MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.; HYDROCEPHALUS VALVES

Model Number FX434T

Device Problem Obstruction of Flow (2423)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "2m po overdrainage.Explanted.Delivered with the return kit inside an unknown liquid."over-drainage, valve raised to 20 cmh2o due to massive overdrainage.During intraoperative valve testing, the valve opens passively at <10 cmh2o water column pressure.All med watch submissions related to this report are: 3004721439-2018-00162 ( this report); 3004721439-2018-00163.

Manufacturer Narrative

All related events: 3004721439-2018-00162, 3004721439-2018-00163.Production and quality assurance data: the progav2.0 was certified by a qualified staff member in december 2017.No abnormalities occurred during assembly.The valve was released for packaging and sterilization and sterilized by company autoclave.The progav2.0 valve has the target pressure levels 0 to 20 cmws.The valve characteristics after closing the valve for 5 ml / h or 50 ml / h flow for the set compression level 0.10 and 20 cmh2o were fine.The valve has been finalized as item fx434t and approved for shipping.The valve characteristics correspond to the specification.The brake was adjusted according to the specification.The progav 2.0 has been preset to position 5 cmh2o.The tightness of the system has been tested and proven.All controlled characteristic values were within the required specification.Investigation: optical test in the first step of our investigations we have carried out a visual inspection.The optical investigation showed significant scratches, but none demonstrate deformation or similar damage.Penetration test: to check if the valve is clogged, we have one permeability test made.This test is at a hydrostatic pressure difference of approx.20 - 30 cmh2o in flow direction carried out.The test has shown that the valve is permeable.Adjustment test: we tried all the pressure steps in steps of 5 at the valve up and down to adjust.The investigation has revealed that the valve could be adjusted up and down in all pressure step ranges.Brake force and brake function test: to measure the brake release force, we checked the valve with a brake force meter.Housing must be exercised to release the rotor to the valve, through the magnet integrated in the device.The braking function could be proven positive.The measured values of braking power, however, were outside the expected specification.Our testing has shown that less force is necessary to release the rotor to adjust the valve.We have determined a reduced brake function.Test at the computer test bench: the valve is tested on the miethke test bench.It goes through the standard test for the horizontal position.Here, the liqourflow of 60 ml / h gradually reduced to 5 ml / h and increased again to 60 ml / h (in based on iso 7197).The resulting pressure is measured.Result: at the beginning of our investigations we have an optical at the valve test performed.There could be scratches, but no deformations or damage to the valve can be detected.In the further course, the progav2.0 was positive for permeability tested.As part of the adjustment test, it was possible to set the valve throughout the pressure step range.With the help of the brake force meter, the function of the brake could indeed be positively demonstrated, but the braking force was outside the specification.We have determined a reduced brake function.A fall or a blow to the head of the patient may compromise the integrity of the valve negatively.The cause of the reduced brake function was not determined to investigate the suspicion of overdrainage,the progav2.0 valve was subjected to a test bench measurement.The valve has gone through the standard test in the horizontal body position.At a set opening pressure of 5 cmh2o is a resulting pressure in lying body position of 5 cmh2o ± 2 cmh2o is to be expected.The measurement has shown that the valve is in reference flow range of 5 ml / h in the horizontal body position with a value of 4.04 cmh2o which is within the allowable tolerance (permissible tolerance 5 cmh2o ± 2 cmh2o).One of the known risks of hydrocephalus therapy is the functional hazard due to natural substances in the csf like protein, blood or tissue particles.To investigate if this is the case the implant considered here, we opened the valve.After opening the progav2.0 valve, only minimal deposits could be created inside the valve.On the basis of our investigation results, we do not confirm overdrainage.However, even small, not visible amounts of protein to be able to function temporarily influence valve.A defect of the valve at the time of delivery can be excluded.Based on our original documentation we can assure that the valve left christoph miethke gmbh & co.Kg within specification.No corrective action is required.

• Brand Name: PROGAV 2.0 SYS W/SA20 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7824479
• MDR Text Key: 118523376
• Report Number: 3004721439-2018-00162
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2022
• Device Model Number: FX434T
• Device Catalogue Number: FX434T
• Device Lot Number: 20036117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Distributor Facility Aware Date: 08/23/2018
• Device Age: 8 MO
• Date Manufacturer Received: 10/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 90