MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0; HYDROCEPHALUS MANAGEMENT

Model Number	FX602T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Examnitation of the device is not applicable as the valve is still implanted.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 progav 2.0 (#fx602t) was implanted during a procedure performed on an unknown date.According to the complainant, after a preventive check up, the adjustment did not work.However, the patient was fine and has no symptoms, so a revision was not performed.Therefore, the complaint device was not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Description of complaint on may 25, 2022 we received knowledge about a complaint.We were informed that a valve is not adjustable.At that time the patient showed no symptoms.A revision was not performed.However, additional information was received on august 08, 2022 which revealed that the device was explanted.Further product information was not made available.The clinic stated the sample was not available for investigation.Manufacturing and quality control data because the serial number of the device is unknown we are not able to trace production and quality control data.We confirm all parameters have been inspected and approved during the manufacturing.We assure that production and quality control ensure that only products that conform to specifications are made available on the market.Conclusion information: an investigation was not possible because the product is not available.With reference to the reason for the complaint, we would like to point out that deposits in the valve could be responsible for 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.Due to missing information (patient data, serial number, device itself), we are unable to provide a meaningful analysis.
Additional Manufacturer Narrative
Investigation on-going.Should relevant additional information/ investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
Additional information was received which revealed that valve was explanted.The date that the explantation was performed is not known.

• Brand Name: PROGAV 2.0
• 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: 14776436
• Report Number: 3004721439-2022-00175
• Device Sequence Number: 11096448
• Product Code: JXG
• UDI-Device Identifier: 04041906503222
• UDI-Public: 4041906503222
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2022

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 Model Number: FX602T
• Device Catalogue Number: FX602T
• 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: 05/25/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 08/29/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 08/30/2022; 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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