MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG SHUNTASSISTANT 15; HYDROCEPHALUS VALVES

Model Number FV250T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 11/21/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).When additional information is received, a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "8y 2m po overdrainage of the valve.Explanted.".

Manufacturer Narrative

Manufacturing and quality control data: all parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Investigation: visual inspection: scratches on the outer housing of the valve were observed through the visual inspection.No significant deformations or damages were detected.Permeability test: a permeability test has shown that the valve is permeable.However a partial blockage was indicated by slow drainage during the test.Computer controlled test: to test the opening pressure, we use a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve was tested in the vertical position.The results show that the valve is operating within the accepted tolerance.Results: we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on out investigation, we are unable to substantiate the claim of overdrainage.The valve operates within the specified tolerances.However, it is possible that the 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.

• Brand Name: SHUNTASSISTANT 15
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157851
• MDR Text Key: 130169722
• Report Number: 3004721439-2018-00296
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K110206
• 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: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: FV250T
• Device Catalogue Number: FV250T
• Device Lot Number: 4502844673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Distributor Facility Aware Date: 11/27/2018
• Device Age: 8 YR
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 48