MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV434T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav had overdrainage postoperatively and could not be adjusted.The valve was implanted on an unspecified date in 2015.It was removed in 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.Height: 170 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the valve was returned in an unknown liquid.Result: in the visual inspection of the valve, we could not detect any apparent damage.The examination of the parallelism, however, showed a slight deformation.To investigate if the assumed blockage has affected the product performance we performed a permeability test.The test results that the progav valve was penetrable.We tried to adjust the valve from 0 up to 20 cmh2o in steps of 5 cmh2o and down again in the same way.However, it was not 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 tried to carry out a brake function test.But the investigation of the braking force has resulted that the valve cannot not be adjusted.Accordingly, the braking force cannot be measured.Given the fact that during the treatment with shunts the following complications may arise: infections, blockages caused by protein and/ or blood in the cerebrospinal fluid, over/ under drainage, we decided to dismantle the valve.Inside the progav we found apparent of protein.After opening the progav valve, we could not detect any deposits.Based on our test results, we can to confirm cannot be adjusted of the progav, maybe the deposits inside the valve could have affected the function 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 miehtke (b)(4).No further actions required.

• Brand Name: PROGAV SYS W/SA 20 A.CONTROL 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: 12925710
• Report Number: 3004721439-2021-00788
• Device Sequence Number: 12202723
• Product Code: JXG
• UDI-Device Identifier: 04041906132460
• UDI-Public: 4041906132460
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2021

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: 12/31/2019
• Device Model Number: FV434T
• Device Catalogue Number: FV434T
• Device Lot Number: 20025362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2015
• 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 Age: 84 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG