MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W/BURRHOLE RESV.9/29; HYDROCEPHALUS MANAGEMENT

Model Number	FV301T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	01/06/2017
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 paedigav® was manufactured by a qualified employee in may 2015.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The paedigav has a fixed pressure of 9cmh20 in the horizontal and 29cmh20 in the vertical position.The valve was inspected as article fv301t.All parameters have been inspected and signed during the manufacturing process.All parameters have been assessed as meeting specification.Device examination: the paedigav® valve was returned submersed in an unidentified liquid.Visual inspection: a visual inspection was performed which revealed no deformations or other abnormalities.Permeability test: a permeability test has shown that the valve was permeable with difficulty.Computer controlled test: to investigate over/under-drainage, the opening pressure was measured using a miethke computer controlled testing apparatus which simulates a cerobrospinal fluid flow.The results showed that the valve was operating within the accepted tolerance in the vertical, but not in the horizontal position.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.Result: first, a visual inspection of the progav® was performed.No significant deformations or damage to the valve were detected.Next, the permeability of the valve was tested.The valve was shown to be permeable with difficulty.As a final examination, a computer controlled test was performed.He results showed that the valve was operating within the accepted tolerance in the vertical, but not in the horizontal position.Finally, the valve was dismantled.A small amount of build-up of a substance (likely protein) was observed inside the valve.Based on the investigation, the valve showed a slower flow of liquid.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 (b)(4).No further regulatory actions are required.
Event or Problem Description
It was reported to miethke that a paedigav system w/burrhole resv.9/29 (part # fv301t) was implanted during a procedure performed on an unknown date.According to the complainant, a dysfunction of the valve occurred.The patient underwent a revision procedure on an (b)(6) 2017.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.

• Brand Name: PAEDIGAV SYSTEM W/BURRHOLE RESV.9/29
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12665329
• Report Number: 3004721439-2021-00685
• Device Sequence Number: 1179329
• Product Code: JXG
• UDI-Device Identifier: 04041906116361
• UDI-Public: 4041906116361
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• 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): 10/20/2021

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: 12/31/2020
• Device Model Number: FV301T
• Device Catalogue Number: FV301T
• Device Lot Number: 20030348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 10/20/2021
• 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