MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV SYSTEM W.PRECHAMBER 10/30; HYDROCEPHALUS MANAGEMENT

Model Number	FV331T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/08/2016
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 gav valve was manufactured by a qualified employee in july 2010.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The valve has a normal pressure rating of 10 to 30 cmws.The valve was inspected as article fv428t.All parameters (opening pressure, reflux, tightness) have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the valve was received dry without liquid in a plastic container.Visual inspection: no significant deformations or damage to the valve were detected during the visual inspection.Permeability test: a permeability test has shown that the valve was not penetrable.Adjustment test: an adjustment test was not applicable as the valve has a fixed pressure.Braking force and brake function test: a braking force and brake function test were not applicable as the valve has a fixed pressure.Result: it should be noted that the valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items was not significant due to the affect dry deposits of liquor and blood can have on product performance.A visual inspection of the gav valve was performed.No significant deformations or damage to the valve were detected during the visual inspection.Next, the valve permeability was tested, which revealed that the valve was not penetrable.Finally, the valve was dismantled.A build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the valve was found to be occluded.This was likely due to the deposits observed inside the valve.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hydrocephalus (hc)-therapy by shunt implants.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 gav system w.Prechamber 10/30 (part # fv331t) was implanted during a procedure performed on an unknown date.According to the complainant, the device was not draining.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: GAV SYSTEM W.PRECHAMBER 10/30
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12529676
• Report Number: 3004721439-2021-00672
• Device Sequence Number: 5121942
• Product Code: JXG
• UDI-Device Identifier: 04041906127107
• UDI-Public: 4041906127107
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/24/2021

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: FV331T
• Device Catalogue Number: FV331T
• Device Lot Number: 20027511
• 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: 10/26/2016
• Initial Report FDA Received Date: 09/24/2021
• 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