MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.; HYDROCEPHALUS VALVES

Model Number FX435T

Device Problem Obstruction of Flow (2423)

Patient Problem Failure of Implant (1924)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Height cm: 110.When additional information is received a follow up report will be submitted.

Event Description

It was reported by the healthcare professional "4d po valve is blocked.Explanted." all med watch submissions related to this patient are: 3004721439-2018-00279, 3004721439-2018-00280.

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 that the shunt assistant valve has a blockage.This a fixed pressure valve.An adjustment test is not applicable.This is a fixed pressure valve.A braking force and brake function test is not applicable.We performed a visual inspection of the shunt assistant valve.No deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability, and adjustability of the valve.The shunt assistant was shown to have a blockage.Finally, we have dismantled the valve.There was no visible deposits inside the shunt assistant.Based on our investigation, we confirm that the shunt assistant is occluded.Even through no visible deposits were observed, it is possible that even a small amount of non-visible blood or protein can lead to temporary blockage and could be responsible for the suspected malfunction.We can exclude a defect at the time of release.The valve met all specifications of the final inspections.

• Brand Name: PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8112436
• MDR Text Key: 128656689
• Report Number: 3004721439-2018-00281
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• 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: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2023
• Device Model Number: FX435T
• Device Catalogue Number: FX435T
• Device Lot Number: 20039107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Distributor Facility Aware Date: 12/04/2018
• Device Age: 2 MO
• Date Manufacturer Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 27