MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 10; HYDROCEPHALUS MANAGEMENT

Model Number	FX640T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the valve were determined but signs of the adjustment tool on the plastic bag could be determined.Permeability test: not applicable, due to the sterile packaging computer controlled test: not applicable, due to the sterile packaging 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 but the braking force measurement is not applicable, due to the sterile packaging.Internal inspection: the internal inspection ist noch necessary results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx640t) was not adjustable preoperatively in the sterile packaging.The complainant's device was returned to the manufacturer for evaluation.No patient was involved.
Additional Manufacturer Narrative
Correction: b1 + e1 + h1.
Event or Problem Description
It was reported that a progav 2.0 shunt system (#fx640t) was not adjustable preoperatively in the sterile packaging.The complainant's device was returned to the manufacturer for evaluation.No patient was involved.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 10
• 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: 18574543
• Report Number: 3004721439-2023-00402
• Device Sequence Number: 20796593
• Product Code: JXG
• UDI-Device Identifier: 04041906501983
• UDI-Public: 4041906501983
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• 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): 01/29/2024

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: FX640T
• Device Catalogue Number: FX640T
• Device Lot Number: 20071018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: 01/29/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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 Sex: Unknown