BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2223848 · Received August 18, 2011

    Report

    Report Number
    3005168196-2011-00322
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    January 11, 2010
    Report Date
    July 26, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFORMATION IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A PENUMBRA POST-MARKET RETROSPECTIVE STUDY (RETROSTART). THE INFORMATION AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE HOSPITAL FOR SHORTNESS OF BREATH AT THE TIME OF STROKE ONSET THE EVENING OF (B)(6) 2010. THE PATIENT HAD SYMPTOMS OF ACUTE STROKE INCLUDING LEFT SIDED WEAKNESS AND FACIAL DROOP, WITH DYSARTHRIA. AT STROKE ONSET, THE PATIENT PRESENTED WITH AN (B)(6) OF 25 AND EVIDENCE OF AN OCCLUSION IN THE RIGHT M1. THE PATIENT RECEIVED NO TREATMENT PRIOR TO USE WITH THE PENUMBRA STROKE SYSTEM AND THE PROCEDURE BEGAN EARLY MORNING OF (B)(6) 2010, IN WHICH THE PENUMBRA SYSTEM REPERFUSION CATHETER 054 WAS USED COAXIALLY WITH THE PENUMBRA SYSTEM REPERFUSION CATHETER 032. FOLLOWING ASPIRATION, 9MG OF RETAVASE IA LYTIC WAS GIVEN INTO THE M2 BRANCH OF THE SUPERIOR DIVISION. ADDITIONALLY, A PENUMBRA SYSTEM REPERFUSION CATHETER 041 WAS USED FOR ASPIRATION IN THE INFERIOR TRUNK AND SUPERIOR DIVISION OF THE MCA. A REVIEW OF THE CLINICAL REPORT REVEALED THE PATIENT EXPERIENCED A SPASM DURING THE PROCEDURE THAT WAS TREATED WITH 5MG OF VERAPAMIL. THE RELATIONSHIP WAS DEFINED AS "POSSIBLE" TO THE STUDY DEVICE AND "PROBABLE" TO THE ANGIOGRAPHIC PROCEDURE. THE EVENT WAS RESOLVED THAT SAME DAY, ALTHOUGH THE VERAPAMIL WAS NOTED TO HAVE RESULTED IN MINIMUM IMPROVEMENT. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00323 THROUGH 3005168196-2011-00327.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention