MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number	FV251T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information/ investigation result will be submitted in a supplemental report.
Event or Problem Description
According to the complainant a shunt assistant was suspected to have a blockage.The patient underwent an implant procedure on (b)(6) /2021.The procedure was a lateral ventricular peritoneal shunt placement.Due to the blockage, the shunt needed to be adjusted.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: unknown, weight: unknown, gender: male.Preoperative diagnosis: severe craniocerebral injury, due to car accident.(is the same patient as #(b)(6)).
Additional Manufacturer Narrative
Same patient: medwatch#3004721439-2021-00235.Investigation: visual inspection: the following observations were made during the visual inspection: -particles in the delivery liquid, -deposits on the product.Permeability test: the test showed that the shuntassistant is non-permeable.Computer control test: the computer controlled test is not applicable due the detected blockage in section permeability test.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, slightly deposits were found in shuntassistant.Results: based on our investigation results, we can identify a "blockage" in 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.Even 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.

• Brand Name: SHUNTASSISTANT 20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12521243
• Report Number: 3004721439-2021-00255
• Device Sequence Number: 5174593
• Product Code: JXG
• UDI-Device Identifier: 04041906113209
• UDI-Public: 4041906113209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 06/26/2024
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20042580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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: 49 YR