MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS W/SA15 A.SPRUNG RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX426T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/19/2022
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
According to the complainant, prior to use, a leak on the reservoir side of the progav 2.0 shuntsystem (part # fx426t) was observed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported.Age: unknown.Weight: 172 kilograms (kg).Height: 80 centimeters (cm).Gender: male.
Additional Manufacturer Narrative
Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damage, deformation of the housing, deposits or other abnormalities.The following observations were made during the visual inspection: bloody deposits externally.Bloody deposits in ventricular catheter holes.Outlet catheter ligated.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the sprung reservoir upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the sprung reservoir and the ventricular catheters are permeable.Results: based on our examination results, we cannot detect any slowed outflow on the sprung reservoir with peritoneal catheter.We could detect bloody deposits on the srung resrvoir as well as on the holes of the catheter.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.Further actions: from our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYS W/SA15 A.SPRUNG 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: 16028916
• Report Number: 3004721439-2022-00390
• Device Sequence Number: 5476303
• Product Code: JXG
• UDI-Device Identifier: 04041906136963
• UDI-Public: 4041906136963
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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 Expiration Date: 02/01/2026
• Device Model Number: FX426T
• Device Catalogue Number: FX426T
• Device Lot Number: 20051684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2021
• 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: Male
• Patient Weight: 172 KG