MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV427T
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation results: visual inspection: no deviations are detected.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 measured value of -0.014 mm lies within the given tolerance (0 ± 0.02mm).Permeability test: the test showed that the progav is permeable.Computer controlled test: the computer controlled test has shown the opening pressure of the progav, at a reference flow rate of 20 ml/hr in a horizontal position, to be 1.73 cmh2o.This is within the specified tolerance of 0 cmh2o ± 3 cmh2o.Adjustability test: the progav was found to be not adjustable to specifications.Braking force and brake function test: the braking force test indicates that the brake function of the progav is present.Due to the non-adjustability of the valve, as detailed in section.Adjustability test of the braking force was not possible.After dismantling of the valve, clearly deposits were found in progav.Results: based on our investigation, we are not able to substantiate the claim of "under-drainage".We were able to detect during the investigation that the valve was not adjustable.However, we assume that the significant deposits found within the valve may have temporarily caused the functional impairment.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.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).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav system and a prosa shunt (reference associated mdr id 3004721439-2020-00153) were explanted from a patient on (b)(6) 2020 due to suspected underdrainage.

• Brand Name: PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam 14469 ; GM 14469
• MDR Report Key: 10373892
• Report Number: 3004721439-2020-00154
• Device Sequence Number: 3447075
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20009889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention