BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLUX CONTROL PERITONEAL CATHETER, 120CM

    MDR report key: 6549072 · Received May 5, 2017

    Report

    Report Number
    2648988-2017-00013
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Date of Event
    March 26, 2017
    Report Date
    April 14, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    PRE-AMEND
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 15MAY2017 WITH THE FOLLOWING: A (B)(6) FEMALE PATIENT HAD THE DEVICE IMPLANTED (IMPLANT DATE OF AFTER (B)(6) 2016). THE PATIENT HAD ABDOMINAL CATHETER SURGERY AND IT WAS STATED THAT THE DEVICE WAS SUITABLE FOR THAT SURGERY. ON (B)(6) 2017, IT WAS DISCOVERED THAT CSF STOPPED FLOWING BY THE MEDICAL IMAGE DIAGNOSIS SYSTEM. THAT SAME DAY, THE PATIENT HAD A RE-OPERATION AND THE CATHETER WAS REMOVED AND REPLACED. PATIENT OUTCOME WAS REPORTED AS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 05/26/2017. METHOD: DEVICE HISTORY REVIEW. TREND ANALYSIS. FAILURE ANALYSIS. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1160354 WAS REVIEWED. LOT NUMBER: 1160354; CATALOG NUMBER: NL850-1375 (B)(4); MANUFACTURING DATE: FEBRUARY 15, 2016; EXPIRATION DATE: FEBRUARY 28, 2021. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM APRIL 2015 TO APRIL 2017, THERE IS ONLY THIS COMPLAINT REGARDING CSF STOP FLOWING. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS (B)(4). ONE (1) BAG WAS RECEIVED CONTAINING ONE CATHETER. THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND TO BE IN GOOD CONDITION. A VERIFICATION OF PATENCY WAS PERFORMED USING A SYRINGE AND COLORED WATER (COLORED FOR VISUAL PURPOSES). WATER WAS PASSED THROUGH THE CATHETER AND WATER FLOWED WITHOUT ANY RESISTANCE. THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO UNUSUAL EVENT RELATED TO THE REPORTED FAILURE WAS NOTICED DURING THE RECORDS REVIEW OF THIS LOT. THIS DEVICE WAS IMPLANTED ¿AFTER (B)(6) 2016¿ AND THE DATE OF INCIDENT WAS ON (B)(6) 2017; THUS, THE DEVICE WAS FUNCTIONAL FOR ABOUT FOUR (4) MONTHS. IFU STATES THAT THERE ARE DIFFERENT FACTORS (LISTED BELOW) THAT MAY OBSTRUCT THE PERITONEAL CATHETER WHICH ARE NOT RELATED TO CATHETER¿S QUALITY. FLUID FLOW SHOULD HAVE BEEN VERIFIED IMMEDIATELY PRIOR TO IMPLANTATION; THEREFORE, IT IS ASSUMED THAT THE CATHETER WAS PATENT OR UNOBSTRUCTED PRIOR TO USE. THE PRODUCT¿S DIRECTIONS FOR USE STATE THE FOLLOWING: INSTRUCTIONS FOR USE: ¿THE FOLLOWING PROCEDURE IS RECOMMENDED TO VERIFY CATHETER AND SLIT PATENCY PRIOR TO IMPLANTATION. IT SHOULD BE PERFORMED AT THE TIME OF SURGERY. USING A STERILE SYRINGE WITH A BLUNT 17-GAUGE NEEDLE, INSERT THE NEEDLE INTO THE PROXIMAL END OF THE CATHETER. GENTLY FLUSH THE CATHETER WITH STERILE ISOTONIC SALINE SOLUTION. (WE RECOMMEND PHYSIOLOGICAL SALINE.) ALL SLITS SHOULD ALLOW FLUID TO FLOW FREELY¿ IT MAY BE NECESSARY TO GENTLY ROLL THE SLIT SEGMENT OF THE CATHETER BETWEEN THE THUMB AND FOREFINGER TO ESTABLISH FREE FLOW THROUGH ALL THE SLITS. (OCCASIONALLY THE STERILIZATION PROCESS WILL CAUSE THE LIPS OF THE SLITS TO ADHERE SLIGHTLY.) THE SLITS ARE COATED WITH LUBRICANT TO MINIMIZE ADHERENCE DURING STORAGE AND SHOULD NOT BE FLUSHED WITH ANY SOLUTION UNTIL PATENCY IS TESTED IMMEDIATELY PRIOR TO IMPLANTATION. AFTER THE SLITS AND CATHETER PATENCY ARE CONFIRMED, VISUALLY EXAMINE THE SLITS FOR ALIGNMENT. IT IS POSSIBLE THAT EXCESSIVE SYRINGE PRESSURE OR HANDLING MAY TEMPORARILY DEFORM THE NORMAL ALIGNMENT. USE GENTLE FINGER PRESSURE TO REALIGN THE SLITS, IF NECESSARY.¿ COMPLICATIONS: ¿THE PRINCIPAL COMPLICATIONS ASSOCIATED WITH CEREBROSPINAL FLUID SHUNTING INTO THE PERITONEUM ARE SHUNT OBSTRUCTION, FUNCTIONAL FAILURE OF THE SHUNT SYSTEM, INFECTION OR INTRACRANIAL HYPOTENSION. LOSS OF SHUNT PATENCY MAY RESULT FROM OBSTRUCTION OF THE PERITONEAL CATHETER BY PARTICULATE MATTER, THE OMENTUM OR COILED LOOPS OF BOWEL. LOSS OF VALVE AND/OR RESERVOIR PATENCY MAY RESULT FROM OBSTRUCTION OF THE FLUID PATHWAY BY PARTICULATE MATTER SUCH AS BLOOD CLOTS OR OTHER BIOLOGICAL ACCUMULATIONS.¿ THE COMPLAINT COULD NOT BE CONFIRMED SINCE FAILURE ANALYSIS DEMONSTRATED THAT THE CATHETER WAS NOT OBSTRUCTED AND WATER FLOWED THROUGH IT WITHOUT RESISTANCE. DOCUMENTATION REVIEW SHOWED THAT THERE WERE NO ANOMALIES DURING MANUFACTURING/PACKAGING PROCESSES THAT COULD BE RELATED TO THE REPORTED FAILURE. THE CATHETER WAS IN PLACE FOR ABOUT FOUR (4) MONTHS AND THUS THE MOST PROBABLE CAUSE FOR THE ¿CSF STOPPED FLOWING¿ MUST BE RELATED TO ONE OR MORE OF THE DIFFERENT COMPLICATIONS DISCUSSED IN THE IFU WHICH MAY CAUSE OBSTRUCTION OF PERITONEAL CATHETER WHEN ALREADY IMPLANTED.

    Description of Event or Problem · 1

    CEREBROSPINAL FLUID STOPPED FLOWING AND THAT CAUSED RE-OPERATION. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER (B)(6) 2016. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330976 REFLUX CONTROL PERITONEAL CATHETER, 120CM N/A JXG INTEGRA NEUROSCIENCES PR 1160354

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention