MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX426T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation has not yet begun.Additional informations / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a sprung reservoir to the progav 2.0 shuntsystem.According to the complainant,when shunt was assembled on the sterile table the physician assistant was unable to prime the shunt using the control reservoir.The patient was under anesthesia, there was no delay in surgery, and the surgeon had a back-up shunt to use instead.Additional information has been requested but not yet received as of this report.Additional patient information is not available.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: - no abnormalities are detected permeability test: the test showed that the all separated components of the progav 2.0 shunt system are permeable.The sprungreservoir could be filled with liquid and also drains it again.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, we have dismantled the shunt system.Due to the fact that the products were not implanted, we have only separated but not dismantled the valves.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in in a dry condition is only of a limited value.The product performance can be affected by dry residues of cerebrospinal fluid, blood or test liquid.In spite of this we have tested the shunt system to the best of our abilities.Based on our investigations, we were not able to confirm the claim of "blockage".At the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.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.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11517407
• Report Number: 3004721439-2021-00050
• Device Sequence Number: 19790711
• Product Code: JXG
• UDI-Device Identifier: 04041906136963
• UDI-Public: 4041906136963
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/21/2021

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: 06/10/2024
• Device Model Number: FX426T
• Device Catalogue Number: FX426T
• Device Lot Number: 20043190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/21/2021
• 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