MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA VALVE W..DIST.CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV706T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/10/2022
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 prosa valve (part # fv706t) was implanted during a procedure performed on an unknown date.According to the complainant, approximately three (3) years after implantation, the physician attempted to adjust the pressure with the pressure regulating tool, but the valve pressure failed to change.The patient underwent a revision procedure on (b)(6) 2022.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product investigation is restricted to tracability of manufacturing and quality control data.The prosa® was manufactured by a qualified employee on july 2019.Deviations during assembly did not occur.The product was finally tested as article fv706t and released for packaging and sterilization and was sterilized by miethke.The prosa® has a normal pressure range of 0 to 40 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The valve was pre-adjusted to 20 cmh2o in accordance with the specification.All tested parameters were assessed according to specifications.Conclusion information: an investigation was not possible because no product was sent for investigation.On the basis of the product documentation, we can exclude the presence of a defect at the time of delivery of the prosa®, since this documentation indicates that the valve is in perfect condition.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.Likewise is possible that placing the prosa® messurement tool in a non-central position on the valve may result to adjustment difficulties.Unfortunately, due to the missing sample, we are unable to provide a meaningful analysis.

• Brand Name: PROSA VALVE W..DIST.CATHETER
• 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: 13502144
• Report Number: 3004721439-2022-00012
• Device Sequence Number: 12094140
• Product Code: JXG
• UDI-Device Identifier: 04041906133559
• UDI-Public: 4041906133559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2022

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: 07/24/2024
• Device Model Number: FV706T
• Device Catalogue Number: FV706T
• Device Lot Number: 20043015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2019
• 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 Sex: Unknown