MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SHUNTSYSTEM; HYDROCEPHALUS MANAGEMENT

Model Number	FX992T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection: it was bloody residues and build-up of tissue were observed through the visual inspection.No significant deformations or damage were detected.Permeability test: a permeability test has shown that the prosa® shuntsystem is permeable.Adjustment test: the prosa® shuntsystem 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 over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The prosa® valve and the progav® 2.0 were operating within acceptable tolerances.Results: first we performed a visual inspection of the prosa® shuntsystem.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 valves, as well as the brake functionality and brake force.The prosa® shuntsystem operates as expected and met all specifications.Finally, we have dismantled the valves.Inside the progav 2.0 valve we have found a slight build-up of substances (likely protein).There were no visible deposits observed inside the prosa valve.Based on our investigation, we are unable to substantiate the claim of over-drainage.At the time of our investigation, the opening pressure of both vales were within the specified tolerances.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in our 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 valve met all specifications of the final inspection when released from christoph miethke (b)(4).
Event or Problem Description
It was reported that there was a problem with a prosa shuntsystem.The reporter suspected an overdrainage.Patient information: age: (b)(6) years.Weight: (b)(6) kg.Hight: 168 cm.Gender: unknown.No further information available.

• Brand Name: PROSA SHUNTSYSTEM
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14460 ; GM 14460
• MDR Report Key: 10747870
• Report Number: 3004721439-2020-00219
• Device Sequence Number: 3312551
• Product Code: JXG
• UDI-Device Identifier: 04041906138431
• UDI-Public: 04041906138431
• 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 Explanted Year: 2020
• 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): 10/26/2020

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 Expiration Date: 06/30/2021
• Device Model Number: FX992T
• Device Catalogue Number: FX992T
• Device Lot Number: 20031638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/28/2020
• 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: 28 YR
• Patient Weight: 70