MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT,

Model Number	FX103T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
It was reported that a shuntassistant 2.0 (#fx103t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the valve was believed to be operated in underdrainage.The patient underwent a revision procedure.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) height: 60 cm weight: (b)(6) gender: female.
Additional Manufacturer Narrative
Same event: mdr#3004721439-2021-00148.Investigation: visual inspection: no significant deformations or damage of the shuntassistant were detected during the visual inspection.The returned valves were connected with a bactiseal catheter.Permeability test: a permeability test has shown that the valve is permeable.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 results show that the valve is not operating within the acceptable tolerance in the vertical position.Results: first, we performed a visual inspection of the shuntassistant.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability and opening pressure of the valve.The opening pressure of the valve was out of tolerance, but all other specifications were met.The measured values show a slightly accelerated outflow.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).In advance, we would like to point out that the permeability test has already been done after the revision on clinic part.Based on our test results, we can detect accelerated outflow at the shuntassistant at the time of our investigation.We suspect that the deposits found inside the valve have led to the functional impairment.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.

• Brand Name: SHUNTASSISTANT 2.0 25
• Common Device Name: HYDROCEPHALUS MANAGEMENT,
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11878552
• Report Number: 3004721439-2021-00149
• Device Sequence Number: 19643795
• Product Code: JXG
• UDI-Device Identifier: 04041906501594
• UDI-Public: 4041906501594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 11/03/2025
• Device Model Number: FX103T
• Device Catalogue Number: FX103T
• Device Lot Number: 20050336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: 4 MO
• Patient Weight: 5