BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER

    MDR report key: 19059740 · Received April 8, 2024

    Report

    Report Number
    3005168196-2024-00126
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    March 10, 2024
    Report Date
    May 12, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00815948023949
    PMA / PMN Number
    K211654
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    ADDITIONAL DEVICE CODE 4: 2976. 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: 3005168196-2024-00126. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM EMBOLI IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE PENUMBRA SYSTEM. EVALUATION OF THE RETURNED RED72 CONFIRMED A FRACTURE. A KINK AND UNRAVELED INTERNAL COIL WINDS WERE PRESENT AT THE FRACTURED LOCATION. IF THE RED72 IS ADVANCED AGAINST RESISTANCE DURING USE, DAMAGE SUCH AS A KINK MAY OCCUR. THIS KINK MAY HAVE CONTRIBUTED TO THE RESISTANCE EXPERIENCED DURING RETRACTION OF THE RED72 THROUGH THE NEURON MAX AND THE KINK SUBSEQUENTLY WORSENED TO A FRACTURE DURING REMOVAL. BASED ON THE REPORTED EVENT, THE ROOT CAUSE OF THE RESISTANCE DURING ADVANCEMENT COULD NOT BE DETERMINED. FURTHER EVALUATION REVEALED KINKS ALONG THE LENGTH OF THE RED72. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT. THE KINKS ON THE DISTAL FRACTURED SEGMENT LIKELY OCCURRED DURING SNARING AND REMOVAL OF THE DISTAL FRACTURED SEGMENT FROM THE PATIENT¿S BODY. THE KINKS ON THE PROXIMAL FRACTURED SEGMENT 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.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER THE MICROCATHETER THROUGH THE NEURON MAX TO THE TARGET LOCATION. THE MICROCATHETER WAS THEN REMOVED. WHILE ATTEMPTING TO ADVANCE THE RED72 CLOSER TO THE CLOT, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE DISTAL LENGTH OF THE RED72. WHILE ATTEMPTING TO RETRACT THE RED72 INTO THE NEURON MAX TO RELIEVE THE SLACK ON THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RED72 APPEARED TO GET STUCK WITHIN THE NEURON MAX. IT WAS THEN OBSERVED UNDER FLUOROSCOPY THAT THE RED72 FRACTURED AND BEGAN TO UNRAVEL AT THE LOCATION OF THE KINK. WHILE REMOVING THE RED72 AND NEURON MAX TOGETHER, THE FRACTURED SEGMENT OF THE RED72 DETACHED IN THE AORTA. THE PHYSICIAN THEN MADE A CONTRALATERAL ACCESS AND USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE FRACTURED SEGMENT OF THE RED72. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND ANOTHER SHEATH.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT INTERNAL CAROTID ARTERY (ICA) USING A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72), A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX), A NON-PENUMBRA MICROCATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE RED72 OVER THE MICROCATHETER THROUGH THE NEURON MAX TO THE TARGET LOCATION. THE MICROCATHETER WAS THEN REMOVED. WHILE ATTEMPTING TO ADVANCE THE RED72 CLOSER TO THE CLOT, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE DISTAL LENGTH OF THE RED72. WHILE ATTEMPTING TO RETRACT THE RED72 INTO THE NEURON MAX TO RELIEVE THE SLACK ON THE RED72, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RED72 APPEARED TO GET STUCK WITHIN THE NEURON MAX. IT WAS THEN OBSERVED UNDER FLUOROSCOPY THAT THE RED72 FRACTURED AND BEGAN TO UNRAVEL AT THE LOCATION OF THE KINK. WHILE REMOVING THE RED72 AND NEURON MAX TOGETHER, THE RED72 FRACTURED. THE PHYSICIAN THEN MADE A CONTRALATERAL ACCESS AND USED A SNARE DEVICE TO SUCCESSFULLY REMOVE THE FRACTURED SEGMENT OF THE RED72. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER AND ANOTHER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95627 PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. H00003737 00815948023949

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Required Intervention