Catalog Number NL8500200 |
Device Problems
Partial Blockage (1065); Occlusion Within Device (1423)
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Patient Problems
Ventricle, Abnormality Of (2078); No Code Available (3191)
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Event Date 08/02/2017 |
Event Type
Injury
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Event Description
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On (b)(6) 2017, both the nl850-0200 and the certas plus valve of codman were removed from the patient and new ones were implanted because shunt blockages probably occurred.Contrast radiography wasn¿t done.It was reported that the date of incident was on (b)(6) 2017 (clarification request sent).Timeline of events: on (b)(6) 2017, the nl850-0200 was connected to a certas plus valve of codman and that was implanted to the patient.At that time the pressure was set at 2 of the valve performance setting which was equivalent to 50 mm h2o.On (b)(6) 2017, slit ventricle was observed and then the pressure was set at 4 of that which was equivalent to 110 mm h2o.On (b)(6) 2017, enlarged ventricles were observed and then the pressure was set at 3 of that which was equivalent to 80 mm h2o.On (b)(6) 2017, the pressure was set at 2 of that which was equivalent to 50 mm h2o.On (b)(6) 2017, slit ventricle was observed.The observation had been continued without change in pressure.On (b)(6) 2017, enlarged ventricles were observed under the pressure set at 2 of that which was equivalent to 50 mm h2o.On (b)(6) 2017, enlarged ventricles in progress were observed.On (b)(6) 2017, the pressure was set at 1 of that which was equivalent to 25 mm h2o.Additional information has been requested.
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Manufacturer Narrative
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Additional information received 10/06/2017: patient's underlying medical condition was reported as brain tumor.The patient recovered after the new shunt and valve were implanted.The reporter was only able to provide partial information.The sales representative will follow up with the physician.
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Manufacturer Narrative
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Investigation completed 08dec2017: one (1) bag was received containing one anti-siphon device (asd) attached to a catheter on the outlet side of the device.The inlet side of the device had a small piece of catheter still attached to it.Upon visual inspection, the asd did not appear to be damaged.The catheter placed on the outlet tube of the asd had a string tied on the distal part from the asd.The catheters were taken away from both ends of the asd to evaluate the device (only the connectors were left on the device).Since the knot seemed to strangulate the catheter, water was injected in the catheter.The water did not flow out the other end of the catheter.The string tied on the catheter was removed and then water flowed freely through the catheter.The catheter was filled with water and then connected to the inlet side of the asd.The catheter was raised above the asd and water flowed through the system.The condition where the asd was obstructed could not be duplicated.As per this evaluation the only component that was obstructed was the catheter due to the knot tied around it.It is unknown if the knot was placed in order to remove the device and avoid fluids spills or if it was there during use.No lot number was provided; therefore, no device history record (dhr) review was possible.Device identifier: (b)(4).No scar, ncr or capa related to the condition described was opened during the period of september 2015 to september 2017.Upon review of integra's complaint system from september 2015 to september 2017, there is only this complaint regarding blockage in anti-siphon devices.No defect was found on the unit evaluated (it was not obstructed); only the catheter was blocked due to the knot tied around it.It is unknown at what point was this knot placed on the catheter (during drainage process or in order to remove the device and avoid fluid spills).The complaint does not specifically say that the anti siphon device (asd) was obstructed as both the certas valve from codman and the asd were removed (any system component including catheter could have been blocked).Ifu instructs that the ¿fluid flow through the anti-siphon device should be verified immediately prior to implantation¿.Therefore, it is inferred that the device was properly working when implanted.Ifu also states that one of the principal complications in these type of procedures is shunt obstruction (which include catheter, valves and/or reservoirs) due to blood clots, fibrin, or brain fragments.No assignable cause related to asd manufacturing process was determined in this investigation.Additional information received 21dec2017: the date of aug 2, 2017 was misreported.The slit ventricle that occurred on (b)(6) 2017 was caused by wrong pressure setting and it didn't relate to defect of the catheter, so the correct reporting incident date is (b)(6) 2017 when the nl850-0200 and the certas plus valve were explanted.The patient's icp prior to implantation of the shunt nl850-0200 was unknown.Icp wasn't measured.The patient's ventricle on ct or mri image prior to implantation of the shunt nl850-0200 was enlarged.Icp were not measured.The patient did not have any symptoms during the time slit ventricle was observed on each of the dates reported and during the time enlarged ventricle was observed.The shunt and valve were flushed prior to implantation with saline solution.Ct/mri images were not permitted to be provided by the hospital.
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Search Alerts/Recalls
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