MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV WITH SHUNTASSISTANT 25; HYDROCEPHALUS MANAGEMENT

Model Number FV414T

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

Patient Problem Hydrocephalus (3272)

Event Date 03/22/2024

Event Type  Injury  

Event Description

It was reported that a progav shuntsystem 25 (#fv414t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the shunt system was blocked 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.Patient information: age: 2 years 7 months, weight: 13 kg, height: 90 cm, gender: female.

Manufacturer Narrative

Visual inspection: during the investigation, a deformation of the outer housing of the progav could be determined.The measurement of the plane parallelism could confirm that with a value of -0,07 mm - outside tolerance (0 ± 0.02 mm).Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: to investigate the claim of over-drainage, the opening pressure is measured using a miethke computer controlled 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 progav does not operate within the accepted tolerance in the horizontal position.An accelerated outflow of progav could be determined.The test bench measurement for the shuntassistant could not be carried out completely because the valve had become blocked in the meantime.Adjustment test: the progav 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 cannot be measured due to the non-adjustability of the valve.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 adjustment difficulties for the progav.Initially, the entire system was permeable, but in the course of the investigation the shuntassistant got clogged.The determined deposits can be named as the cause for the accelerated outflow and the blockage.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.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 WITH SHUNTASSISTANT 25
• 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: 19127974
• MDR Text Key: 340414830
• Report Number: 3004721439-2024-00097
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906132118
• UDI-Public: 4041906132118
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103003
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV414T
• Device Catalogue Number: FV414T
• Device Lot Number: 20070911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 13 KG