MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX421T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation results: visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is 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 is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The first measurement showed that, contrary to the assumed underdrainage, the valve shows a slight tendency to over drain.Nevertheless, the valve is in the reference flow range of 5 ml/h in the horizontal body position with a value of 3.86 cmh20 within the tolerance (5 cmh20 ± 2 cmh20).Result: first, we performed a visual inspection of the progav® 2.0.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve operates as expected and met all specifications.To ensure whether the shunt assistant could have led to the suspected underdrainage, we also examined the valve.We also performed a permeability test on the shunt assistant.The examination showed that the valve is not permeable.For this reason, a measurement on our test bench was not applicable.Finally, we have dismantled the valves.
Event or Problem Description
It was reported that a progav system (fx421t)was implanted during a procedure performed in (b)(6) 2016.According to the complainant, the progav system was believed to be blocking and underdrainage.The patient underwent a revision procedure on (b)(6) 2016.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient information: age: (b)(6).

• Brand Name: PROGAV 2.0 WITH SA25 AND DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12466572
• Report Number: 3004721439-2021-00642
• Device Sequence Number: 17092235
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• 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
• Report Date (Section B): 09/14/2021

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 Model Number: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20029212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 09/14/2021
• 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: 6 MO