BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM SEPARATOR 7D

    MDR report key: 15414465 · Received September 13, 2022

    Report

    Report Number
    3005168196-2022-00427
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    August 16, 2022
    Report Date
    October 11, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023994
    PMA / PMN Number
    K193595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)# THAT ALSO APPLY TO THIS COMPLAINT: K210083. THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND IS BEING UPDATED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2022-00427. 1. SECTION H. BOX 6. DEVICE CODE 2. EVALUATION OF THE RETURNED SEP7D CONFIRMED THAT THE TIP DISTAL TO THE BULB WAS FRACTURED OFF THE DELIVERY WIRE. IF THE SEP7D IS REPEATEDLY MANIPULATED THROUGH TOUGH CLOT BURDEN, THE DISTAL TIP MAY BECOME FATIGUED AND DAMAGE SUCH AS THIS MAY OCCUR. THE FRACTURED DISTAL TIP WAS NOT RETURNED FOR EVALUATION. PENUMBRA COILS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    HOLD FOR MB 10.13 THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE BRACHIAL ARTERY USING AN INDIGO SYSTEM SEPARATOR 7 D (SEP7 D) AND AN INDIGO SYSTEM ASPIRATION CATHETER 7 D (CAT7 D). DURING THE PROCEDURE, AFTER COMPLETING THE FIRST PASS, THE PHYSICIAN REMOVED THE CAT7 D AND SEP7 D AND NOTICED UNDER FLUOROSCOPY THAT THE WIRE DISTAL TO THE BULB OF THE SEP7 D HAD MIGRATED FROM THE PATIENT''S ARM INTO THE LUNG. THE PROCEDURE ENDED AT THIS POINT AND NO FURTHER INTERVENTION WAS PERFORMED TO REMOVE THE FOREIGN BODY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391898 INDIGO SYSTEM SEPARATOR 7D QEW QEW PENUMBRA, INC. H12300 00815948023994

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Female