MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV438T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/25/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: the valve was received submersed in an unidentified liquid in the provided return kit.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Results: first, we performed a visual inspection of the valve.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we are unable to substantiate the clinical claim of under-drainage.At the time of our investigation, the opening pressure of the valve was within the specified tolerances.How a functional impairment of the valve could occur in the past is not revealed to us throughout our investigations.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 actions required.
Event or Problem Description
According to the complainant a progav was suspected of postoperative blockage or under-drainage.The patient was originally implanted on (b)(6) 2014.The explant date was (b)(6) 2016.The valve was returned to the manufacturer for evaluation.Further details were not provided.Height: 173 cm.

• Brand Name: PROGAV SYSTEM PED.WITH PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12468634
• Report Number: 3004721439-2021-00627
• Device Sequence Number: 19781698
• Product Code: JXG
• UDI-Device Identifier: 04041906132514
• UDI-Public: 4041906132514
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

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: FV438T
• Device Catalogue Number: FV438T
• Device Lot Number: 20022938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 09/14/2021
• 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: 60 YR
• Patient Weight: 95