BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2564751 · Received May 8, 2012

    Report

    Report Number
    3005168196-2012-00147
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    March 24, 2012
    Report Date
    April 26, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICES DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT EXPERIENCED ACUTE CEREBRAL INFARCTION. THE PATIENT'S TICI SCORE WAS 0. THE CLOT IN THE DISTAL RIGHT INTERNAL CAROTID ARTERY (ICA) WAS ASPIRATED. THE SEPARATOR 032 KINKED WHEN IT WAS USED IN THE M2 WITHOUT A GUIDE WIRE. THE PHYSICIAN REPLACED THE SEPARATOR 032. THE PHYSICIAN THEN ADMINISTERED T-PA IN AN ARTERIAL INFUSION. THE CLOT IN THE M2 WAS ASPIRATED WITH THE PENUMBRA SYSTEM. THE M2 WAS RE-OPENED. THE PATIENT'S TICI SCORE WAS THEN IIB. THE POSTOPERATIVE CT IMAGE REVEALED SUBARACHNOID HEMORRHAGE (SAH) IN THE RIGHT LATERAL SULCUS. NO ADDITIONAL TREATMENT WAS ADMINISTERED AND THE PATIENT HAD A GOOD PROGNOSIS. THE PHYSICIAN COMMENTED THAT THE SAH IN THE RIGHT LATERAL SULCUS WAS CONFIRMED WITH CT AND THAT HE CONSIDERED THAT THE SEPARATOR 032 MAY HAVE PERFORATED THE M2 WHEN IT WAS USED WITHOUT THE GUIDE WIRE. FORTUNATELY, THE SAH WAS ASYMPTOMATIC. ADDITIONAL INFORMATION ABOUT THE PROCEDURE PROVIDED ON (B)(4) 2012: THE PHYSICIAN FOUND THE CLOT IN THE M2 AFTER USE OF THE REPERFUSION CATHETER 054 TO ASPIRATE CLOT IN THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE REPERFUSION CATHETER AND SEPARATOR 032 WERE USED TO APPROACH THE M2 WITHOUT THE USE OF A GUIDE WIRE. THUS, THE PHYSICIAN WAS USING THE SEPARATOR 032 AS A NEUROVASCULAR GUIDE WIRE. THEN THE SEPARATOR 032 KINKED. THE PHYSICIAN REPLACED THE SEPARATOR FOR A NEW ONE BUT IT ALSO KINKED. THE KINKED SEPARATOR 032 WAS WITHDRAWN AND T-PA WAS ADMINISTERED THROUGH ARTERIA INFUSION. AFTER THE FIRST SEPARATOR 032 KINKED, IT WAS REPLACED WITH ANOTHER SEPARATOR WHICH ALSO KINKED. THIS REPORT IS IN REGARDS TO THE SECOND SEPARATOR. THIS REPORT IS ASSOCIATED WITH MDR 3005168196-2012-00131.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F24277

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR