MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 20; HYDROCEPHALUS MANAGEMENT

Model Number FV251T

Device Problem Increase in Pressure (1491)

Patient Problem Hydrocephalus (3272)

Event Date 07/07/2020

Event Type  Injury  

Manufacturer Narrative

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 under-drainage, 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 operates within the accepted tolerance in both positions.Results: first we performed a visual inspection of the shuntassistant®.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 in both positions.Finally, we have dismantled the valve.Inside the valve we have found a significant build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of under-drainage.At the time of our investigation, the valve was operating within the specified tolerances.However, it is possible that the significant deposits observed inside the valve could have caused the malfunction in the past.As described in our 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 there was a problem with a shuntassistant.The reporter suspected an underdrainage.Patient information: age: (b)(6) years.Weight: unknown.Hight: unknown.Gender: unknown.

• Brand Name: SHUNTASSISTANT 20
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10337956
• MDR Text Key: 208204269
• Report Number: 3004721439-2020-00155
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K110206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: FV251T
• Device Catalogue Number: FV251T
• Device Lot Number: 20035179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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: 3 YR