MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA10 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX418T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Place of manufacture rating: no product will be returned as it was disposed of at the hospital.If relevant additional information/investigation results are nevertheless available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a progav 2.0 shunt system (# fx418t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the progav 2.0 could not be adjusted.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant's device will not be returned to the manufacturer for evaluation as it was disposed of at the hospital.No patient complications were reported as a result of the revision procedure.No patient data are known.Same event as # 3004721439-2024-00119.

• Brand Name: PROGAV 2.0 WITH SA10 AND DISTAL CATHETER
• 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: 19335118
• Report Number: 3004721439-2024-00120
• Device Sequence Number: 3063135
• Product Code: JXG
• UDI-Device Identifier: 04041906136604
• UDI-Public: 4041906136604
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2024

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
• Device Model Number: FX418T
• Device Catalogue Number: FX418T
• Device Lot Number: 20059971
• 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: 04/23/2024
• Initial Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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