MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/22/2022
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 2.0 shunt system (part # fx420t) was implanted during a procedure performed on (b)(6) 2022.According to the complainant, the shunt system was believed to be blocked.The patient underwent a revision procedure performed on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Same event as medwatch# 3004721439-2022-00319.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -discoloured areas at the catheter -blood and tissue residues permeability test: the test showed that the progav 2.0 shunt system is non-permeable.The ventricular catheter is permeable.To determine the location of the occlusion, the shunt system was dismantled and each element was tested individually for permeability.The test showed that the progav 2.0 is non-permeable, whereas the shuntassistant is permeable.Computer control test: due to the non-permeability of the progav 2.0, the computer-controlled test is not applicable.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 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant showed an opening pressure of 7,12 cmh2o.This is not within the specified tolerance of 20 cmh2o +4/-2 cmh2o.According to our results, we can detect an accelerated outflow.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.The shuntassistant 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 are finally opened with a special tool.After dismantling of the valves, bloody deposits were found in both valves.Additionally, a material residue was found in the inlet of the shuntassistant.Results: based on our investigation results, we confirm the blockage in the shunt system.Detected deposits could be named as the cause of the blockage.Endogenous substances in the csf can temporarily impair the function of the valve and is described as concomitant symptoms in hydrocephalus therapy.Concluding on the determined accelerated outflow at the computer test bench, we can prove that the determined material residue in the shuntassistant was not the cause for the blockage in the shunt system.From our point of view, no further regulatory actions are required.
Event or Problem Description
Same event as medwatch# 3004721439-2022-00319.

• Brand Name: PROGAV 2.0 WITH SA20 AND DISTAL CATHETER
• 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: 15654913
• Report Number: 3004721439-2022-00320
• Device Sequence Number: 2356745
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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 Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20057327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: 10 YR
• Patient Sex: Unknown