BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CAT 12 ASPIRATION CATHETER

    MDR report key: 17243956 · Received June 30, 2023

    Report

    Report Number
    3005168196-2023-00313
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 2, 2023
    Report Date
    June 30, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948022553
    PMA / PMN Number
    K210323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT12 CONFIRMED THAT THE CATHETER WAS FRACTURED. IF THE CAT12 IS ADVANCED AGAINST RESISTANCE, DAMAGE SUCH AS A KINK MAY OCCUR. SUBSEQUENTLY, IF A KINKED DEVICE FURTHER MANIPULATED AGAINST RESISTANCE, THE KINK MAY WORSEN TO A FRACTURE. FURTHER EVALUATION REVEALED AN ADDITIONAL FRACTURE. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND THE ROOT CAUSE COULD NOT BE DETERMINED. 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. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERIOR FEMORAL VEIN (SFV) USING A LIGHTNING ASPIRATION TUBING (LIGHTNING), AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH AT THE TARGET LOCATION AND ADVANCED THE GUIDEWIRE THROUGH THE SHEATH. THEN, THE PHYSICIAN ADVANCED THE CAT12 THROUGH THE SHEATH OVER THE GUIDEWIRE. THE GUIDEWIRE WAS REMOVED, AND THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES USING THE CAT12. NEXT, WHILE ATTEMPTING TO COMPLETE A THIRD PASS, THE PHYSICIAN NOTICED THAT THE CAT12 WAS KINKED AT THE MIDSHAFT UNDER FLUOROSCOPY. THE PHYSICIAN BEGAN TO STRAIGHTEN OUT THE CAT12 BY PULLING BACK THE CAT12. WHILE PULLING BACK THE CAT12, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE CAT12 WAS BREAKING APART. NEXT, THE PHYSICIAN WAS ABLE TO PULL THE CAT12 BACK INTO THE SHEATH AND REMOVED THE CAT12 AND THE SHEATH TOGETHER. IT WAS REPORTED THAT THE CAT12 WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255181 INDIGO SYSTEM CAT 12 ASPIRATION CATHETER QEW QEW PENUMBRA, INC. H00001039 00815948022553

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female