BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO SYSTEM CATRX ASPIRATION CATHETER

    MDR report key: 14682466 · Received June 13, 2022

    Report

    Report Number
    3005168196-2022-00283
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 21, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEX
    UDI-DI
    00814548017556
    PMA / PMN Number
    K163618
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT: 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM 2. SECTION D. BOX 1. BRAND NAME 3. SECTION D. BOX 4. LOT # 4. SECTION D. BOX 4. CATALOG # 5. SECTION D. BOX 4. EXPIRATION DATE 6. SECTION D. BOX 4. UNIQUE IDENTIFIER 7. SECTION D. BOX 5. 510(K) # EVALUATION OF THE RETURNED CATRX CONFIRMED FRACTURE ON ITS PROXIMAL SHAFT. THIS IS LIKELY THE REPORTED DISTAL FRACTURE. EVALUATION ALSO REVEALED A KINK AND DAMAGED DISTAL TIP. IF THE DEVICE IS ADVANCED AGAINST RESISTANCE DURING USE, DAMAGE SUCH AS THIS MAY OCCUR. BASED ON THE REPORTED EVENT, THE RESISTANCE WAS LIKELY DUE TO ALREADY PLACED STENT. FURTHER EVALUATION OF THE DEVICE REVEALED A KINK ON THE PROXIMAL END OF THE GUIDEWIRE LUMEN. THIS DAMAGE WAS LIKELY INCIDENTAL TO THE COMPLAINT. 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 SUPERFICIAL FEMORAL ARTERY (SFA), ANTERIOR TIBIAL (AT) ARTERY AND POSTERIOR TIBIAL (PT) ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND THE PATIENT HAD A STENT PLACED IN THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT7. WHILE TORQUEING THE CAT7 DURING THE NEXT PASS; THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE CAT7 WAS REMOVED FROM THE SHEATH. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE CAT7 WAS TWISTED AND BROKEN AT THE DISTAL END, BUT IT WAS CONNECTED. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE A CATRX AND COMPLETED ONE PASS. DURING THE NEXT PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE CATRX WOULD NOT CROSS DUE TO ALREADY PLACED STENT. THEREFORE, THE CATRX WAS REMOVED. UPON REMOVAL, THE DISTAL END OF THE CATRX WAS NOTICED TO BE DAMAGED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA), ANTERIOR TIBIAL (AT) ARTERY AND POSTERIOR TIBIAL (PT) ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 7 (CAT7), AN INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND THE PATIENT HAD A STENT PLACED IN THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY COMPLETED TWO PASSES IN THE TARGET VESSEL USING THE CAT7. WHILE TORQUEING THE CAT7 DURING THE NEXT PASS; THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE CAT7 WAS REMOVED FROM THE SHEATH. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO USE A CATRX AND COMPLETED ONE PASS. DURING THE NEXT PASS, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE CATRX WOULD NOT CROSS DUE TO ALREADY PLACED STENT. THEREFORE, THE CATRX WAS REMOVED. UPON REMOVAL, THE DISTAL END OF THE CATRX WAS NOTICED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW CATRX. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582947 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. F110082 00814548017556
    263266 INDIGO SYSTEM CATRX ASPIRATION CATHETER QEX,QEW QEX PENUMBRA, INC. F110082 00814548017556

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male