MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-19 for PROGAV 2.0 VALVE FX410T manufactured by Christoph Miethke Gmbh & Co. Kg.
[188561305]
Investigation: visual inspection: in the first step of our investigations, an optical control is carried out. It is checked whether any defects, deformations or other noticeable irregularities can be identified. Permeability test: to proof the penetrability of the valve we have carried out penetrability tests. These tests are carried out at a calculated hydrostatic high (open pressure of the valves + 30cmh2o) in horizontal direction of flow. Adjustment test: the adjustment test is used to ensure that the progav 2. 0 can be adjusted to all pressure levels. The tests are carried out with the standard progav 2. 0 checkmate and measurement tool. The valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o. Braking force and brake function test: to measure the braking force, we tested the progav 2. 0 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. Results: no significant deformations or damage of the valves were detected during the visual inspection. Next, we tested the permeability of valve. The progav 2. 0 was permeable and operating within specifications. Additionally, we tested the adjustability as well as the brake functionality and brake force of the progav 2. 0 valve. The valve operated as expected and met all specifications. Finally, we have dismantled the valve. Inside the valve, we have found visible slight build-up of substances (likely protein). Based on our investigation, we are unable to substantiate the claim of occlusion. At the time of our investigation, the valve was shown to be permeable. At the time of the investigation, we are not able to determine how the functional impairment mentioned above occurred in the past. However, we suspect that the significant deposits found inside the valve have led to the functional impairment in the past. We can exclude a defect at the time of release. The shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188561306]
It was reported that there is an issue with valve. The reporter indicated that a post-operative valve has a blockage. The device was explanted. Additional event details and patient information has not provided, however, have been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004721439-2020-00066 |
| MDR Report Key | 9856966 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOERG KNEBEL |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal | 14469 |
| Manufacturer G1 | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Street | 2 ULANENWEG |
| Manufacturer City | POTSDAM D, 14469 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 14469 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGAV 2.0 VALVE |
| Generic Name | HYDROCEPHALUS MANAGEMENT |
| Product Code | JXG |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-03-03 |
| Model Number | FX410T |
| Catalog Number | FX410T |
| Lot Number | 20042933 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHRISTOPH MIETHKE GMBH & CO. KG |
| Manufacturer Address | 2 ULANENWEG POTSDAM D, 14469 GM 14469 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |