BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM SEPARATOR 4

    MDR report key: 12782770 · Received November 9, 2021

    Report

    Report Number
    3005168196-2021-02528
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 13, 2021
    Report Date
    January 21, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017594
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT 3005168196-2021-02528: SECTION A. BOX 1. PATIENT IDENTIFIER H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PERONEAL ARTERY, LEFT ANTERIOR TIBIAL ARTERY AND POSTERIOR TIBIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 4 (SEP4), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY REVASCULARIZED THE LEFT PERONEAL ARTERY BY USING THE CATRX AND THE SEP4. AFTERWARDS, THE PHYSICIAN ADVANCED THE CATRX TO THE LEFT ANTERIOR TIBIAL ARTERY WITH THE HELP OF A GUIDEWIRE AND ADVANCED THE SEP4 THROUGH THE CATRX. THE PHYSICIAN ENCOUNTERED RESISTANCE AS THE SEP4 WAS BEING ADVANCED 1-2 CM PAST THE DISTAL END OF THE CATRX DUE TO SIGNIFICANT CHRONIC THROMBUS IN THE VESSEL. AFTER COMPLETING A FEW PASSES, THE PHYSICIAN NOTICED THAT THE SEP4 BULB WAS NOT MOVING ALONG WITH ITS PUSHER WIRE. HE THEN SUCTIONED THE SEP4 BULB TO THE TIP OF THE CATRX. HE RETRACTED THE CATRX WITH ASPIRATION TURNED ON AND WAS ABLE TO REMOVE THE SEP4 AND THE BULB COMPLETELY FROM THE PATIENT'S VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW SEP4 AND THE SAME CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679257 INDIGO SYSTEM SEPARATOR 4 QEX, QEW QEX PENUMBRA, INC. SEPC4 F100671 00814548017594

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male