MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FX490T

Device Problem Mechanical Problem (1384)

Patient Problem Hydrocephalus (3272)

Event Date 04/11/2024

Event Type  Injury  

Event Description

It was reported to aesculap inc.That a progav 2.0 (#fx490t) was implanted during a procedure performed in 2010.According to the complainant according to the complainant, the shunt system has never been adjusted since it´s initial implant.When it was to be adjusted, it was not possible to change the valves settings.A revision has been scheduled for (b)(6) 2024.The complainant device will be returned to the manufacturer for evaluation.At the time of the creation of this submission, no patient complications were reported as a result of the revision procedure.The adverse event is filed under aic reference (b)(4).

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Investigation: visual inspection: during the investigation, no significant deformation or damage of the shuntsystem were determined.Permeability test: a permeability test has shown that all components are permeable.Computer controlled test: the opening pressure is measured by using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valves were tested in both the horizontal as well as the vertical positions.The results show that the valves operate within the permissible tolerance in their respective relevant positions.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.

• Brand Name: PROGAV 2.0 WITH PED.BURRHOLE RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 19118526
• MDR Text Key: 340299778
• Report Number: 2916714-2024-00074
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137786
• UDI-Public: 4041906137786
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX490T
• Device Catalogue Number: FX490T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2024
• Distributor Facility Aware Date: 03/27/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 68 KG