BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUBY COIL

    MDR report key: 5342402 · Received January 4, 2016

    Report

    Report Number
    3005168196-2016-00013
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    PENUMBRA, INC.
    Product Code
    HCG
    UDI-DI
    00814548013251
    PMA / PMN Number
    K120330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 1. 3005168196-2016-00012; 2. 3005168196-2016-00014; 3. 3005168196-2016-00015. THE HOSPITAL DISPOSED OF THE DEVICE.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING RUBY COILS AND PX SLIM DELIVERY MICROCATHETERS (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PX SLIM IN THE TARGET VESSEL THROUGH ANOTHER MANUFACTURER'S GUIDE CATHETER. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE A RUBY COIL THROUGH THE PX SLIM AND THEY WERE BOTH REMOVED FROM THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PX SLIM'S THROUGH A GUIDE CATHETER AND ANOTHER MANUFACTURER'S CATHETER BUT BOTH PX SLIM DEVICES WOULD NOT ADVANCE COMPLETELY OUT OF THE CATHETERS AND WERE REMOVED. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT. IT IS UNKNOWN IF THERE WAS ANY ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938 RUBY COIL HCG, KRD HCG PENUMBRA, INC. F63004 00814548013251

    Patients

    Seq Age Sex Outcome Treatment
    1