BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM SEPARATOR 054

    MDR report key: 1760645 · Received July 14, 2010

    Report

    Report Number
    3005168196-2010-00532
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Report Date
    June 18, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM COULD NOT BE DETERMINED. VESSEL PERFORATION AND DISSECTION ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES ARE NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    THE PT HAD A CARDIO ANGIOGRAM AND NEEDED BYPASS SURGERY. THE PT HAD BLOWN OUT THE APEX OF THE HEART. DURING ANGIO, A CLOT FROM THE AORTIC ARCH BROKE OFF AND WENT INTO THE DISTAL CAROTID ARTERY. THE PT WAS PLACED ON A BALLOON PUMP AND AFTER MUCH DELIBERATION THEY FULLY HEPARINIZED THE PT. THE PHYSICIAN NOTIFIED THE FAMILY THAT THE PROGNOSIS WAS NOT GOOD. DURING THE MECHANICAL THROMBECTOMY PROCEDURE, THE PHYSICIAN BROUGHT THE TIP OF THE PSC054 UP THE ICA TO THE DISTAL PORTION THROUGH A 7F SHUTTLE SHEATH. THERE WAS A HARD FIBROUS CLOT IN A 4 MM VESSEL THAT WAS TOTALLY OCCLUDED. THE CLOT WAS DESCRIBED AS A FIBROUS CLOT THAT CAME FROM THE HEART. THE SEPARATOR WAS PUT INTO THE PSC504 AND THEN MOVED INTO THE CLOT. THE SEPARATOR KEPT GOING LATERAL TO THE CLOT WHICH WAS THE SAME SIZE AS THE VESSEL. AFTER ABOUT 30 MINUTES OF ASPIRATION WITHOUT SUCCESS, THE PHYSICIAN STARTED TO GET MORE AGGRESSIVE AND AFTER ABOUT 50 MINUTES HE SAW A PERFORATION OF THE CAROTID ARTERY. THE PHYSICIAN BELIEVES HE PERFORATED WITH THE SEPARATOR. HE THEN PLACED SIX COILS TO CLOSE THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 054 PERCUTANEOUS CATHETER DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention