MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 25 A.CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number	FX603T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fx603t) would be implanted during a procedure on (b)(6), 2023.According to the complainant, the shunt system was believed to be blocked.This problem was detected during the operation of the patient.The complaint device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the procedure.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the missing product investigation is restricted to tracability of manufacturing and quality control data.The progav 2.0 shunt system was manufactured by a qualified employee in february 2023.Deviations during assembly did not occur.The product was finally tested as article fx603t and released for packaging and sterilization and was sterilized by miethke.The progav 2.0 has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The valve was pre-adjusted to 5 cmh2o in accordance with the specification.The shuntassistant 2.0 has a fixed pressure of 25 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at a fixed pressure of 25 cmh2o, and were found to meet range the tolerances.All tested parameters were assessed according to specifications.Conclusion information : an investigation was not possible because no product was return for investigation.Based on the traceability data and the final tests before packing and shipping, no functional deviation can be determined.All tests were successfully completed according to the product specification.At this time, the reason for the above-mentioned problem is unclear.Due to the missing sample for examination, a meaningful analysis is not possible.Likewise, we cannot make a meaningful analysis based on the submitted pictures.
Event or Problem Description
No sample available.The clinic describes the case as follows: the connected peritoneal catheter of the progav 2.0 shuntsystem (#fx603t) had an internal blockage at the time of manufacture which did not allow the flow of csf.The blockage was noticed at the time of surgery.The valve was not impossible to install only the procedure had to be changed.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 A.CONTROL RES.
• 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: 16961285
• Report Number: 3004721439-2023-00152
• Device Sequence Number: 5238700
• Product Code: JXG
• UDI-Device Identifier: 04041906503239
• UDI-Public: 4041906503239
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K190174
• 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,Followup
• Report Date (Section B): 08/11/2023

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: FX603T
• Device Catalogue Number: FX603T
• Device Lot Number: 20063726
• 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: 04/21/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2023
• 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