BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM JET7 REPERFUSION CATHETER

    MDR report key: 9406501 · Received December 3, 2019

    Report

    Report Number
    3005168196-2019-02221
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 3, 2019
    Report Date
    November 5, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948020962
    PMA / PMN Number
    K190010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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:3005168196-2019-02221. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM RESULTS: THE JET7 WAS STRETCHED APPROXIMATELY 116.5 THRU 119.5, 122.0 THRU 126.5 AND 129.0 THRU 131.0 CM FROM THE HUB. CONCLUSIONS: EVALUATION OF THE RETURNED JET7 REVEALED THAT THE CATHETER WAS STRETCHED. IF THE CATHETER IS FORCEFULLY MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS STRETCHING MAY OCCUR. DURING DECONTAMINATION, THE JET7 WAS FLUSHED AND THERE WAS NO OBSERVATION OF THE DISTAL TIP OF THE CATHETER EXPANDING. THEREFORE, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO OTHER DEVICES ASSOCIATED WITH THE COMPLAINT WERE RETURNED FOR EVALUATION. PENUMBRA CATHETERS ARE VISUALLY 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 · 0

    THE PATIENT UNDERWENT A THROMECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA STENT RETRIEVER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SOME RESISTANCE WHILE ADVANCING THE JET7 THROUGH THE TUOHY; HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ADVANCE THE JET7 INTO THE TARGET VESSEL. THE PHYSICIAN PROCEEDED TO MAKE FOUR PASSES USING ONLY THE JET7 AND TWO PASSES USING THE JET7 AND THE STENT RETRIEVER TOGETHER. THE JET7 WAS THEN REMOVED AND FLUSHED ON THE BACK TABLE. WHILE FLUSHING THE JET7, IT WAS NOTED THAT THE DISTAL TIP EXPANDED. THEREFORE, THE JET7 WAS REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7, THE SAME STENT RETRIEVER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    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 · 1

    THE PATIENT UNDERWENT A THROMECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JET 7 REPERFUSION CATHETER (JET7), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA STENT RETRIEVER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SOME RESISTANCE WHILE ADVANCING THE JET7 THROUGH THE TUOHY; HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY ADVANCE THE JET7 INTO THE TARGET VESSEL. THE PHYSICIAN PROCEEDED TO MAKE FOUR PASSES USING ONLY THE JET7 AND TWO PASSES USING THE JET7 AND THE MICROCATHETER TOGETHER. THE JET7 WAS THEN REMOVED AND FLUSHED ON THE BACK TABLE. WHILE FLUSHING THE JET7, IT WAS NOTED THAT THE DISTAL TIP EXPANDED. THE PROCEDURE WAS COMPLETED USING ANOTHER JET7 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
    1197045 PENUMBRA SYSTEM JET7 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F90971 00815948020962

    Patients

    Seq Age Sex Outcome Treatment
    1