MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 A.DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deposits inside the catheter, the ventricular catheter and in the reservoir permeability test: the test showed that the progav 2.0 shunt system is permeable.Therefore, the shunt system was separated from the ventricular catheter and individually tested for permeability.The progav 2.0 shunt system and the ventricular catheter are permeable.The single distal catheter, however, is not 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 11.98 cmh2o.This is within the specified tolerance of 14 cmh2o ± 3 cmh2o.An applied pressure of 14 cmh2o, with the device in the vertical position is expected to have a resultant pressure of 14 cmh2o ± 3 cmh2o.Additionally, the shuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 20 cmh2o +4/-2 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 19,21 cmh2o.This is within the specified tolerance of 20 cmh2o +4/-2 cmh2o.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 valves were 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.After dismantling of the valves, significant deposits were found inside the progav 2.0 and the shuntassistant.Results: based on our investigation results, we can identify a blockage in the distal catheter valve.No further functional deviation was detected in the shunt system during the examination.We are assuming that the deposits detected within the system 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 deposits/ proteins might compromise the integrity of the valve.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.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (# fx420t) was implanted during a procedure.According to the complainant, the shunt system was believed to be operated in overdrainage.The patient underwent a revision procedure.The event date was noted as (b)(6) 2021.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years, height: unknown, weight: unknown, gender: unknown.

• Brand Name: PROGAV 2.0 WITH SA20 A.DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12657731
• Report Number: 3004721439-2021-00284
• Device Sequence Number: 14572973
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2021

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: Health Professional
• Device Expiration Date: 03/22/2025
• Device Model Number: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20046884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/19/2021
• 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: 4 YR