MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG GAV 2.0 VENTIL 5/35; HYDROCEPHALUS MANAGEMENT

Model Number FX213T

Device Problems Increase in Pressure (1491); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 04/14/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information/investigation results will be provided in a follow-up report.

Event Description

It was reported that there was a preoperative flow problem with a gav 2.0."transmission pressure too high." "malfunction of the new valve detected during surgery, so it was replaced immediately." date of occurence: (b)(6) 2020.We received the information and the product on 05/26/2020.

Manufacturer Narrative

Visual inspection in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: - no deformation of the housing, deposits, etc.Permeability test in detail, the valve was tested for permeability in order to identify the suspected blockage.To check if the gav 2.0 is blocked, we have performed a permeability test on the valve.This test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the gav 2.0 is permeable.Computer controlled test the computer controlled test has shown the opening pressure of the gav 2.0, at a reference flow rate of 20 ml/hr in a vertical position, to be 33,03 cmh2o.This is still within the specified tolerance of 35 cmh2o ± 4 cmh2o.An applied pressure of 35 cmh2o, with the device in the vertical position is expected to have a resultant opening pressure of 35 cmh2o ± 4 cmh2o.Additionally, the gav 2.0 was tested according to standard procedure in the horizontal position.At a fixed opening pressure of 5 cmh2o in the horizontal position, a pressure of 5 cmh2o ± 3 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the horizontal position, the gav 2.0 had a pressure of 5,27 cmh2o.This is within the specified tolerance of 5 cmh2o ± 3 cmh2o.Results based on our investigation, we are not able to substantiate the claim of "transmission pressure too high."" at the time of the investigation, it is not clear to us how the mentioned functional impairment occurred.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.

• Brand Name: GAV 2.0 VENTIL 5/35
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10111005
• MDR Text Key: 193425004
• Report Number: 3004721439-2020-00109
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: FX213T
• Device Catalogue Number: FX213T
• Device Lot Number: 20040954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention