MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER

Model Number	FX441T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information/investigation results became available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx441t) was implanted during a procedure performed on unknown.According to the complainant, the system was believed to be operated in adjustment problems.The patient underwent a revision procedure.The complaint device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: unknown.Weight: unknown.Height: unknown.Gender: unknown.
Event or Problem Description
Subsequently, it was reported that the complainant believed that the shunt system was blocked.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -particles in the delivery liquid; -deposits / residue tissues on the progav 2.0; -deposits in the pediatric prechamber.Permeability test: the test showed that all components are permeable.During the test, bloody liquid was flushed out of the shunt system.Computer control test: the computer control test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 9.80 cmh2o.This is within the specified tolerance of 10 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 20 cmh2o in the vertical position, a pressure of 20 +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 13.19 cmh2o.This is not within the specified tolerance of 20 +4/-2 cmh2o.According to our results, we can detect a presence of an accelerated outflow.Adjustability test: the progav 2.0 was found to be not adjustable.The shuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve, an investigation of the braking force is not applicable.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, the valves are finally opened with a special tool.After dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we have determined that there was a non- adjustability of the progav 2.0 valve and an accelerated outflow of the shuntassistant at the time of our investigation.The non- adjustability and the accelerated outflow in the shunt system were caused of the detected deposits.Existing deposits in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.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 2.0 SYS PED.W/SA20 A.PRECHAMBER
• Common Device Name: PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
• 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: 16694453
• Report Number: 3004721439-2023-00079
• Device Sequence Number: 7454636
• Product Code: JXG
• UDI-Device Identifier: 04041906137465
• UDI-Public: 4041906137465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2023

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: 03/16/2021
• Device Model Number: FX441T
• Device Catalogue Number: FX441T
• Device Lot Number: 20029724
• 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: 03/12/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2016
• 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: 6 YR
• Patient Sex: Female