BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURON MAX 6F 088 LONG SHEATH

    MDR report key: 7197873 · Received January 16, 2018

    Report

    Report Number
    3005168196-2018-00147
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 8, 2017
    Report Date
    December 21, 2017
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DQY
    PMA / PMN Number
    K111380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: TO (B)(6) 2017. RESULTS: THE RETURNED PIECE WAS A 3MM PIECE OF EXTRUSION FROM THE NEURON MAX. CONCLUSIONS: THE FINAL CONCLUSIONS OF THE DEVICE INVESTIGATION ARE AS FOLLOWS: EVALUATION OF THE RETURNED FRAGMENT OF THE DEVICE REVEALED THAT A PIECE OF THE NEURON MAX WAS FRACTURED FROM THE CATHETER SHAFT. INSPECTION OF THE FRACTURE REVEALED THAT IT DID NOT OCCUR AT A MATERIAL JUNCTION. FURTHER EVALUATION OF THE FRACTURED DISTAL PIECE SHOWS THAT THE EXTRUSION WAS PROPERLY LAMINATED OVER THE MARKER BAND. THE ROOT CAUSE OF THIS DAMAGE COULD NOT BE DETERMINED. PENUMBRA CATHETERS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX. DURING THE PROCEDURE, A PIECE BROKE OFF OF THE NEURON MAX AND MIGRATED, OCCLUDING THE MCA. THE PATIENT PASSED AWAY A FEW DAYS LATER IN THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE MIDDLE CEREBRAL ARTERY (MCA) USING A NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, WHILE USING A NON-PENUMBRA CATHETER WITHIN THE NEURON MAX, A PIECE OF THE TIP OF THE NEURON MAX BROKE OFF AND MIGRATED, OCCLUDING THE MCA; HOWEVER, THE BROKEN TIP OF THE NEURON MAX WAS NOT NOTICED UNTIL AN X-RAY WAS PERFORMED THE NEXT DAY. THE PATIENT PASSED AWAY IN THE HOSPITAL FROM BRONCHOPNEUMONIA A FEW DAYS LATER. THE EXACT DATE THAT THE PROCEDURE TOOK PLACE, DURING WHICH THE DISTAL TIP OF THE NEURON MAX BROKE OFF AND MIGRATED, IS UNKNOWN; HOWEVER, THE PHYSICIAN STATED THAT THE PATIENT DIED OF BRONCHOPNEUMONIA ON (B)(6) 2017, AFTER A FEW DAYS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40539 NEURON MAX 6F 088 LONG SHEATH DQY DQY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L