MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 15 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV433T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition), the valve was received in the original packaging.Result: first we performed a visual inspection with the valve.The investigation results that the sterile package indicates evident imprints, maybe caused by too powerful use of the adjustment tool.For further information we tried to adjust the valve from 0 cmh2o up to 20 cmh2o and down again in the same way in steps of 5 cmh2o.It was not possible to adjust the progav valve.The analysis of the brake results it function is damage.The investigation of the parallelism has shown that the housing of the valve is outside the accepted tolerance.In our point of view there is no failure detectable with the valve at the time of delivery.When adjusting a valve preoperatively through the packaging, a moderate force with the adjustment tool is sufficient.Do not use the button.Strong pressure can cause a damage to the housing, which might affect the valve function.It is important to position the adjustment tool in the center of the valve.Please keep the tool in a right angle to the top of the valve.Normally not very much power is necessary to adjust.For pre-operative adjustments we recommend the use of the progav check-mate.No further actions required.
Event or Problem Description
According to the complainant a progav had a failure during use.The patient was originally scheduled for implantation on (b)(6) 2017; the device would not calibrate.The valve was returned to the manufacturer for evaluation.Further details were not provided.

• Brand Name: PROGAV SYS W/SA 15 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: 12892810
• Report Number: 3004721439-2021-00763
• Device Sequence Number: 1491888
• Product Code: JXG
• UDI-Device Identifier: 04041906132453
• UDI-Public: 4041906132453
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: FV433T
• Device Catalogue Number: FV433T
• Device Lot Number: 20026692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2017
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2015
• 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
• Patient Sex: Unknown