MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 30; HYDROCEPHALUS MANAGEMENT

Model Number FX644T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Type  Injury  

Event Description

It was reported that a progav 2.0 shuntsystem (#fx644t) was implanted during a procedure.According to the complainant, the shunt system caused an overdrainage and had adjustment difficulties.The patient underwent a revision procedure.The complainant device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 14 years.Height: 155 centimeters.Weight: 50 kilograms.Gender: male.

Manufacturer Narrative

Investigation: visual inspection: during the investigation, scratches on the outer housing of the progav 2.0 shuntsystem, but no significant deformations or damage and deposits on the device was determined.The shuntassistant 2.0 showed no abnormalities.Permeability test: a permeability test has shown that all components are permeable.Computer control test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer control testing apparatus which simulates a cerebrospinal fluid flow.The valves are tested in both the horizontal as well as the vertical positions.The results show that the both valves are not operating within the acceptable tolerance in either position.An accelerated outflow could be determined in both valves.Adjustment test: the progav 2.0 was tested and is not adjustable.Braking force and brake function test: the brake functionality test has shown that the brake function operates as expected.However, the breaking force required was not within the given specifications.Internal inspection : after dismantling of the valves, deposits were found in both valves.Results : based on our investigation results, we can determine an accelerated outflow and a non- adjustability in the shunt system.The determined deposits can be named as the cause for the functional deviations.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 WITH SHUNTASSISTANT 2.0 30
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 18055559
• MDR Text Key: 327171220
• Report Number: 3004721439-2023-00319
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906502027
• UDI-Public: 4041906502027
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2023

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 Model Number: FX644T
• Device Catalogue Number: FX644T
• Device Lot Number: 20046502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG