MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE; HYDRCEPHALUS MANAGEMENT

Model Number FV701T

Device Problem Mechanical Problem (1384)

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

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Exact height: 4´8 feet.Exact weight: 81 pounds.Investigation is completed.Visual inspection: we have checked for possible damages, deformations of the housing or other abnormalities.- no abnormalities are observed.Measurement of surface of the housing: to verify whether the deformation had an effect on the plane-parallelism of the housing surface, this was measured using a dial gauge.The measurement of the plane parallelism confirmed the non- deformation of the visual inspection.The measured value of -0.002 mm lies within the given tolerance [0 ± 0.02mm].Permeability test: this test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the prosa is permeable.Adjustability test: we have investigated whether the prosa can be successfully set to each specified pressure setting.The prosa was found to be adjustable to all pressure settings.Braking force and brake function test: a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves.His apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus.The braking force of the prosa was within the specified tolerance and the brake function operated as expected.After dismantling of the valve, slightly deposits were found in prosa.Based on our investigation, we are not able to substantiate the claim of "programming issues." at the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of non- visible deposits might compromise the integrity of the valve.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 (b)(4).From our point of view, no further regualatory actions are required.

Event Description

It was reported that the was an issue with a prosa and progav 2.0."the surgeon attempted to move the prosa setting from 12 to 14.When she adjusted valve to 0.Attempted to move back to 12- 14 and valve was stuck at 0.She also believes there have been inconstant readings on progav 2.0." height: 4´8 feet.Implantation: 2018.Removal: (b)(6) 2020."associated medwatches: 3004721439-2020-00110 , mdr # - same patient.".

• Brand Name: PROSA VALVE
• 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: 10205892
• MDR Text Key: 196820456
• Report Number: 3004721439-2020-00123
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20022636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2014
• 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: 12 YR
• Patient Weight: 37