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	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/02/2023
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 (#fv434-t) was implanted during a procedure.According to the complainant, the shunt system caused a blockage.The patient underwent a revision procedure.No further information available at this time.
Event or Problem Description
The returned product for investigation is a progav 2.0 shuntsystem (#fx352t).The follow up was updated completely.Patient data: age: 66 years.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, no significant deformations or damage of the shunt system was determined.Permeability test: a permeability test has shown that the shunt system is permeable.Computer controlled test: to investigate the claim of blockage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical position.The results show that the valves are operating within the accepted tolerance in the both positions.Adjustment test: the progav valve was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational.The measurement of braking force is not applicable due to the determined non-adjustability of the valve.Internal inspection : after dismantling of the valves, deposits were found both valves.Results: based on our investigation results, we can determine a non-adjustability at the progav 2.0 valve.The determined visible deposits inside may have affected the function of the valve.Deposits caused by substances naturally present in the patient's bodies, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valves.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.

• 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: 17625340
• Report Number: 3004721439-2023-00253
• Device Sequence Number: 7386379
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 12/31/2020
• Device Model Number: FX352T
• Device Catalogue Number: FX352T
• Device Lot Number: 20029356
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2016
• 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: 66 YR
• Patient Sex: Unknown