MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20 W/ATT DISTAL CATH; HYDROCEPHALUS MANAGEMENT

Model Number	FV261T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: no abnormalities permeability test: the test showed that the shunt assistant is permeable.Computer control test: the computer controlled test showed the opening pressure of the shunt assistant, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 15.29 cmh2o.This is not within the specified tolerance of 20 cmh2o +4/-2 cmh2o.An applied pressure of 20 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 20 cmh2o +4/-2 cmh2o.Additional testing did not significantly change the results.According to our results, we determine a presence of an accelerated outflow.Internal inspection of product: in order to verify whether the investigated valve was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the valve.After dismantling of the valve, some deposits were found in shunt assistant.Results: based on our investigation results, we can identify an accelerated outflow at the valve.We are assuming that the deposits detected within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise 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.From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a shunt assistant (part # (b)(4)) was implanted during a procedure performed on (b)(6) 2020.According to the complainant, the shunt system was believed to be operated in underdrainage.The patient underwent a revision procedure on (b)(6) 2021.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: 85 centimeters (cm), weight: (b)(6) (kg), gender: unknown.Same event as medwatch #: 3004721439-2021-00361.

• Brand Name: SHUNTASSISTANT 20 W/ATT DISTAL CATH
• 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: 13388279
• Report Number: 3004721439-2021-00363
• Device Sequence Number: 19286991
• Product Code: JXG
• UDI-Device Identifier: 04041906114206
• UDI-Public: 4041906114206
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 01/28/2022

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 Expiration Date: 01/21/2025
• Device Model Number: FV261T
• Device Catalogue Number: FV261T
• Device Lot Number: 20045700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2020
• 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: 26 MO
• Patient Sex: Unknown
• Patient Weight: 11 KG