MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 20 & PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX590T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: -particles in the delivery liquid, -signs of mold on the product.Permeability test: the test showed that the progav 2.0 shunt system with controlreservoir is permeable.Additionally the peritoneal catheter is permeable, too.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 11.51 cmh2o.This is within the specified tolerance of 14 cmh2o ± 3 cmh2o.Additionally, the shuntassistant 2.0 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 2.0 had a pressure of 17.68 cmh2o.This is slightly outside the specified tolerance of 20 cmh2o +4/-2 cmh2o.According to our results, we can detect a presence of a slightly accelerated outflow of the shuntassistant 2.0.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.The shuntassistant 2.0 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, we have dismantled the shunt system.After dismantling of the valves, no deposits were found in both valves.Results: in advance, we would like to point out that a permeability test with a syringe has already been performed after the revision on your part.Based on our investigation results, we can identify an accelerated outflow in the shuntassistant 2.0.At the time of the investigation, it was not clear to us how the mentioned functional impairment occurred.A blockage of the shunt system could not be detected.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.Even small amounts of non-visible deposits/proteins might compromise 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.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (part # fx590t) was to be implanted during a procedure performed on (b)(6) 2021.According to the complainant, during pre-implantation testing, a slow shunt flow was noted.The surgery was delayed approximately 25 minutes.A backup product was implanted and the operation was completed safely.The patient is doing well.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Age: (b)(6).Height: (b)(6) centimeters (cm).Weight: (b)(6) kilograms (kg).Gender: female.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12484610
• Report Number: 3004721439-2021-00251
• Device Sequence Number: 14437248
• Product Code: JXG
• UDI-Device Identifier: 04041906503048
• UDI-Public: 4041906503048
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2026
• Device Model Number: FX590T
• Device Catalogue Number: FX590T
• Device Lot Number: 20053575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 49