MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV 2.0 VALVE; HYDROCEPHALUS VALVES

Model Number FX410T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 11/23/2018

Event Type  Injury  

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 "1y 7m po valve is not adjustable, there is blockage.Explanted.".

Manufacturer Narrative

The valve was received submerged in an unidentified liquid in a plastic container.No deformation or damage of the valve were detected during the visual inspection.The permeability test shown that the progav 2.0 valve is permeable.The progav 2.0 valve was tested and is not adjustable throughout the normal range.The braking functionality test has shown that the brake function is operational, however the braking force cannot be measured due to the non-adjustability of the valve.To test the opening pressure, we used (b)(6) computer controlled testing apparatus which stimulates a cerebrospinal fluid flow.The progav 2.0 valve is not operating within acceptance tolerances.We performed a visual inspection of the prosa 2.0 valve.No deformation or damage of the valve were detected during the visual inspection.Then we tested the permeability, adjustability, and opening pressure of the valve.The progav2.0 valve was permeable but could not be adjusted to all settings.Furthermore, the opening pressure was measured to be significantly less than the specified tolerance, indicating a tendency towards over drainage.Next we measured the brake functionally and braking force of the valve.The brake functionality operated as expected, however the brake force could not be measured due to the inability of the valve to hold a set pressure.Finally, we have dismantled the valve.Inside the prosa we have found a buildup of substance (likely protein).Based on our investigation, we confirm that the valve is non-adjustable, likely due to the deposits observed inside the valve.Furthermore, we have determined that instead of the claimed under drainage that the valve is operating in a state of over-drainage that the valve is operating in a state of over drainage.This could also be attributed to the deposits observed inside the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspections.

• Brand Name: PROGAV 2.0 VALVE
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8157950
• MDR Text Key: 130164007
• Report Number: 3004721439-2018-00293
• 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: 12/21/2018

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 Expiration Date: 12/06/2021
• Device Model Number: FX410T
• Device Catalogue Number: FX410T
• Device Lot Number: 20032484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Distributor Facility Aware Date: 12/07/2018
• Device Age: 2 YR
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 11