BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 2051491 · Received April 7, 2011

    Report

    Report Number
    3005168196-2011-00142
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VESSEL DISSECTION 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 INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A PENUMBRA (B)(6) STUDY (START). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL. HOWEVER, THIS PT WAS LATER DETERMINED TO BE INELIGIBLE FOR THE ENROLLMENT IN THE STUDY.

    Description of Event or Problem · 1

    DURING A STROKE PROCEDURE THERE WAS A DISSECTION INVOLVING THE RIGHT ICA AT THE LEVEL OF THE MID CERVICAL. ACCORDING TO THE PRINCIPAL INVESTIGATOR, DR. (B)(6), THE DISSECTION WAS RELATED TO THE STUDY DEVICE, PROBABLY THE 041 CATHETER, BUT HE COULD NOT BE SURE SPECIFICALLY. THERE WAS NO TREATMENT REQUIRED TO ADDRESS THE DISSECTION AND THE EVENT WAS CONSIDERED MILD. THERE WAS NO MENTION OF THE DISSECTION LATER ON IN THE PROCEDURE AND NO COMPLICATIONS TO THE AREA OF THE RIGHT CERVICAL ICA WERE OBSERVED. THE PT WAS REQUIRED TO BEGIN ASPIRIN A DAY EARLIER THAN STANDARD OF CARE AS A RESULT OF THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other