MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS SA2.0 20 & CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number FX602T

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2019

Event Type  Injury  

Manufacturer Narrative

Height: 175cm.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported that valve is blocked.The reporter indicated that a 2 month 4 day post operative valve is blocked and required explantation.Additional information has not been provided.

Manufacturer Narrative

Investigation: visual inspection: no significant deformations or damage of the valves were detected during the visual inspection.Permeability test: a permeability test has shown that the valves are permeable adjustment test: the adjustment test has shown that the progav 2.0 is adjustable to all settings.For the shunt assistant 2.0 the adjustment test is not applicable, because it is a valve with a fixed pressure.Braking force and brake function test: the investigation of the braking force of the progav 2.0 valve showed that the brake function is fully operational and the braking force is within the given tolerances.For the shunt assistant 2.0 the test is not applicable, because it is a valve with a fixed pressure.Results: first, we performed a visual inspection of the valves.No significant deformations or damages of the valves were detected during the visual inspection.Further, we tested the permeability of the valves.The test has shown that the valves were permeable.The testing of the adjustability, the brake functionality and as well the brake force of the progav 2.0 valve was possible and within the accepted tolerances.For the shunt assistant 2.0 the test is not applicable because it is a valve with a fixed pressure.Finally, we have dismantled the valves.There were no visible deposits observed inside the valves.We cannot confirm the suspected blockage.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.Further actions: no further actions are required in our point of view.

• Brand Name: PROGAV 2.0 SYS SA2.0 20 & CONTROL RES.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9583730
• MDR Text Key: 188559382
• Report Number: 3004721439-2020-00007
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

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: 07/16/2024
• Device Model Number: FX602T
• Device Catalogue Number: FX602T
• Device Lot Number: 20043053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80