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

Model Number	FV701T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Headache (1880)
Date of Event	09/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap inc.That a prosa valve (part # fv701t) was implanted during a primary procedure performed on (b)(6) 2019.According to the complainant, the valve setting adjusted without intervention.Reportedly, the last valve adjustment was performed approximately two (2) years ago, when it was set to eleven (11).On (b)(6) 2022, the patient came into the clinic claiming to have been feeling worse.At that time, the valve was discovered to have changed from eleven (11) to four (4) without programming.The shunt was adjusted back to eleven (11).Additionally, the patient had a magnetic resonance imaging (mri) procedure prior to their visit to the clinic.No revision surgery is scheduled at this time.Therefore, the complaint device was not available to be returned to the manufacturer for evaluation.
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
Investigation complete.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product, the investigation is restricted to traceability of manufacturing and quality control data.The prosa was manufactured by a qualified employee on november 2018.Deviations during assembly did not occur.The product was finally tested as article fv701t 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, 10, 20, 30 and 40 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 the product is still implanted.On the basis of the product documentation,we can exclude a defect at the time of delivery of the prosa, since this documentation indicates that the valve is in perfect condition.The cause of the self- adjustability could not be determined.A meaningful conclusion requires an examination of the product.Further actions: from our point of view, no further regulatory actions are required.

• Brand Name: PROSA VALVE
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 15546440
• Report Number: 2916714-2022-00099
• Device Sequence Number: 6585131
• Product Code: JXG
• UDI-Device Identifier: 04041906133023
• UDI-Public: 4041906133023
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022
• Report Date (Section F): 10/05/2022

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: 11/29/2023
• Device Model Number: FV701T
• Device Catalogue Number: FV701T
• Device Lot Number: 20040014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/15/2022
• Device Age: 45 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 10/20/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 10/05/2022