BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 11698438 · Received April 20, 2021

    Report

    Report Number
    3005168196-2021-00807
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    November 17, 2020
    Report Date
    March 22, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    PMA / PMN Number
    K163618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 (3331): H10/11 PREVIOUS MDR SUBMISSION INDICATED "THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS." HOWEVER, THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. FURTHERMORE, THIS DEVICE IS NOT AVAILABLE FOR RETURN. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE INDIGO SYSTEM CATRX ASPIRATION CATHETER INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, NEUROLOGICAL DEFICITS INCLUDING STROKE AND OR DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENT WAS AN ANTICIPATED COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE OBTUSE MARGINAL OF THE LEFT CIRCUMFLEX (LCX) USING AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) AND A PENUMBRA ENGINE (ENGINE). NO PROCEDURAL COMPLICATIONS OR DEVICE MALFUNCTIONS WERE REPORTED. THREE DAYS POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE. SUBSEQUENTLY, THE PATIENT WAS ADMINISTERED DUAL ANTIPLATELET THERAPY AND STATIN TO TREAT THE STROKE. AS OF (B)(6) 2021, THE STROKE WAS STILL ONGOING; HOWEVER, THE PATIENT WAS DISCHARGED HOME. THE STROKE WAS ADJUDICATED TO BE A SERIOUS ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO BOTH THE CATRX AND TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589757 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention