MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SHUNTASSISTANT 15; HYDROCEPHALUS MANAGEMENT

Model Number FV250T

Device Problem Infusion or Flow Problem (2964)

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

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available, a follow up report will be submitted.

Event Description

It was reported that under-drainage occurred.The reporter indicated that on (b)(6) 2019 fx431t and fv250t devices were used on an (b)(6) male patient.The devices were used on the right anterior puncture and the initial pressure was 5cmh2o.After the surgery, it was reported there were no problems; however, little by little under-drainage occurred.The surgeon tried 0cmh2o but it did not flow.There were no problems with the function of fx431t so the surgeon removed fx250t.At the revision surgery, the brain pressure was 6cm, per the surgeon there might be a possibility of hypo-cerebrospinal fluid; when the surgeon took fx250t out, the cerebrospinal fluid started to flow.The surgeon wondered if fx250t might have defect inside.Additional details of the event and patient information is not available.

Manufacturer Narrative

Corrected data: height: 156cm.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 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 the vertical positions.The results show that the valve is operating within the accepted tolerance.Results: first, we performed a visual inspection of the valve.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 under-drainage.At the time of our investigation, the valve was operating within the specified tolerances.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.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 gmbh & co.Kg.

• Brand Name: SHUNTASSISTANT 15
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9264695
• MDR Text Key: 183373303
• Report Number: 3004721439-2019-00276
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV250T
• Device Catalogue Number: FV250T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 69