MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT

Model Number FX414T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Patient Problem/Medical Problem (2688); Hydrocephalus (3272)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Height: 150cm. Investigation: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection. Permeability test: a permeability test has shown that the progav 2. 0 valve is permeable. Adjustment test: the progav 2. 0 valve was tested and is adjustable to all specified pressures. Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances. Computer controlled test: to investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow. The progav 2. 0 valve is not operating within acceptable tolerances. Result: first, we performed a visual inspection of the progav 2. 0 valve. No significant deformations or damage of the valve were detected during the visual inspection. Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force. The progav 2. 0 valve operates as expected and met all specifications. The opening pressure of the progav 2. 0 was significantly lower than expected, indicating a tendency towards over-drainage. Finally, we have dismantled the valve. Inside the valve, we have found a build-up of substances (likely protein). Based on our investigation, we confirm that the progav 2. 0 valve was operating in an over-drainage state at the time of our investigation. This is likely due to the deposits observed inside the valves. As described in our 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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co. Kg.

Event Description

It was reported there was a valve defect. The reporter indicated that a post operative valve over and /under drains. The device required explantation. Additional details of the event have not been provided.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9392011
• MDR Text Key: 168783570
• Report Number: 3004721439-2019-00280
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FX414T
• Device Catalogue Number: FX414T
• Device Lot Number: 20040622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 11/29/2019 Patient Sequence Number: 1