MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROSA SYS W/PROGAV 2.0 A.PED.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FX998T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Date of explant: unknown.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "that there was no possibility of subcutaneous parameter changes.Device 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: a deformation of the outer housing of the valve was observed through the visual inspection.The prosa valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at -0.130mm, outside the tolerance of 0 +/- 0.02mm.Permeability test: a permeability test has indicated that the valve has a blockage.Adjustment test: the valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Results: we have dismantled the valve.Inside the valve we have found significant build-up of substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.The valve is adjustable to all specified settings.However, through the investigation we have determined that the prosa valve is occluded, likely due to the deposits obsereved inside the valve.As described in our literature, the problem encountered is one of the known inevitable risks of hc-therapy by shunt implants.

• Brand Name: PROSA SYS W/PROGAV 2.0 A.PED.PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8101867
• MDR Text Key: 128278905
• Report Number: 3004721439-2018-00277
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

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: 12/31/2019
• Device Model Number: FX998T
• Device Catalogue Number: FX998T
• Device Lot Number: 20026762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Distributor Facility Aware Date: 11/05/2018
• Device Age: 3 YR
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention