BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER PASSER, DISPOSABLE, 60 CM

    MDR report key: 8219324 · Received January 4, 2019

    Report

    Report Number
    2021898-2019-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2019
    Report Date
    January 4, 2019
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    MAJ
    PMA / PMN Number
    K911382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATED THERE WERE PREVIOUSLY SUBMITTED REPORTS FOR THE "SEVERAL INSTANCES" NOTED IN THIS REGULATORY REPORT. ANY FURTHER INFORMATION RECEIVED WILL BE REPORTED IN ONE OF THE FOLLOWING REPORTS: 2021898-2018-00265 2021898-2018-00373 2021898-2018-00374 2021898-2017-00661 2021898-2018-00466. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE ¿SEVERAL INSTANCES¿ OF THE CATHETER PASSER BREAKING OVER THE ¿PAST YEAR.¿ THE PART THAT WAS BREAKING WAS THE PART WHERE THE CATHETER IS ATTACHED TO THE END OF THE OBTURATOR. IT WAS STATED THIS WOULD SOMETIMES OCCUR WHEN DETACHING THAT END OF THE OBTURATOR FROM THE CATHETER PASSER HANDLE. THE NEUROSURGEON WOULD EITHER REPLACE THE PRODUCT OR MAKE USE OF THE CURRENT PASSER. THERE WERE NO INJURIES ASSOCIATED WITH THE ISSUE. THE PASSERS WERE DISCARDED AND NOT AVAILABLE FOR RETURN. NO FURTHER SPECIFIC EVENT, PATIENT, OR DEVICE INFORMATION WAS AVAILABLE FOR THE REPORTED INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9114 CATHETER PASSER, DISPOSABLE, 60 CM CATHETER, PERCUTANEOUS, INTRASPINAL, SHORT TERM MAJ MEDTRONIC NEUROSURGERY 48409 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1