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

Model Number	FV427T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the progav® was manufactured by a qualified employee in august 2014.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav has a normal pressure range of 0 to 20 cmh20.The valve was inspected as article fv427t.All parameters have been inspected and signed during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the prgav® valve was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: a visual inspection was performed which revealed a deformation of the outer housing.Permeability test: a permeability test has shown that the valve was permeable.Adjustment test: the progav was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function was fully operational and the braking force was within expected tolerances.Result: first, a visual inspection of the progav® was performed.A deformation of the outer housing was revealed.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operated as expected and met all specifications.Finally, the valve was dismantled.There were no visible deposits observed inside the valve.Based on the investigation, the claim of mechanical malfunction was not able to be substantiated.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported to miethke that a progav system w/sa 20 a.Sprung reservoir (part # fv427t) and a prosa valve (part # fv701t) (ref.Mdr id 3004721439-2021-00693) were implanted during a procedure performed on an unknown date.According to the complainant, the patient fell down and bumped head.The physician believed mechanical damage to the progav 2.0 and the prosa valve, possibly over-drainage, occurred as a result.The patient underwent a revision procedure on (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Height: 165 centimeters (cm).

• Brand Name: PROGAV SYSTEM W/SA 20 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: 12677224
• Report Number: 3004721439-2021-00692
• Device Sequence Number: 11894670
• Product Code: JXG
• UDI-Device Identifier: 04041906132248
• UDI-Public: 4041906132248
• 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 Explanted Year: 2017
• 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): 10/21/2021

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: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20027350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 10/21/2021
• 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: 48 YR
• Patient Weight: 60