MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM WITH SA 10 AND SPRUNG RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FV425T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav shuntsystem (part # fv425t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the valve was believed to be not adjustable.Reportedly, the pressure was adjusted on (b)(6) 2021.However, a follow-up attempt to adjust the pressure on (b)(6) 2022 was not successful.The complaint device has not yet been returned to the manufacturer for evaluation.No further information available.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deformation of the housing.Measurement of surface of the housing: derformation detected: yes - measured value: 0,057 mm [tolerance (0 ± 0.02mm)] too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the test showed that the progav shunt system is permeable.During the test, particles leaked from the shunt system.Computer control test: the computer controlled test showed the opening pressure of the progav, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0,73 cmh2o.This is not within the specified tolerance of 10 cmh2o ± 3 cmh2o.An applied pressure of 10 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 10 cmh2o ± 3 cmh2o.Additional testing confirms the first test results.According to our results, we can detect a presence of an accelerated outflow in the progav.Additionally, the paedishuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 10 cmh2o in the vertical position, a pressure of 10 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the paedishuntassistant had a pressure of 6,48 cmh2o.This is not within the specified tolerance of 10 cmh2o +4/-2 cmh2o.Additional testing confirms the first test results.According to our results, we can detect a presence of an accelerated outflow in the paedishuntassistant.Adjustability test: the progav was found to be non-adjustable within the specified range.The paedishuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.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 7.5, an investigation of the braking force was not possible.Internal inspection of product: after dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we have determined that there was an accelerated outflow, non-adjustability and a deformation of the housing in the shunt system at the time of our investigation.Detected deposits were the cause of the mentioned malfunction.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further actions are required.

• Brand Name: PROGAV SYSTEM WITH SA 10 AND SPRUNG RES.
• Common Device Name: 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: 14140977
• Report Number: 3004721439-2022-00106
• Device Sequence Number: 20391173
• Product Code: JXG
• UDI-Device Identifier: 04041906132224
• UDI-Public: 4041906132224
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 07/07/2025
• Device Model Number: FV425T
• Device Catalogue Number: FV425T
• Device Lot Number: 20048983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown