BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROVENT-PTO 2L

    MDR report key: 3911536 · Received June 5, 2014

    Report

    Report Number
    3006942548-2014-00001
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    RAUMEDIC AG
    Product Code
    GWM
    PMA / PMN Number
    K130529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RAUMEDIC RECEIVED THE INFORMATION AS NOTED ABOVE AND IMMEDIATELY INITIATED A RISK ASSESSMENT AND ROOT CAUSE ANALYSIS. THE EVALUATION TEAM INCLUDED (B)(4). THIS EVALUATED HAD TO BE CONDUCTED WITHOUT THE ABILITY TO EXAMINE THE DEVICE, BUT RAUMEDIC WAS ABLE TO REVIEW THE REPORTED INCIDENT AND FILMS. WE LEARNED THAT CONTRARY TO EXPLICIT LABELING INSTRUCTIONS AND CUSTOMARY PRACTICE, A STAFF MEMBER ATTEMPTED TO REMOVE THE CATHETER WITHOUT FIRST LOOSENING THE SUTURES. IN THE ATTEMPTS TO EXPLANT THE CATHETER, THE CATHETER WAS APPARENTLY PULLED WITH UNDUE FORCE. THE COMBINED EFFECT OF NOT LOOSENING THE BURR HOLE SUTURES AND PULLING THE CATHETER WITH EXCESSIVE FORCE ARE INCONSISTENT WITH THE LABELING AND THE IFU (REV9), A COPY OF WHICH IS ENCLOSED WITH THE CATHETER.

    Description of Event or Problem · 1

    (B)(6) 2014, USER FACILITY STAFF CONTACTED RAUMEDIC SALES REPRESENTATIVE BY PHONE AND RELATED THE FOLLOWING INFORMATION. ON (B)(6) 2014 A NEUROSURGEON INSERTED A NEUROVENT-PTO 2L CATHETER IN A (B)(6) MONTH OLD PATIENT. THE SURGEON TUNNELED THE CATHETER, USING A CH9 DRILL, MAKING A 30 DEGREE BURR HOLE. ON (B)(6) 2014, A STAFF NURSE ATTEMPTED TO REMOVE THE CATHETER AND WHILE PULLING THE CATHETER FROM THE EXIT SLIT, SHE FELT RESISTANCE. THE NURSE CONTACTED THE NEUROSURGEON WHO SUGGESTED THAT SHE OPEN THE SUTURES AND REPORTED THAT THERE WAS NO CATHETER IN THE BURR HOLE. SHE MASSAGED THE SCALP AND WAS ABLE TO REMOVE THE CATHETER. WHEN THE CATHETER CAME OUT, THERE WAS NO TIP AND WIRES EXPOSED. THE NEUROSURGEON WAS CONTACTED AGAIN AND THE HOSPITAL PERFORMED A CT SCAN. THE SCAN REVEALED THE LOCATION OF THE CATHETER TIP. THE NURSE FORWARDED PICTURES OF THE CATHETER AND THE CT SCAN SHOWING THE TIP THAT WAS LEFT IN THE PATIENT. (B)(6) 2014: ADDITIONAL INFORMATION FROM HOSPITAL ARRIVED BY EMAIL DATED (B)(6): INFORMING RAUMEDIC THAT AN MRI PERFORMED AFTER SURGERY INDICATES THAT THERE ARE NO RESIDUAL PIECES OF THE CATHETER REMAINING IN THE PATIENT. IN ADDITION, THE PROCEDURE TO RETRIEVE THE CATHETER TIP DID NOT APPEAR TO HAVE ANY ADVERSE EFFECTS ON THE PATIENT. RAUMEDIC BELIEVES THAT THE FAILURE TO LOOSEN SUTURES BEFORE ATTEMPTING TO REMOVE THE CATHETER WAS THE CAUSE OF THE EVENT DESCRIBED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328714 NEUROVENT-PTO 2L NEUROLOGICAL CATHETER GWM RAUMEDIC AG 095108-002 E8202166

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention