MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYSTEM WITH CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FX431T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/13/2016
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 valve was manufactured by a qualified employee in september 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® 2.0 has a nominal pressure rating of 0 to 20 cmws.The valve specifications after closing the valve for 5 ml/h or 50 ml/h flow, for set pressure range 0, 10, 20 cmh2o.The valve was inspected as article fx431t.All parameters (opening pressure, reflux, tightness, adjustability and brake function)have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Before release the progav 2.0 was pre-adjusted to pressure setting 5 cmh2o.Device examination: the valve was received submersed in an unidentified liquid in the provided returnkit.At the time of submission the progav 2.0 valve was set to pressure range 16 cmh2o.Visual inspection: no significant deformations or damage to the valve were detected apart from slight scratches on the housing during the visual inspection.Permeability test: a permeability test has shown that the valve was penetrable.Adjustment test: the progav® 2.0 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.Computer controlled test: the test is performed with miethke computer controlled testing apparatus.The valve was tested by simulating a liquor flow between 60 ml/h down to 5 ml/h and up again to 60 ml/h in vertical position (in acc.To iso 7197).Distilled water was used as test-liquid.The progav 2.0 worked reliably within the accepted tolerances.Result: first, a visual inspection of the progav® 2.0 was performed.No significant deformations or damage to the valve were detected apart from slight scratches to the housing during the visual inspection.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve met all specifications.Finally, a computer controlled test was performed, which confirmed that the progav 2.0 worked reliably within the accepted tolerances.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the claim of valve cannot be adjusted was not able to be confirmed.No valve failure was observed.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 miethke that a progav 2.0 system with control reservoir (part # fx431t) was implanted during a procedure performed on (b)(6) 2015.According to the complainant, following the primary surgery, the patient's condition was noted as being fine.However, ventricle hypertrophy was observed during a visit to the hospital in (b)(6) 2016.The issue occurred while attempting to adjust the pressure value of the valve.Reportedly, the pressure value was not able to be adjusted.The patient underwent a revision procedure on (b)(6) 2016.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 2.0 SYSTEM WITH CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12573037
• Report Number: 3004721439-2021-00650
• Device Sequence Number: 4053579
• Product Code: JXG
• UDI-Device Identifier: 04041906137298
• UDI-Public: 4041906137298
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141687
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• 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): 10/04/2021

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: 06/30/2020
• Device Model Number: FX431T
• Device Catalogue Number: FX431T
• Device Lot Number: 20027751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2016
• Initial Report FDA Received Date: 10/04/2021
• 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