MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 25 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV442T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: scratches on the outer housing of the valve were observed through the visual inspection.The progav valve housing was subsequently measured and indicated the presence of a deformation.The housing deformation measured at -0.0515 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the progav 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 operates as expected.However, the breaking force required was not within the given specifications.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 results show that the valve operates within the accepted tolerance in the horizontal position.Result: first, we performed a visual inspection of the progav.Scratches on the outer housing of the progav valve was observed through the visual inspection.A deformation was detected through a measurement of the plan parallelity.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The brake function did not operate as expected, but all other specifications were met.Finally, we have dismantled the valve.Inside the valve we have found a slight build-up of substances (likely protein).Based on our investigation, we can detect a slight deformation and a deviation in the brake force measurement.We are unable to substantiate the clinical claim of under-drainage.At the time of our investigation, the opening pressure of the valve was within the specified tolerances.For the deviation in the brake force measurement is probably the deformation responsible.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.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 (part # fv442t) was implanted during a procedure performed in (b)(6) or (b)(6).According to the complainant, the shunt system was believed to be operating in underdrianage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) height: (b)(6) ) weight: (b)(6) gender: female.

• Brand Name: PROGAV SYS PED.W/SA 25 A.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12149824
• Report Number: 3004721439-2021-00191
• Device Sequence Number: 14656819
• Product Code: JXG
• UDI-Device Identifier: 04041906132552
• UDI-Public: 4041906132552
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 11/13/2016
• Device Model Number: FV442T
• Device Catalogue Number: FV442T
• Device Lot Number: 20015274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/12/2021
• 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: 28 YR
• Patient Weight: 53