MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA10 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX432T
Medical Device Problem Codes	Inflation Problem (1310); Use of Device Problem (1670)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/16/2024
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
Preoperative, no patient involvement, limited information product in question: progav 2.0 shuntsystem (fx432t) complaint: when placing the patient in the reservoir, there was air inside the reservoir after ligating the reservoir and the brain catheter.Because the air could not be expelled by pumping, an attempt was made to remove it using a syringe with an injection needle, but the air could not be removed.The use of this product was discontinued and a different product number, the fx433t, was placed in place.
Event or Problem Description
The product was returned in dry condition to the manufacturer for examination.It was reported that the device (#fx432t) could not be used due to the facht that the air in the reservoir could not be expelled by pumping.A replacement product was used and the operation was completed.No complications were reported on the patient.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, a visible cut in the membrane of the reservoir was determined.Permeability test: a permeability test has shown that all components are permeable.The reservoir fills with fluid and drains it again.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected and the braking force is within the given tolerances.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.A reservoir fills up over time and deflates the air slowly.This is a regular process.The ifu advises the aspiration and permeability testing of the shunt system prior to placement in the patient.How the above-mentioned problem came about is not clear to us at the time of the investigation.No further actions are required as a result of the complaint.

• Brand Name: PROGAV 2.0 SYS W/SA10 A.CONTROL RESERVOIR
• 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: 20225094
• Report Number: 3004721439-2024-00282
• Device Sequence Number: 7419108
• Product Code: JXG
• UDI-Device Identifier: 04041906137304
• UDI-Public: 4041906137304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/30/2024

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 Expiration Date: 04/18/2024
• Device Model Number: FX432T
• Device Catalogue Number: FX432T
• Device Lot Number: 20074776
• 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: 09/24/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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
• Patient Sex: Unknown