MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
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 march 2012.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 cmh2o.The shunt system was inspected as article fv435t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Device examination: the progav® was returned in a plastic container submersed in an unidentified liquid.Visual inspection: scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damage were detected.The progav® valve housing was subsequently measured and indicated the presence of a deformation.Permeability test: a permeability test has shown that the valve has reduced permeability.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, however, the braking force was not within expected tolerances.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected during the visual inspection, however, a deformation was detected through a measurement of the plane parallelity.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve had reduced permeability and the braking force required was not within the given specifications.All other specifications were met.Finally, the valve was dismantled.A small amount of build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, a reduction in the braking force was observed which was likely due to the blow sustained to the patients head.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.
Event or Problem Description
It was reported to miethke that a progav sys w/sa 25 a.Control reservoir (part # fv435t) was implanted during a procedure performed on an unknown date.According to the complainant, the patient sustained a blow to the head which required that the valve be explanted.The patient underwent a revision procedure on an unknown date.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12586809
• Report Number: 3004721439-2021-00670
• Device Sequence Number: 3289237
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20016178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2016
• Initial Report FDA Received Date: 10/06/2021
• 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