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

Model Number	FX417T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Permeability test: the investigation showed that the progav 2.0 with peritoneal catheter is not permeable.To verify which of the two components caused to the non-permeability, both components were individually tested for permeability.The investigation showed that the progav 2.0 is permeable, however, the peritoneal catheter is not visual inspection: visual inspection revealed the following: - after opening the kink protection, a twisting of the peritoneal catheter could be detected.Result: based on our examination results, we can determine non-permeability of the peritoneal catheter.The cause of this is the detected twisting on the catheter under the kink protection.Every catheter is tested 100% for permeability.The fact that a blockage of this type was not detected can only be attributed to an individual error.We have initiated measures that will prevent a recurrence of such a case in the future.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 (part # fx417t) was to be implanted during a procedure performed on (b)(6), 2023.According to the complainant, the valve could not be filled before use.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported.

• Brand Name: PROGAV 2.0 WITH 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: 16820391
• Report Number: 3004721439-2023-00101
• Device Sequence Number: 7096165
• Product Code: JXG
• UDI-Device Identifier: 04041906136598
• UDI-Public: 4041906136598
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• 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
• Report Date (Section B): 04/26/2023

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: FX417T
• Device Catalogue Number: FX417T
• Device Lot Number: 20061212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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