MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W. PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX438T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Hydrocephalus (3272)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx438t) was implanted in (b)(6) 2020.According to the complainant, the shunt system was believed to be clogged.The patient underwent a revision procedure.The complaint device was returned for evaluation.No patient complications were reported as a result of the revision procedure on (b)(6) 2021.Patient informations: age y: (b)(6).Same patient/event: medwatch#3004721439-2021-00061.
Additional Manufacturer Narrative
Investigation: block a2, a4, d9 visual inspection: the following observations were made during the visual inspection: -some visible particles in the delivery liquid permeability test: the test showed that the progav 2.0 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 6.69 cmh2o.This is within the specified tolerance of 8 cmh2o ± 3 cmh2o.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, some deposits were found in the progav 2.0.Results: based on our investigation results, we cannot identify a "blockage", no deviations are detected.However, we assume that the significant deposits found within the valve may have temporarily 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.
Event or Problem Description
Additional infofmation: age: 15 months height: 58 cm weight: 5.3 kg.

• Brand Name: PROGAV 2.0 SYS PED.W. PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11589357
• Report Number: 3004721439-2021-00060
• Device Sequence Number: 4183031
• Product Code: JXG
• UDI-Device Identifier: 04041906137434
• UDI-Public: 4041906137434
• 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 Implanted Year: 2020
• 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): 05/26/2021

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: 10/03/2023
• Device Model Number: FX438T
• Device Catalogue Number: FX438T
• Device Lot Number: 20039641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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: 15 MO
• Patient Weight: 5