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	Obstruction of Flow (2423); Optical Obstruction (3002)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 sys w/sa15 a.Sprung reservoir (part # fx426t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the reservoir was noted as being full of steam.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deposits with bloody liquid.Deposits in the inlet spout.Permeability test: the test showed that the sprung reservoir is non-permeable.Results: based on our investigation results, we can identify a blockage and significantly deposits in the reservoir.We are assuming that the deposits detected within the reservoir have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.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: 12934733
• Report Number: 3004721439-2021-00324
• Device Sequence Number: 4958205
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: FX426T
• Device Catalogue Number: FX426T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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