MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 MIT SA25 U.DISTALEM KATHETER; HYDROCEHPHALUS MANAGEMENT

Model Number	FX421T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still pending.When additional informations are provided and the investigation is completed, a follow up will be provided in a supplemental report.
Event or Problem Description
It was reported that there was a problem with a progav 2.0 shuntsystem.The surgeon suspected an overdrainage.Patient informations: age: (b)(6).Height: 170 cm.Weight: (b)(6).Gender: female.Implantation: (b)(6) 2015.Removal: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation: visual inspection: dry bloody deposits and small deposits in the inlet spout are visible, but no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that both valves are permeable.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the specified tolerances.Computer controlled test: to investigate the clinical claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The progav 2.0 valve operates within the accepted tolerances in the horizontal position.The shunt assistant operates not within the accepted tolerance in the vertical position.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 or blood.In spite of this we have tested the valve to the best of our abilities.First, we performed a visual inspection of the progav 2.0 shunt system.No significant deformations or damage of the valves were detected during the visual inspection.Only deposits in the inlet spout are detected.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The opening pressure of the shuntassistant was out of tolerance, but all other specifications were met.The opening pressure of the shuntassistant was significantly lower than expected, shows an increased flow of liquid.Finally, we have dismantled the valves.Inside both valves, we have found build-up of substances (likely protein).Based on our investigation, we confirm that the shuntassistant shows an increased flow of liquid at the time of our investigation.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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.No further regulatory actions are required from our point of view.
Event or Problem Description
Additional information, the investigation is completed.

• Brand Name: PROGAV 2.0 MIT SA25 U.DISTALEM KATHETER
• Common Device Name: HYDROCEHPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11164559
• Report Number: 3004721439-2020-00273
• Device Sequence Number: 17073057
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• 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): 01/18/2021

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: No Information
• Device Model Number: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20027435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/03/2021
• 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: 73 YR
• Patient Weight: 60