BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LARGE STYLE VENTRICULAR CATHETER SET

    MDR report key: 7113708 · Received December 13, 2017

    Report

    Report Number
    2648988-2017-00053
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    November 8, 2017
    Report Date
    November 20, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K961113
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 01/12/2018. EVENT AND NON-CONFORMANCE LOGS WERE REVIEWED FOR THE MENTIONED LOT AND DID NOT REVEAL ANYTHING THAT COULD CAUSE THE REPORTED EVENT. NO EVENTS AND/OR REWORK WERE RECORDED FOR THE MENTIONED LOT. LOT NUMBER: 1170832. CATALOG NUMBER: INS4500. MANUFACTURING DATE: MARCH 21, 2017. THE CLIENT REPORTED THAT THE SAMPLE AND THREE (3) OTHERS THEY HAD IN STOCK WERE "DISCARDED." NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR LOT 1170832. IT IS NOT CLEAR IF THIS HAPPENED DURING INSERTION WHERE IT MAY HAVE BEEN PULLED BACK TO REDIRECT OR RETARGET OR IF IT WAS BEING REMOVED SOMETIME AFTER IMPLANTATION. IF DURING IMPLANTATION PROCEDURE, THE IFU PROVIDES THE FOLLOWING WARNING: ¿TO AVOID POSSIBLE TRANSECTION OF THE LUMBAR CATHETER, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE AND CATHETER (WITH GUIDE WIRE IF USED) MUST BE REMOVED SIMULTANEOUSLY.¿ ACCORDING TO THE ATTENDING DOCTOR¿S EXPERT OPINION, ¿THE FRACTURE OF INS 4500 WAS NOT RELATED TO THE TUBING OR THE PRODUCT ITSELF. HE BELIEVES THAT THE FRACTURE OF THE PRODUCT WAS DIRECTLY RELATED TO THE BONY PROMINENCE THAT EXISTED IN THE SKULL.¿ THE MOST PROBABLE CAUSE FOR THIS EVENT IS RELATED TO THE BONY PROMINENCE THAT EXISTED IN THE PATIENT¿S SKULL AS STATED BY THE ATTENDING DOCTOR.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW OF REPORTED LOT DID NOT REVEAL ANY DEVIATION/ANOMALIES THAT COULD CAUSE THE REPORTED CONDITION. NO EVENT WAS GENERATED FOR THE MENTIONED LOT; THEREFORE, THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    N/A.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE EVD FRACTURED UPON REMOVAL FROM A (B)(6) FEMALE PATIENT. THE SURGEON LEFT THE FRACTURED PART OF THE INS4500 IN THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS GETTING A SHUNT INSERTED WEEKS LATER AND AFTER A CT OF THE PATIENT¿S HEAD WAS TAKEN, THE FRACTURED PART OF THE PRODUCT WAS IDENTIFIED. AS THE DOCTOR IMPLANTED THE SHUNT, HE WAS ABLE TO RETRIEVE THE FRACTURED PART OF THE INS4500 AS A BYPRODUCT OF THE SHUNT PLACEMENT. THE DOCTOR SAID THAT THE FRACTURE OF INS4500 WAS NOT RELATED TO THE TUBING OR THE PRODUCT ITSELF. THE DOCTOR BELIEVES THAT THE FRACTURE OF THE PRODUCT WAS DIRECTLY RELATED TO THE BONY PROMINENCE THAT EXISTED IN THE SKULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894129 HERMETIC LARGE STYLE VENTRICULAR CATHETER SET N/A JXG INTEGRA NEUROSCIENCES PR 1170832

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other