MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number FX103T

Device Problem Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Investigation: visual inspection: no significant deformations or damage of the valve were detected during 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 test is not applicable.Computer controlled test: to investigate the claim of over- drainage, the opening pressure is measured using a miethke computer controlled testing apparatus, which simulates a cerebrospinal fluid flow.The valve is tested in the vertical position.The results show that the valve operates within the accepted tolerance.Results first, we performed a visual inspection of the shunt assistant 2.0.No significant deformations or damage of the valve were detected during the visual inspection.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.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we are unable to substantiate the claim of occlusion and over- drainage.At the time of our investigation, the valve was shown to be permeable and the measured opening pressure was within the accepted tolerance.Despite the lack of significant deposits, it is possible that even non-visible or small amounts of build-up could have led to a temporary compromise of the valve and to the observed 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 gmbh & co.Kg.

Event Description

It was reported that the valve was blocked/overdrain the reporter indicated that a 1 month 13 day post operative valve is blocked and overdrain requiring explantation.Additional details of the event are not available.

• Brand Name: SHUNTASSISTANT 2.0 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: 9119599
• MDR Text Key: 165461554
• Report Number: 3004721439-2019-00234
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX103T
• Device Catalogue Number: FX103T
• Device Lot Number: 20042138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2019
• 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: 16 YR
• Patient Weight: 50