MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS SA2.0 15 & CONTROL RES.; HYDROCEPHALUS MANAGEMENT

Model Number FX550T

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

Patient Problem Hydrocephalus (3272)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.

Event Description

It was reported that a progav 2.0 (#fxxxxt) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the valve showed an over-drainage and adjustment problems.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: unknown weight: unknown height: unknown gender: unknown.

Event Description

It was reported that a progav 2.0 (#fx550t) was implanted during a procedure performed on (b)(6) 2023.According to the complainant, the valve showed an over-drainage and adjustment problems.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 34 years, 6 months.Weight: 87 kg.Height: 170 cm.Gender: female.

Manufacturer Narrative

Visual inspection: during the investigation, no significant deformations or damage of the valves was determined.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 valve is tested in the horizontal position.The results show that the valve operates within the accepted tolerances in the horizontal position.Adjustment test: the progav 2.0 was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Internal inspection: after dismantling of the valve, no deposits were found in progav 2.0.To make the deposits in the valve more visible, they were colored using a staining solution.Result: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.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.No further regulatory actions are required from our point of view.

• Brand Name: PROGAV 2.0 SYS SA2.0 15 & CONTROL RES.
• 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: 18939504
• MDR Text Key: 338079219
• Report Number: 3004721439-2024-00063
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906503154
• UDI-Public: 4041906503154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: FX550T
• Device Catalogue Number: FX550T
• Device Lot Number: 20070966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2023
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 87 KG