BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    MDR report key: 20894163 · Received December 10, 2024

    Report

    Report Number
    3005168196-2024-00409
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    December 27, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948023970
    PMA / PMN Number
    K210083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED CAT7D CONFIRMED A FRACTURE. EVALUATION REVEALED SIGNS OF KINKING AND TORQUING AT THE FRACTURE SITE. BASED ON THE REPORTED EVENT, THE CAT7D WAS TORQUED UNRESTRAINED AGAINST RESISTANCE AFTER A FEW SUCCESSFUL PASSES DURING THE PROCEDURE. IF THE CAT7D IS TORQUED UNRESTRAINED AGAINST RESISTANCE, DAMAGE SUCH AS A FRACTURE MAY OCCUR. FURTHER EVALUATION REVEALED A KINK ON THE MIDSHAFT AND MULTIPLE OVALIZATIONS ALONG THE LENGTH. THIS DAMAGE WAS INCIDENTAL TO THE COMPLAINT AND LIKELY OCCURRED DURING REMOVAL OF THE DEVICE. SOME OF THIS DAMAGE MAY HAVE OCCURRED DURING PACKAGING FOR RETURN TO PENUMBRA. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K) THAT ALSO APPLIES TO THIS COMPLAINT: K193595. THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT A FISTULA USING AN INDIGO SYSTEM ASPIRATION CATHETER 7D (CAT7D) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN COMPLETED A FEW PASSES USING THE CAT7D. NEXT, THE PHYSICIAN OVER TORQUED THE CAT7D AND SUBSEQUENTLY NOTICED UNDER FLUOROSCOPY THAT THE CAT7D FRACTURED AT THE MID-SHAFT IN THE PATIENT'S ARM. THE PHYSICIAN THEN REMOVED THE FRACTURED PART OF THE CAT7D USING A SNARE DEVICE AND ADDITIONALLY PERFORMED A CUT DOWN TO ACCOMMODATE THE CATHETER COMING OUT OF THE VESSEL AND INSERTED A NEW SHEATH TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2502917 INDIGO SYSTEM ASPIRATION CATHETER 7D QEW QEW PENUMBRA, INC. H00004319 00815948023970

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male