BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 6

    MDR report key: 6133657 · Received November 29, 2016

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    Report

    Report Number
    3005168196-2016-01766
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 4, 2016
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548016245
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE INDIGO SYSTEM ASPIRATION CATHETER 6 (CAT6) WAS KINKED AND OVALIZED IN MULTIPLE LOCATIONS THROUGHOUT ITS LENGTH (FIGURE 1) AND HAD MULTIPLE CONSECUTIVE KINKS IN THE DISTAL SHAFT. CONCLUSIONS: EVALUATION OF THE RETURNED DEVICE REVEALED IT WAS KINKED AND OVALIZED IN MULTIPLE LOCATIONS. THIS TYPE OF DAMAGE TYPICALLY OCCURS DUE TO REPEATED FORCEFUL MANIPULATION OF THE CAT6 AGAINST RESISTANCE DURING INSERTION INTO A SHEATH. THE ROOT CAUSE OF THE INITIAL RESISTANCE EXPERIENCED BY THE PHYSICIAN COULD NOT BE DETERMINED. THE SECOND CAT6 AND THE NON-PENUMBRA SHEATH USED IN THE PROCEDURE WERE NOT RETURNED FOR EVALUATION. PENUMBRA CATHETERS ARE 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBERS: 3005168196-2016-01767.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING INDIGO SYSTEM ASPIRATION CATHETERS 6 (CAT6). DURING THE PROCEDURE, WHILE ATTEMPTING TO INSERT A CAT6 INTO A 6F DESTINATION SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE CAT6 BECAME KINKED JUST BEHIND THE TIP; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO USE A NEW CAT6; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN AND THE CAT6 BECAME KINKED. THE KINKED CAT6 WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW CAT6 AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783928 INDIGO SYSTEM ASPIRATION CATHETER 6 DXE DXE PENUMBRA, INC. F69157 00814548016245

    Patients

    Seq Age Sex Outcome Treatment
    1