BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 7914070 · Received September 27, 2018

    Report

    Report Number
    2648988-2018-00040
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    September 5, 2018
    Report Date
    September 6, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS IS NOT POSSIBLE BECAUSE AT THIS MOMENT, THE COMPLAINT UNIT HAS NOT BEEN RETURNED FOR EVALUATION. DHR FOR LOT 1171250 WAS REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. ALSO, NO EVENT WAS RECORDED FOR THE MENTIONED LOT; THUS, THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE REPORTED CONDITION IS UNCONFIRMED AND THE ROOT CAUSE IS UNDETERMINED UDI NUMBER: (B)(4).

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE ACCOUNT MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT ON (B)(6) 2018, AN INS5010 HERMETIC LUMBAR CATHETER CLOSED TIP BROKE DURING AN UNSPECIFIED PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 07SEP2018 INDICATING THAT THE DOCTOR WAS TRYING TO IMPLANT THE CATHETER INTO THE PATIENT IN THE INTERVENTIONAL RADIOLOGY (IR) SUITE WHEN THE TIP OF THE CATHETER BROKE OFF IN THE PATIENT¿S SPINE. THE TIP WAS LEFT IN PLACE AND A SECOND CATHETER WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO OTHER CLINICAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756808 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR 1171250

    Patients

    Seq Age Sex Outcome Treatment
    1