MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 10 A.BURRH.RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX425T
Medical Device Problem Code	Infusion or Flow Problem (2964)
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 become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a progav shuntsystem (part # fv446t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be clogged.The patient underwent a revision procedure and got a progav 2.0 shuntsystem.The complaint device will be return to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 2 years, 7 months.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: tissue residues on the product, deposits/ particles in the reservoir, and leak in the kink protection of the catheter.Permeability test: the test showed that all products are permeable.Computer control test: the computer controlled 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 2.60 cmh2o.This is not within the specified tolerance of 8 cmh2o ± 3 cmh2o.An applied pressure of 10 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 8 cmh2o ± 3 cmh2o.According to our results, we can detect a presence of an accelerated outflow.Additionally, the paedishuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 10 cmh2o in the vertical position, a pressure of 10 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the paedishuntassistant had a pressure of 9.27 cmh2o.This is within the specified tolerance of 10 cmh2o +4/-2 cmh2o.Adjustability test: it was checked whether the valve is fully adjustable within the full range of specified pressure settings (in increments of 5 cmh2o).The progav 2.0 was found to be adjustable to all pressure settings.The paedishuntassistant is a fixed pressure valve, therefore the adjustability test is inapplicable.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: 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 is/are finally opened with a special tool.After dismantling of the valves, deposits were found in both valves.For more detailed visibility, the proteins/deposits in both valves were colored by using a coloring solution.[coloring solution consisting of coomassi brilliant blue r mixed with 0.6% ethanol and distilled water].Results: based on our investigation results, we have determined that there was an accelerated outflow in the progav 2.0 valve at the time of our investigation.Detected deposits were the cause of the accelerated outflow.The named blockade could be not confirmed.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 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 SYS PED.W/SA 10 A.BURRH.RES.
• 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: 14632110
• Report Number: 3004721439-2022-00153
• Device Sequence Number: 11697073
• Product Code: JXG
• UDI-Device Identifier: 04041906136956
• UDI-Public: 4041906136956
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2022

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: 11/09/2025
• Device Model Number: FX425T
• Device Catalogue Number: FX425T
• Device Lot Number: 20050714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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: 31 MO
• Patient Sex: Unknown