MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 25; HYDROCEPHALUS MANAGEMENT

Model Number	FV252T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of the product is still pending.When additional informations are provided, a follow up will be submitted.
Event or Problem Description
It was reported that there was a problem with a shuntassistant.The surgeon suspected that the valve operates in overdrainage and malfunction.Patient information age: (b)(6) years.Weight: (b)(6) kg.Height: 170 cm.Gender: female.Date of implantation: (b)(6) 2019.Date of removal: (b)(6) 2020.
Additional Manufacturer Narrative
Investigation result: visual inspection: visual inspection showed significant external tissue/protein adhesions.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve operates within the accepted tolerance in vertical position.Results: first, we performed a visual inspection of the valve.It showed significant external tissue/protein adhesions, but no significant deformations or damage of the valve were detected.Next, we tested the permeability and the computer controlled test.The valve is permeable and the measured opening pressure was within the accepted tolerance in the vertical position.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of over-drainage.At the time of our investigation, the valve was operating 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 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 valve 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
The investigation of the device was completed and would be submitted with this report.

• Brand Name: SHUNTASSISTANT 25
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11089800
• Report Number: 3004721439-2020-00267
• Device Sequence Number: 3310893
• Product Code: JXG
• UDI-Device Identifier: 04041906113308
• UDI-Public: 4041906113308
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/08/2021

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: 03/22/2023
• Device Model Number: FV252T
• Device Catalogue Number: FV252T
• Device Lot Number: 20037193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/26/2021
• 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: 20 YR
• Patient Weight: 50