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

Model Number	FX417T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Head Injury (1879); Hemorrhage/Blood Loss/Bleeding (1888); Hydrocephalus (3272)
Date of Event	04/09/2021
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 there was an issue with fv046t + fx417t shunt system.According to the complainant, the valve was believed to be operating with blockage.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient information: (b)(6) years.Explantation: (b)(6) 2021.The same event: medwatch#3004721439-2021-00133.
Additional Manufacturer Narrative
The same event: medwatch#3004721439-2021-00133.Investigation: visual inspection: no abnormalities were detected during the visual inspection.Permeability test: the permeability test showed that the progav 2.0 is permeable.The peritoneal catheter is not permeable.Computer control test: according to our results, we can confirm the presence of an accelerated outflow in the progav 2.0.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.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: after dismantling of the valve, clearly deposits were found in progav 2.0.Results: based on our investigation results, we can identify an accelerated outflow in the progav 2.0 and a blockage of the peritoneal catheter.We are assuming that the deposits detected have caused the functional impairment.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.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The valve 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 WITH DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11849821
• Report Number: 3004721439-2021-00134
• Device Sequence Number: 17091951
• Product Code: JXG
• UDI-Device Identifier: 04041906136598
• UDI-Public: 4041906136598
• 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): 06/22/2021

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: 07/02/2025
• Device Model Number: FX417T
• Device Catalogue Number: FX417T
• Device Lot Number: 20048666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/22/2021
• 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: 59 YR