MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 25 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number FX649T

Device Problem Increase in Pressure (1491)

Patient Problem Hydrocephalus (3272)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

Visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are 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 under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Both valves are operating within acceptable tolerances.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.Both valves were shown to be permeable and their opening pressures were 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 valves.There were no visible deposits observed inside the valves.Based on our investigation, we are unable to substantiate the claim of under-drainage and blockage.At the time of our investigation, the valves were operating within the specified tolerances.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.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 progav® 2.0 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).

Event Description

It was reported that there was a problem with a progav 2.0 shunt system.After 2 month and 27 days the reporter suspected a underdrainage and a blockage.Patient information: age: (b)(6) years.Weight: (b)(6).Height: 184 cm.Gender: unknown.

• Brand Name: PROGAV 2.0 W/SA2.0 25 & DISTAL CATHETER
• Type of Device: HYDROCEPHALUS 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: 10337957
• MDR Text Key: 208204857
• Report Number: 3004721439-2020-00158
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190174
• 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: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX649T
• Device Catalogue Number: FX649T
• Device Lot Number: 20045262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 110