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

Model Number	FV252T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/23/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to miethke that a shuntassistant 25 (part # fv252t) was implanted during a procedure performed in (b)(6) 2017.According to the complainant, the shunt assistant was believed to be underdrainage.The patient underwent a revision procedure on (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.Further details were not provided.Height : 52cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: visual inspection: no significant deformations or other abnormalities of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve has a blockage.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 valve is tested in both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not possible.Result: first, we performed a visual inspection of the shunt assistant.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to have a blockage.Finally, we have dismantled the valve.Inside the valve we have found a small amount of build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of occlusion.At the time of our investigation, the valve was shown to be permeable.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 hg-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 25
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12790799
• Report Number: 3004721439-2021-00727
• Device Sequence Number: 3808134
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2021

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: 11/10/2021
• Device Model Number: FV252T
• Device Catalogue Number: FV252T
• Device Lot Number: 20032226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 MO
• Patient Sex: Unknown
• Patient Weight: 4 KG