MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0; HYDROCEPHALUS MANAGEMENT

Model Number FX424T

Device Problem Mechanical Problem (1384)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

In (b)(6) 2015, the product was used for surgery for postmeningitis hydrocephalus in a (b)(6) newborn.Pressure set inside the valve: first time : 7 cm h2o.1 week later : 9 cm h2o.(b)(6) 2016 : 7 cm h2o.(b)(6) 2016 : 5 cm h2o.The patient was discharged because of good progress.(b)(6) 2020 : emergency hospitalization due to sudden changes in condition (headache and vomiting).Shunt failure was not seen on ct images.There was a sign of slit ventricle syndrome, so the setting pressure was changed from 5 cm h2o to 10 cm h2o.(check the changes on the computer, no x-ray).Since there was no improvement after that, a surgeon tried to change the pressure to 15cm h2o on (b)(6), but he could not change the pressure after trying to change it several times.Certas was performed on (b)(6).At last, the patient's conditions improved.After removing the valve, the surgeon tried to change the pressure, but could not confirm the change on the compass.No infection.This is the same patient from notification mdr #- 3004721439-2020-00163 and 3004721439-2020-00161.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: scratches on the outer housing but no deformations.Deposits on the periphere catheter.Permeability test: the test showed that the progav 2.0 is permeable.Computer control test: the computer controlled test has shown the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/hr in a horizontal position, to be 1.54 cmh2o.This is not within the specified tolerance of 5 cmh2o ± 3 cmh2o.An applied pressure of 5 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 5 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of an overdrainage.Adjustability test: the progav 2.0 was found to be non-adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve, an investigation of the braking force was not possible.Internal inspection of product: after dismantling of the valve, clearly deposits were found in progav 2.0.Results: based on our investigation, we are able to substantiate the claim of "over-drainage".We are assuming that the significantly visible deposits within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

Event Description

This is the same patient to mdr #3004721439-2020-00163 and 3004721439-2020-00161.

• Brand Name: PROGAV 2.0
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10404833
• MDR Text Key: 207334994
• Report Number: 3004721439-2020-00162
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2020
• Device Model Number: FX424T
• Device Catalogue Number: FX424T
• Device Lot Number: 20027905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR