MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PAED.M.SA20 U.VORKAMMER; HYDROCEPHALUS MANAGEMENT

Model Number FX441T

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

Patient Problem Hydrocephalus (3272)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

The product for investigation has not yet reached us.When additional informations are provided, a follow up will be submitted.

Event Description

It was reported that there was a problem with a progav 2.0 valve.Initial surgery placed progav on (b)(6) 2017.(b)(6) 2020, it was confirmed that the pressure could not be changed.(b)(6) 2020, the product was extracted due to suspected valve blockage.No further information available.

Manufacturer Narrative

Visual inspection: in the first step of our investigation, we performed a visual inspection of the product.We have checked for possible damages, deformations of the housing or other abnormalities.The following observations were made during the visual inspection: a deep scratch on the housing of the progav 2.0 and holes in the membrane of the prechamber.Permeability test: to check if the progav® 2.0 shunt system is blocked, we have performed a permeability test on the shunt system.This test is carried out with the product in the horizontal position with a hydrostatic pressure difference of approx.30 cmh2o in the direction of flow.The test showed that the progav® 2.0 shunt system is non-permeable.To determine the location of the occlusion, the shunt system was dismantled and each element was tested individually for permeability.The test showed that the progav® 2.0 is non-permeable, while the shuntassistant® is difficult permeable and the is prechamber permeable.Adjustability test: we have investigated whether the progav 2.0 can be successfully set to each specified pressure setting.Thus, indicating whether the valve(s) are fully adjustable within the full range of specified pressure settings ( in increments of 5 cmh2o).The progav® 2.0 was found to be not fully adjustable to specifications.Braking force and brake function test: the braking force and brake function test investigates whether the braking function of the adjustable valve(s) is present and how much force must be exerted on the housing to release the rotor to adjust the valve(s) using the integrated magnet of a specific measurement apparatus of braking force.The braking force test indicates that the brake function of the progav 2.0® valve is present.Due to the non-adjustability of the valve, as detailed in section 7.5, an investigation of the braking force was not possible.Internal inspection of product: in order to verify whether the investigated shunt system was compromised by the known risks of hydrocephalus therapy, e.G.By a build-up of natural substances (protein, blood, or tissue particles) in the cerebrospinal fluid, we have dismantled the shunt system.After dismantling of the valves, some deposits were found in both valves and the prechamber.Results: based on our investigation, we are able to substantiate the claim of "non- adjustability" and "blockage".We are assuming that the deposits detected within the valve have caused the functional impairment.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of 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.

Event Description

Patient information: age: 5 years; weight: 9,27 kg; height: 83,2 cm; gender: not known.Investigation is completed the result will be submitted with this follow up report.

• Brand Name: PROGAV 2.0 SYS PAED.M.SA20 U.VORKAMMER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; ulanenweg 2; potsdam, 14469 ; GM
• MDR Report Key: 11089827
• MDR Text Key: 229839163
• Report Number: 3004721439-2020-00268
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137465
• UDI-Public: 4041906137465
• Combination Product (y/n): N
• PMA/PMN Number: K161853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

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: 09/22/2021
• Device Model Number: FX441T
• Device Catalogue Number: FX441T
• Device Lot Number: 20032159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 5 YR
• Patient Weight: 9