MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM SA2.0 15 AND PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX538T
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
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 progav 2.0 shuntsystem (#fx538t) damaged prior to use.No patient injury was reported.The complained device will be send to manufacturer for examination.
Event or Problem Description
It was reported that a progav 2.0 shuntsystem (#fx538t) damaged prior to use.No patient involvement/injury was reported.The product has been sent to the manufacturer and has been investigated.
Additional Manufacturer Narrative
The valve was sent to us unused in its original sterile packaging.That means that the scope of the examination is limited to the visual inspection and the examination of the adjustability of the valve.During our investigation we were able to determine that the adjustability of the progav 2.0 functions as described in the specifications and we could not determine any other functional deviations or abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.The examination of the return has been completed with the drafting of this report.

• Brand Name: PROGAV 2.0 SYSTEM SA2.0 15 AND PRECHAMBER
• 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: 21101784
• Report Number: 3004721439-2024-00417
• Device Sequence Number: 8934843
• Product Code: JXG
• UDI-Device Identifier: 04041906503468
• UDI-Public: 4041906503468
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FX538T
• Device Catalogue Number: FX538T
• Device Lot Number: 20074407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• 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