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

Model Number	FX597T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: yellowish signs on the catheter, but no significant deformations or damage of the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The results show that the valve is operating not within the accepted tolerance in the vertical position.Internal inspection : after dismantling of the valve, no deposits were found in shuntassistant 2.0.Results: based on our examination results, we can detect an accelerated outflow at the valve at the time of our investigation.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a shuntassistant 2.0 (part # fx597t) was implanted during a procedure performed on an unknown date.According to the complainant, the shunt system was believed to be operating in underdrainage.The patient underwent a revision procedure on (b)(6) 2021.Only the shuntassistant 2.0 was removed.No malfunction of the valve was suspected by the physician; the surgeon believed that the gravitational unit was not tolerated because the patient has had a differential pressure unit for whole life.The patient underwent a revision procedure on (b)(6) 2021 and the shuntassistant 2.0 was removed.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6), height: unknown, weight: unknown, gender: female.

• Brand Name: PROGAV 2.0 SYS SA2.0 25 A.PED.PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12388713
• Report Number: 3004721439-2021-00250
• Device Sequence Number: 4724114
• Product Code: JXG
• UDI-Device Identifier: 04041906503543
• UDI-Public: 4041906503543
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2021

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 Expiration Date: 04/14/2025
• Device Model Number: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20047376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR