MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV VALVE; HYDROCEPHALUS VALVES

Model Number FV410T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Implant date: unknown.Explant date: unknown.Expiration date: unknown.Batch number: unknown.Height cm: 108.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "adjustment problems." additional patient outcome and medical intervention information has been requested.When the additional information is received a follow up report will be submitted.

Manufacturer Narrative

Investigation: the the first step of our investigation, we performed a visual examination of the valve.The optical inspection showed scratches, but no apparent deformation of the housing surface or other significant damages.Permeability was also tested, and we found that the valve was permeable.With the aide of a dial guage, we tested the parallelism of the valve body.The values measured are outside of tolerance.Next we test the adjustability of the valve, and found that the valve was adjustable to all pressures.The braking force function was found to be below specification.The deformation of the valve housing is the cause.A fall or strike to the patients head may have affected the integrity of the valve.To verify whether the valve examined here was also influenced by the known risks of hc therapy, we have opened the valve.After opening the valve, deposits were detected.

• Brand Name: PROGAV VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157907
• MDR Text Key: 130168960
• Report Number: 3004721439-2018-00304
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV410T
• Device Catalogue Number: FV410T
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/14/2018
• Date Manufacturer Received: 12/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 14