MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W. SA2.0 15 A.DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX647T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/26/2021
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 there was an issue with a progav 2.0 shuntsystem (fx647t).According to the complainant, the shuntsystem was believed to be clogged (under-drainage).The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision.Patient informations: age: (b)(6) years.Weight: (b)(6).Height: 154 cm.The patient has increased protein in the liquor.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® 2.0 shunt system was manufactured by a qualified employee in november 2015.Deviations during assembly did not occur.The system was sterilized by miethke and released for shipment after final inspection.For the purposes of this investigation, the progav® 2.0 shunt system is comprised of a progav® 2.0 adjustable pressure valve and a shuntassistant® fixed pressure valve.The shunt system was inspected as article fx647t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection: 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® 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 clinical claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Both valves are operating within acceptable tolerances.Results: 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.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.Finally, we have dismantled the valves.There were no visible deposits observed inside the valves.Based on our investigation, we are unable to substantiate the claim of occlusion and under-drainage.At the time of our investigation, the valves were shown to be permeable.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
Investigation is done.

• Brand Name: PROGAV 2.0 W. SA2.0 15 A.DIST.CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11588857
• Report Number: 3004721439-2021-00055
• Device Sequence Number: 4183027
• Product Code: JXG
• UDI-Device Identifier: 04041906502058
• UDI-Public: 4041906502058
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2021

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: 10/31/2024
• Device Model Number: FX647T
• Device Catalogue Number: FX647T
• Device Lot Number: 20044489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/12/2021
• 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: 84 YR
• Patient Weight: 55