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

Model Number	FV425T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a progav shunt system (part # fv425t) was implanted.According to the complainant, the shunt system was believed operated in underdrainage and the progav was difficult to adjust.The patient underwent a revision procedure.The complaint device was not returned for evaluation.No patient complications were reported as a result of the revision procedure on (b)(6) 2021.Patient informations: (b)(6), height cm: 160, (b)(6).Gender: female.
Additional Manufacturer Narrative
Corrected information: - d4 - serial #, lot #,h4 investigation: visual inspection: the following observations were made during the visual inspection: - visible deposits in the sprungreservoir and on the ventricular catheter 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.Deformation detected: yes - measured value: - 0.046mm [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.The test showed that the sprung reservoir, ventricular catheter and the peritoneal catheter are permeable.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 3.87 cmh2o.This is within the specified tolerance of 6 cmh2o ± 3 cmh2o.Additionally, the shuntassistant 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 shuntassistant had a pressure of 8.49 cmh2o.This is within the specified tolerance of 20 cmh2o +4/-2 cmh2o.Adjustability test: the progav was found to be non- adjustable within specified range.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", an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in both valves.Results: based on our investigation results, we can identify adjustment difficulties of the shunt system.We are assuming that the deposits detected within the valve have 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.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.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 regulatory actions are required.

• Brand Name: PROGAV SYSTEM W.SA 10 A.SPRUNG RES.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11589657
• Report Number: 3004721439-2021-00056
• Device Sequence Number: 4183030
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 06/30/2025
• Device Model Number: FV425T
• Device Catalogue Number: FV425T
• Device Lot Number: 20048466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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
• Patient Age: 62 YR
• Patient Weight: 58