MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDI-SHUNTASSISTANT 10; HYDROCEPHALUS MANAGEMENT

Model Number	FV288T
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
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a paedi shuntasisstant (part # fv288t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to have a shunt dysfunction.The patient underwent a revision procedure.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: 148 centimeters (cm), weight: (b)(6) gender: unknown.Its same patient as mdr id #3004721439-2021-00345 and mdr id # 3004721439-2021-00347.
Additional Manufacturer Narrative
Manufacturing and quality control data the paedisa was manufactured by a qualified employee on (b)(6) 2020.Deviations during assembly did not occur.The product was finally tested as article fv288t and released for packaging and sterilization and was sterilized by miethke.The paedisa has a fixed pressure of 10 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at a fixed pressure of 10 cmh2o, and were found to meet range the tolerances.All tested parameters were assessed according to specifications.Visual inspection deposits on the valve permeability test the test showed that the paedisa is permeable.Computer control test the computer controlled test showed the opening pressure of the paedisa, at a reference flow rate of 20 ml/h in a vertical position of the valve, to be 9,2 cmh2o.This is within the specified tolerance of 10 cmh2o + 4 cmh2o and -2 cmh2o.An applied pressure of 10 cmh2o, with the device in the vertical position is expected to have a resultant pressure of 10 cmh2o + 4 cmh2o and -2 cmh2o.Internal inspection of product after dismantling of the valve, some deposits were found in the paedisa.Results based on our investigation results, we cannot identify a malfunction in the valve.However, we assume that the significant deposits found within the valve may have temporarily 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.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.
Event or Problem Description
Investigation is done.

• Brand Name: PAEDI-SHUNTASSISTANT 10
• 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: 13193800
• Report Number: 3004721439-2021-00346
• Device Sequence Number: 17207963
• Product Code: JXG
• UDI-Device Identifier: 04041906113001
• UDI-Public: 4041906113001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2022

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: 04/20/2025
• Device Model Number: FV288T
• Device Catalogue Number: FV288T
• Device Lot Number: 20047437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Unknown
• Patient Weight: 48 KG