BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    MDR report key: 11369874 · Received February 23, 2021

    Report

    Report Number
    3005168196-2021-00334
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 13, 2021
    Report Date
    December 30, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548012490
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE RETURNED 3MAXC REVEALED THAT THE DISTAL ATRAUMATIC TIP WAS DAMAGED, AND THE MARKERBAND WAS UNDAMAGED. THIS DAMAGE LIKELY CONTRIBUTED TO THE INABILITY TO ASPIRATE DURING THE PROCEDURE. FURTHER EVALUATION REVEALED STRETCHING ON THE DISTAL SHAFT. IF THE DEVICE IS FORCEFULLY MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS STRETCHING AND DAMAGE TO THE DISTAL TIP MAY OCCUR. MANIPULATION OF THE DEVICE WITHIN THE REPORTED PATIENT¿S TORTUOUS ANATOMY MAY CONTRIBUTE TO RESISTANCE. DURING FUNCTIONAL TESTING, THE 3MAXC WAS CONNECTED TO A DEMONSTRATION ASPIRATION TUBING, CANISTER AND PUMP MAX AND WAS ABLE TO ASPIRATE FLUID AT A SLOW RATE. 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

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT: 3005168196-2021-00334. 1. SECTION B. BOX 1. ADVERSE EVENT AND/OR PRODUCT PROBLEM. 2. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 3. SECTION H. BOX 1. TYPE OF REPORTABLE EVENT. 4. SECTION H. BOX 6. PATIENT CODE 1. 4. SECTION H. BOX 6. PATIENT CODE 2 SHOULD BE BLANK. PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE FOLLOW-UP #01 MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #02 MFR REPORT: 3005168196-2021-00334. 1. SECTION H. BOX 6. CONCLUSIONS CODE 2. 2. SECTION H. BOX 10./11. NARRATIVE/CORRECTED. INTRACRANIAL HEMORRHAGE IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM. EVALUATION OF THE RETURNED 3MAXC REVEALED THAT THE DISTAL ATRAUMATIC TIP WAS DAMAGED, AND THE MARKERBAND WAS UNDAMAGED. THIS DAMAGE LIKELY CONTRIBUTED TO THE INABILITY TO ASPIRATE DURING THE PROCEDURE. FURTHER EVALUATION REVEALED STRETCHING ON THE DISTAL SHAFT. IF THE DEVICE IS FORCEFULLY MANIPULATED AGAINST RESISTANCE, DAMAGE SUCH AS STRETCHING AND DAMAGE TO THE DISTAL TIP MAY OCCUR. MANIPULATION OF THE DEVICE WITHIN THE REPORTED PATIENT¿S TORTUOUS ANATOMY MAY CONTRIBUTE TO RESISTANCE. DURING FUNCTIONAL TESTING, THE 3MAXC WAS CONNECTED TO A DEMONSTRATION ASPIRATION TUBING, CANISTER AND PUMP MAX AND WAS ABLE TO ASPIRATE FLUID AT A SLOW RATE. 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 · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTRACRANIAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC TO THE TARGET VESSEL. THEN, DURING THE FIRST PASS, THE PHYSICIAN USED A 20 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE ASPIRATE ANY THROMBUS. THEREFORE, THE PHYSICIAN REMOVED THE 3MAXC AND NOTICED THAT THE MARKERBAND WAS DEFORMED. THE PHYSICIAN THEN USED A PLASTIC NEEDLE TO RESTORE THE DEFORMED MARKERBAND. AFTERWARDS, THE PHYSICIAN RE-ADVANCED THE 3MAXC TO THE TARGET VESSEL AND USED A 10 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE TO ASPIRATE ANY THROMBUS. THEREFORE, THE 3MAXC WAS REMOVED AND IT WAS NOTICED THAT THE MARKERBAND WAS DEFORMED AGAIN. THE PROCEDURE ENDED AT THIS POINT. DUE TO THE PATIENT¿S AGE AND TORTUOUS ANATOMY, THE PHYSICIAN WANTED TO REDUCE THE RISK OF A HEMORRHAGE COMPLICATION. IT WAS ALSO REPORTED THAT A CT WAS PERFORMED IMMEDIATELY FOLLOWING THE PROCEDURE AND IT SHOWED INTRACRANIAL HEMORRHAGE LESIONS. THE INTRACRANIAL HEMORRHAGE WAS REPORTED TO BE POSSIBLY RELATED TO THE 3MAXC.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTRACRANIAL ARTERY USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE 3MAXC TO THE TARGET VESSEL. THEN, DURING THE FIRST PASS, THE PHYSICIAN USED A 20 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE ASPIRATE ANY THROMBUS. THEREFORE, THE PHYSICIAN REMOVED THE 3MAXC AND NOTICED THAT THE MARKERBAND WAS DEFORMED. THE PHYSICIAN THEN USED A PLASTIC NEEDLE TO RESTORE THE DEFORMED MARKERBAND. AFTERWARDS, THE PHYSICIAN RE-ADVANCED THE 3MAXC TO THE TARGET VESSEL AND USED A 10 ML SYRINGE TO MANUALLY ASPIRATE; HOWEVER, IT WAS NOTICED THAT THE 3MAXC WAS UNABLE TO ASPIRATE ANY THROMBUS. THEREFORE, THE 3MAXC WAS REMOVED AND IT WAS NOTICED THAT THE MARKERBAND WAS DEFORMED AGAIN. THE PROCEDURE ENDED AT THIS POINT. DUE TO THE PATIENT¿S AGE AND TORTUOUS ANATOMY, THE PHYSICIAN WANTED TO REDUCE THE RISK OF A HEMORRHAGE COMPLICATION. IT WAS ALSO REPORTED THAT A CT WAS PERFORMED IMMEDIATELY FOLLOWING THE PROCEDURE AND IT SHOWED INTRACRANIAL HEMORRHAGE LESIONS. THE RELATIONSHIP BETWEEN THE INTRACRANIAL HEMORRHAGE AND THE 3MAXC IS UNKNOWN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266468 PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 3MAXC F86779 00814548012490

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female