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

Model Number FX410T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Height: 84 cm.Investigation.Visual inspection: no significant deformations or damage of the valve was detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: in order to verify the presumed "non-adjustability", we tried to adjust the valve to all pressure levels, both upwards and downwards.The adjustment test has shown that the progav 2.0 is adjustable.Braking force and brake function test: the investigation of the braking force of the progav 2.0 valve showed the brake functions fully operational and the braking force is within the given tolerances.Results: first, we performed a visual inspection of the valve.No significant deformations or damages of the valve were detected during the visual inspection.Further, we tested the permeability of the progav 2.0.The test has shown that the valve was permeable.The suspected occlusion cannot be confirmed.In order to verify the presumed "non-adjustability", we tried to adjust the valve to all pressure levels, both upwards and downwards.The test has shown that the valve is adjustable to all pressure ranges.We then measured the braking function and the braking force.With the help of the brake force meter, the function of the brake on the progav 2.0 could be proven without any problems.The braking force of 550 g was also within the specification.In order to verify whether the valve examined here possibly was influenced by the known risks of hydrocephalus therapy, such as natural substances in the cerebrospinal fluid (protein, blood or tissue particles), we finally opened the valve.Based on our investigation, we are unable to substantiate the claim of occlusion or non-adjustability.The progav 2.0 operates within the specified tolerances and is adjustable to all settings as specified.However, we suspect that the deposits found inside the valve could have temporarily impaired the function.Deposits due to natural substances in the cerebrospinal fluid, e.G.Protein, blood or tissue particles are among the known and inevitable risks of hydrocephalic therapy.Nevertheless, we can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).Further actions: no further actions are required in our point of view.

Event Description

It was reported that a valve is not able to be adjusted.The reporter indicated that a 7 month 7 day post-operative valve has a blockage and adjustment is not possible.The device was explanted.Additional event details were not provided.

• Brand Name: PROGAV 2.0 VALVE
• 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: 9728509
• MDR Text Key: 188412172
• Report Number: 3004721439-2020-00043
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141687
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20041661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2019
• 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: 20 MO
• Patient Weight: 10