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

Model Number	FX352T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
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.At the time of submission for investigation, the valve was set to pressure range 6 cmh2o.Visual inspection: no significant deformations or damage of the valve were detected during the visual inspection.Result: first we performed a visual inspection with valve.We could not detect any deformations or other abnormalities.In the visual inspection of the valve, we could not detect any apparent damage.It was possible to adjust the valve up and down again in steps of 5 cmh2o.To proof if the brake function is full in place we carried out a brake function test.The investigation has shown that the brake function is present.In the further course of the investigation, we tested the valve positively to permeability.Given the fact that during the treatment with shunts the following complications may arise (as described in the literature): infections, blockages caused by protein and/or blood in the cerebrospinal fluid, we decided to dismantle the valve.Inside the progav 2.0 we found some deposits or substances of protein, which might could be the reason for complications with the adjustability in the past.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 unable to be adjusted postoperatively.The patient was originally implanted on an unspecified date.The event date was not noted.It was possible that the adjustable part of the valve had been directly under the suture line.The valve was explanted and returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV 2.0 WITH SA15 A.SPRUNG RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12506586
• Report Number: 3004721439-2021-00656
• Device Sequence Number: 14744732
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

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: FX352T
• Device Catalogue Number: FX352T
• Device Lot Number: 20025428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 09/21/2021
• 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: 21 MO