MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR; HYDROCEPHALUS VALVES

Model Number FV425T

Device Problem Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient information unknown: weight and height.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "the surgeon discovered water was leaking from the fv425t.The pressure was 20, but the flow rate was too fast, it was two drops per second during surgery.The normal flow rate is one drop per six seconds.The surgeon replaced the fv425t in the patient.The flow rate was normal, one drop per six seconds." it was reported that the patient was fine after the surgery, the surgery was a success.

Manufacturer Narrative

The shunt system was received submerged in an unidentified liquid in a plastic container.No significant deformation or damage of the valve were detected during the optical inspection.To proof the penetrability of the valves we have carried out penetrability tests.These tests are carried out at a hydrostatic pressure of approximately 20-30 cmh20 in the direction of flow.The test results show that both valves are permeable.Our adjustment tests are carried out with the standard progav check mate and measurement tool.The valve is adjusted from 0 to 20cmh2o and down again in increments of 5cmh2o.The valve was adjustable to all settings.To measure the baking force, we tested the progav valve with a braking force apparatus.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force apparatus.The investigation of the braking force showed the brake function is fully operational and the braking force is within the given tolerances.The test is performed with miethke computer controlled testing apparatus.The valve are tested by simulating a cerebrospinal fluid flow at rates between 60 ml/h down to 5ml/h and up again to 60ml/h with the valves in vertical position and horizontal position.Distilled water is used as the test-liquid.The opening pressure is expected to measure at the reference flow rate +- 2 cmh2o in the horizontal position and 0 +- 4 cmh2o in the vertical position.The opening pressure in the horizontal position at a reference flow level of 5ml/h was measured at 3.97 cmh2o.The valve operates within the acceptance tolerance.The opening pressure in the vertical position at a reference flow level of 5 ml/h was measured at 0.18cmh20.The valve operates within the accepted tolerance.We performed an optical inspection of the progav shunt system.No deformation or damage of the valve were detected during the visual inspection.Next we tested the permeability of both valves.The test results show that both valves are permeable.To ensure that the progav valve is adjustable we tried to adjust the valve from 0 cm h2o to 20cmh2o and down again in increments of 5 cmh2o.The valve was adjustable to all settings.Next we tested the braking force and brake functionality.The results show that the brake function is fully operational and the braking force is within the given tolerances.Finally, we carried out a computer controlled simulated flow test.The measured opening pressure in both orientations was within the accepted tolerance.In order to verify whether the valves were compromised by the known risks of hydrocephalus therapy, e.G.By a buildup of natural substances (protein blood or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.Inside the paedisa we have found a slight build up substance (likely protein), which may have caused the suspected malfunction in the past.Based on our investigation, we are unable to substantiate the claim of over drainage.The progav shunt system operates within all specified tolerances.We would like to point out that even small non-visible deposits could temporally lead to an impairment of the shunt system.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspections.No capa is necessary.

• Brand Name: PROGAV SYSTEM W/SA 10 A.SPRUNG RESERVOIR
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157848
• MDR Text Key: 130504024
• Report Number: 3004721439-2018-00299
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2023
• Device Model Number: FV425T
• Device Catalogue Number: FV425T
• Device Lot Number: 20037601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Distributor Facility Aware Date: 01/15/2019
• Device Age: 6 MO
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR