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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx420t) was believed to have a blockage.The patient underwent a revision procedure.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 150 cm.Weight: (b)(6).Gender: female.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® 2.0 shunt system was manufactured by a qualified employee on august 2020.Deviations during assembly did not occur.The product was finally tested as article fx420t and released for packaging and sterilization and was sterilized by miethke.All tested parameters were assessed according to specifications.Visual inspection: the following observations were made during the visual inspection: - no anomalies were detected.Permeability test: the test showed that the progav® 2.0 shunt system is 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 -2,13 cmh2o.This is not within the specified tolerance of 4 cmh2o ± 3 cmh2o.An applied pressure of 4 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 4 cmh2o ± 3 cmh2o.Additionally, the shuntassistant® was tested according to standard procedure in the vertical and horizontal position of the valve.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 20 cmh2o -2/+4 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 20, 27 cmh2o.This is within the specified tolerance of 20 cmh2o -2/+4 cmh2o.The test, performed in the horizontal position of the valve at a reference flow of 20 ml/h showed that the shuntassistant® with a result of 1,38 cmh2o is operating within the specified tolerance (0/+4 cmh2o).Adjustability test: the progav® 2.0 and the 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 valves was within the specified tolerance and the brake function operated as expected.Internal inspection of product: after dismantling of the valves, no deposits were found inside the progav® 2.0 and the shuntassistant®.Results: based on our investigation results, we can identify a accelerated outflow in the shunt system.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction.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.
Event or Problem Description
Investigation is completed.

• 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
• MDR Report Key: 12100297
• Report Number: 3004721439-2021-00177
• Device Sequence Number: 4259149
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2021

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: 08/10/2025
• Device Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20049257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/12/2021
• 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: 79 YR
• Patient Weight: 40