSION OF VERAPAMIL. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND JET7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300870 PENUMBRA SYSTEM JET7 REPERFUSION CATHETER HCG, KRD HCG PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention