MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX352T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation results will be be provided in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx352t) was implanted during a procedure.According to the complainant, the shunt system was believed to be not adjustable in the patients head.The patient underwent a revision procedure on (b)(6) 2021.The complainant device should be send to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 105 cm.Weight: (b)(6).Gender: male.
Additional Manufacturer Narrative
Manufacturing and quality control data the progav® 2.0 shunt system was manufactured by a qualified employee on may 2020.Deviations during assembly did not occur.The product was finally tested as article fx352t and released for packaging and sterilization and was sterilized by miethke.The progav® 2.0 has an adjustable pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5ml/h or 50 ml/h at set pressures of 0, 5, 10, 15and 20 cmh2o, and were found to meet specifications.The valve was pre-adjusted to 5 cmh2o in accordance with the specification.The shuntassistant® has a fixed pressure of 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5ml/h or 50m/h at a fixed pressure of 20 cmh2o, and were found to meet range of tolerances.All tested parameters were assessed according to specifications.Visual inspection the following observations were made during the visual inspection: - tissue residues on the returned product, but no visible obvious damages.Permeability test the test showed that the progav® 2.0 shunt system is permeable.Adjustability test the progav® 2.0 was found to be adjustable to all pressure settings.Braking force and brake function test the braking force of the progav® 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product after dismantling of the valve, some deposits were found in progav® 2.0.Results based on our investigation results, we cannot determine any adjustment difficulties of the valve.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.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.
Event or Problem Description
Investigation is done.

• Brand Name: PROGAV 2.0 WITH SA20 A.SPRUNG RESERVOIR
• 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: 12651614
• Report Number: 3004721439-2021-00282
• Device Sequence Number: 16494371
• Product Code: JXG
• UDI-Device Identifier: 04041906140014
• UDI-Public: 4041906140014
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2021

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: 05/26/2025
• Device Model Number: FX352T
• Device Catalogue Number: FX352T
• Device Lot Number: 20047974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2020
• 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 Age: 6 YR
• Patient Sex: Male
• Patient Weight: 50 KG