MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV 2.0 SYS W/PED.CONTROL RESERV.10/25; HYDROCEPHALUS MANAGEMENT

Model Number FX156T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection the optical inspection showed particles in the reservoir, but no other obvious damage.Permeability test: a permeability test has shown that the valve, the catheter and the reservoir 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 test is not applicable.Results: first, we performed a visual inspection of the gav 2.0.The optical inspection showed particles in the reservoir, but no other obvious damage.Next, we tested the permeability of the valve.The valve, the catheter and the reservoir were shown to be permeable.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 claim of occlusion.At the time of our investigation, the valve was shown to be permeable.However, it is possible that the deposits observed inside the valve could have caused the malfunction in the past.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.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).

Event Description

It was reported that the valve has a blockage.The reporter indicated that a post operative valve has a blockage.The device was explanted.

• Brand Name: GAV 2.0 SYS W/PED.CONTROL RESERV.10/25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9457066
• MDR Text Key: 170423569
• Report Number: 3004721439-2019-00295
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX156T
• Device Catalogue Number: FX156T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO
• Patient Weight: 5