MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX648T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: scratches on the outer housing of the valve and particles in the delivery liquid were observed through the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.During investigation bloody fluid including small particles leaked from the valve.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Click/brake force and brake function test: the click force of the progav 2.0 was within the permissible specification and the function of the brake could be tested without any problems.Result: first, we performed a visual inspection of the progav 2.0.Significant scratches and particle sin the delivery liquid were observed through the visual inspection.Next, we tested the permeability, adjustability, as well as the brake functionality and klick force.The valve operates as expected and met all specifications.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances.Based on our investigation, we are unable to substantiate the claim of malfunction.At the time of our investigation, the valve was shown to be fully functional.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further regulatory actions are required from our point of view.
Event or Problem Description
It was reported that a progav 2.0 (#fx648t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the shunt system was believed to be not adjustable to all pressure settings.The patient underwent a revision procedure on (b)(6) 2021.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6) years.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12372414
• Report Number: 3004721439-2021-00238
• Device Sequence Number: 19814462
• Product Code: JXG
• UDI-Device Identifier: 04041906502065
• UDI-Public: 4041906502065
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2021

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: 03/01/2026
• Device Model Number: FX648T
• Device Catalogue Number: FX648T
• Device Lot Number: 20052052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 08/26/2021
• 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: 58 YR