MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W.SA25 A.BURRHOLERESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX449T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/28/2023
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 has been reported that a progav shunt system (#fx449t) was unable to adjust the pressure of the valve during implantation.This occurred during surgery on an 8-month-old infant.After implantation, the valve should be normally adjustable, but it was unable to change the high flow rate.This is extremely rare - the valve was replaced with another of the same type.The hospital department had to get a new valve from the or's stock and replace it.This affected the operation time, which was extended by 5 minutes.For the patient, this meant an extension of the operation time, which led to an increased risk.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, a deformation/damage of the outer housing of the progav 2.0 could be determined.Permeability test: a permeability test has shown that all components are permeable.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the braking force cannot be measured due to the non-adjustability of the valve.Internal inspection: after dismantling of the valve, deposits were found.Result: based on our investigation results, we can determine adjustment difficulties in the progav 2.0 valve.The determined damage and the deposits can be named as the cause for the functional impairment.Deposits caused by substances naturally present in the patient's body, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Even small amounts of organic material can affect the integrity of the valve.How the damage to the outer housing occurred is not clear to us at the time of the investigation.However, based on our documentation, it can be ruled out that the valve was shipped with this defect.

• Brand Name: PROGAV 2.0 SYS PED.W.SA25 A.BURRHOLERESERVOIR
• 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: 18498168
• Report Number: 3004721439-2023-00400
• Device Sequence Number: 20869597
• Product Code: JXG
• UDI-Device Identifier: 04041906137755
• UDI-Public: 4041906137755
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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: FX449T
• Device Catalogue Number: FX449T
• Device Lot Number: 20064815
• 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: Not provided
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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 Age: 8 MO
• Patient Sex: Male