MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDRCEPHALUS MANAGEMENT

Model Number FX413T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

Investigation result: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection. Permeability test: a permeability test has indicated that the progav 2. 0 valve has a blockage and that the shunt assistant is permeable. Adjustment test: the progav 2. 0 valve was tested and is not adjustable throughout the normal range. Braking force and brake function test: the brake functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve. Computer controlled test: to investigate the claim of blockage of the valves, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow. Because the progav 2. 0 valve is not permeable, a computer controlled test was not possible. The shunt assistant operates within the accepted tolerance. Results: first we performed a visual inspection of the progav 2. 0 shunt system. No significant deformations or damage of the valves were detected during the visual inspection. Next we tested the permeability and opening pressure of the valves. The progav 2. 0 valve was not permeable, therefore the claim of over/under-drainage could not be further investigated. The shunt assistant 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 was not adjustable to all settings. The brake functionality was fully operational, however due to the inability of the valve to hold a set pressure, it was not possible to measure the brake force. Finally, we have dismantled the valves. Inside both valves we have found significantly build-up of substances (likely protein). Based on our investigations, we confirm the presence of occlusion in the system at the time of investigation. This is likely due to the deposits observed inside the valves. As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants. 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). From our point of view, no further regulatory actions are required.

Event Description

It was reported that there was a problem with a progav 2. 0 shuntsystem. The shuntsystem is clogged. More information about the patient are not available. The patient was a premature newborn, (b)(6) week of pregnancy.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 20
• Type of Device: HYDRCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10464840
• MDR Text Key: 204700784
• Report Number: 3004721439-2020-00171
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FX413T
• Device Catalogue Number: FX413T
• Device Lot Number: 20038474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/28/2020 Patient Sequence Number: 1