BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER D

    MDR report key: 6843064 · Received September 5, 2017

    Report

    Report Number
    3005168196-2017-01489
    Event Type
    Malfunction
    Date Received
    September 5, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 8, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    UDI-DI
    00814548017624
    PMA / PMN Number
    K160533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE FOLLOW-UP #01 AND IS BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT: 1. 510(K). ADDITIONAL 510(K) #S THAT ALSO APPLY TO THIS COMPLAINT: K142870. K161523.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 1. 510(K).

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE INDIGO SYSTEM ASPIRATION CATHETER D (CATD) WAS KINKED APPROXIMATELY 47.0 CM FROM THE PROXIMAL HUB. CONCLUSIONS: EVALUATION OF THE RETURNED CATD CONFIRMED A KINK ON ITS DISTAL END. THIS KINK WAS TWISTED SUPPORTING THE CLAIM THAT IT OCCURRED WHEN THE PHYSICIAN ROTATED THE CATHETER. IF THE DISTAL END OF THE CATHETER IS WITHIN THROMBUS FILLED ANATOMY IT MAY HAVE HOLD THE TIP IN PLACE ENOUGH TO KINK WHEN IT IS TORQUED ON THE PROXIMAL END. 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.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT SUBCLAVIAN AND BRACHIOCEPHALIC VEIN TO TREAT A STENOSIS IN THE SUPERIOR VENA CAVA (SVC) USING INDIGO SYSTEM ASPIRATION CATHETERS D (CATDS). DURING THE PROCEDURE, THE PHYSICIAN ACCESSED THE RIGHT BASILIC VEIN WITH A NON-PENUMBRA 8F SHEATH, THEN ADVANCED THE CATD IN THE TARGET VESSEL. IT WAS REPORTED THAT AFTER A FEW SUCCESSFUL ADVANCES AND RETRACTIONS WITH THE CATD, THE CATD BECAME KINKED AS THE PHYSICIAN WAS TORQUING THE CATHETER AND THAT THE KINK BECAME MORE PRONOUNCED AS THE PHYSICIAN ROTATED THE CATD. THEREFORE, THE PHYSICIAN DECIDED TO WITHDRAW THE CATD; HOWEVER, UPON RETRACTION, THE TWISTED SEGMENT BECAME CAUGHT AT THE TIP OF THE SHEATH. CONSEQUENTLY, RESISTANCE WAS ENCOUNTERED BUT NOT MUCH EXTRA FORCE WAS REQUIRED TO WITHDRAW ENTIRE CATD. AFTER THAT, THE PHYSICIAN UPSIZED THE SHEATH TO A 9F NON-PENUMBRA SHEATH AND COMPLETED THE PROCEDURE USING A SECOND CATD WITHOUT FURTHER ISSUES. IT WAS ALSO REPORTED THAT THE PATIENT ANATOMY WAS NOT VERY TORTUOUS BUT PERHAPS THE CATD DISTAL SEGMENT MAY HAVE HAD FRICTION FROM THE STENOTIC AREA AND THE PATENT SECTION IN A BEND ALLOWED FOR THE CATHETER TO BEND/KINK. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623506 INDIGO SYSTEM ASPIRATION CATHETER D DXE DXE PENUMBRA, INC. F74426 00814548017624

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR