MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV W.DISTAL CATHETER 4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV272T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation: visual inspection: particles (calcified deposits) are visible of the part of catheter and in the inlet spout, some particles are in the delivery liquid observed trough the visual inspection.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test: this is a fixed pressure valve.A braking force and brake function tests are not applicable.Computer controlled test: to investigate the claim of overdrainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.The results show that the valve is operating within the accepted tolerance in the vertical but not in the horizontal position.The test showed a decreased flow of liquid.Results: first, we performed a visual inspection of the paedigav.Some particles, proteins or other tissue residues are visible on the product, but no defects or other abnormalities.Next, we tested the permeability of the valve.The valve was shown to be permeable.Then we carried out a computer controlled simulated flow test.The measured opening pressure was within the accepted tolerance in the vertical position but not in the horizontal position.The opening pressure was significantly lower than expected and showed a decreased flow of liquid.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the clinical claim of overdrainage.At the time of our investigation, the valve was operating within the specified tolerances in the vertical position.We observed that the valve shows a slower flow of liquid in the horizontal position, 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 hc-therapy by shunt implants.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.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 there was a problem with a paedigav valve.The surgeon suspected that the valve operates in overdrainage and replaced the valve.Patient information: patient information: (b)(6) height: 113 cm gender:male.Date of implantation: unknown (2013) date of removal: (b)(6) 2020.

• Brand Name: PAEDIGAV W.DISTAL CATHETER 4/24
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11116754
• Report Number: 3004721439-2020-00266
• Device Sequence Number: 19821005
• Product Code: JXG
• UDI-Device Identifier: 04041906114800
• UDI-Public: 4041906114800
• 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: 2020
• 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): 12/17/2020

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: 10/06/2018
• Device Model Number: FV272T
• Device Catalogue Number: FV272T
• Device Lot Number: 20021261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• 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: 7 YR
• Patient Weight: 13