MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number	FV250T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the valve, but some deposits on the outlet catheter part were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of over-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 operates within the accepted tolerance in vertical position.Internal inspection : after dismantling of the valve, deposits were found in the inlet and outlet of the valve.Results: based on our examination results, we cannot detect a malfunction at the valve at the time of our examination.The presence of proteins / deposits in the cerebrospinal fluid could impair the function of the valves temporarily.Deposits caused by natural substances in the csf, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of proteins could affect the integrity of the valve.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
It was reported that a shunt assistant 15 (part # fv250t) was implanted during a procedure performed in (b)(6) 2014.According to the complainant, the shunt system was believed to be operating in overdrainage and was difficult to adjust.The patient underwent a revision procedure on (b)(6) 2022.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 130 centimeters (cm).Weight: (b)(6) (kg).Gender: female.Same event as medwatch # 3004721439-2022-00062.

• Brand Name: SHUNTASSISTANT 15
• 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: 13896062
• Report Number: 3004721439-2022-00063
• Device Sequence Number: 17159941
• Product Code: JXG
• UDI-Device Identifier: 04041906113100
• UDI-Public: 4041906113100
• 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 Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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 Model Number: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 20022311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2014
• 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: 8 YR
• Patient Sex: Female
• Patient Weight: 25 KG