MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG OTSDAMPROGAV 2.0 SYS SA2.0 25 & CONTROL RES.; HYDROCHEPHALUS MANAGEMENT

Model Number	FX552T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: no significant deformation or damage to the valves was found during the inspection, but deposits were found inside the supplied control reservoir.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in the horizontal position.The results show that the valve is not operating within the acceptable tolerance in the horizontal position.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, deposits were found inside.To make the proteins / deposits in the valve more visible, they were colored using a staining solution.Result: in advance, we would like to point out that the product sent in was not submerged in liquid at the time of delivery.The testing of dry valves is only of limited value.The product properties can be influenced by dry residues of cerebrospinal fluid or blood.Despite this, we have examined the valve.Based on our investigation results, we can determine a slower outflow in the valve.The determined deposits can be named as the cause for the slower outflow.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in 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 gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 (part # fx552t) was implanted during a procedure performed on (b)(6) 2019.According to the complainant, the valve was believed to be operating in under-drainage.The patient underwent a revision procedure performed on (b)(6) 2023.The complaint device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 60 years.Weight: 86 kilograms (kg).Height: 172 centimeters (cm).Gender: male.

• Brand Name: OTSDAMPROGAV 2.0 SYS SA2.0 25 & CONTROL RES.
• Common Device Name: HYDROCHEPHALUS 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: 16553432
• Report Number: 3004721439-2023-00055
• Device Sequence Number: 2970069
• Product Code: JXG
• UDI-Device Identifier: 04041906503178
• UDI-Public: 4041906503178
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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: 07/04/2024
• Device Model Number: FX552T
• Device Catalogue Number: FX552T
• Device Lot Number: 20042872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2019
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 86 KG