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

Model Number	FV346T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported that a gav system (part # fv346t) was implanted during a procedure performed on an unknown date.According to the complainant, the valve was believed to be operated in over-drainage.The ventricles of the patient were narrowed.The patient underwent a revision procedure.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Although requested, no further information has been made available.The same event: medwatch # 3004721439-2021-00093.
Event or Problem Description
Investigation is done.
Additional Manufacturer Narrative
Manufacturing and quality control data the gav® was manufactured by a qualified employee in september 2009.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a fixed pressure of 5 cmh2o in the horizontal and 30 cmh2o in the vertical position.The valve was inspected as article fv346t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Visual inspection significant blood and tissue residue and a rupture in the catheter.Permeability test a permeability test has indicated that the valve has a blockage.Results it should be noted that the product was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First, we performed a visual inspection of the gav®.Significant blood and tissue residue and a rupture in the catheter.Next, we tested the permeability of the valve.The valve was shown to have a blockage.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we have detected the presence of occlusion in the valve.Likely due to dried not visible deposits inside the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: GAV SYSTEM W.SPRUNG RESERVOIR 5/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11720502
• Report Number: 3004721439-2021-00094
• Device Sequence Number: 14459628
• Product Code: JXG
• UDI-Device Identifier: 04041906131524
• UDI-Public: 4041906131524
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: FV346T
• Device Catalogue Number: FV346T
• Device Lot Number: 20009749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 05/25/2021
• 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