MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV SYSTEM W.PRECHAMBER 5/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV328T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) the valve was received submersed in an unidentified liquid in the provided returnkit.Result: first we performed a visual inspection of the progav.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability of the valve.The valve was shown to have a blockage.Then we carried out a computer controlled simulated flow test.The measured opening pressure was within the accepted tolerance in both positions.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.We suspect that possible deposits, which could have been responsible for blockage in the past were flushed out by the computer controlled test.Based on our investigation, we are unable to substantiate the clinical claim of underdrainage.At the time of our investigation, the valve was operating within the specified tolerances.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a gav system was blocked or under-draining postoperatively.The patient was originally implanted on (b)(6) 2015 (abdominal).The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.Height: 165 cm.

• Brand Name: GAV SYSTEM W.PRECHAMBER 5/30
• 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: 12892817
• Report Number: 3004721439-2021-00757
• Device Sequence Number: 1491893
• Product Code: JXG
• UDI-Device Identifier: 04041906126803
• UDI-Public: 4041906126803
• 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 Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FV328T
• Device Catalogue Number: FV328T
• Device Lot Number: 20024513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown
• Patient Weight: 80 KG