MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX441

Device Problems Complete Blockage (1094); Increase in Pressure (1491)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

Opening pressure upon intake.At the time of intake, the progav® 2.0 showed a pressure setting of 7 cmh2o.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: apart from slight scratches on the housing of progav® 2.0 no significant deformations or damage of the valve was detected during the visual inspection.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 permeable.Computer controlled test: in order to investigate the suspicion of underdrainage, the progav® 2.0 shunt system was tested on a miethke computer controlled testing apparatus.The shunt system was tested by simulating a cerebrospinal fluid flow at rates from 60 ml/hr down to 5 ml/hr with the valve in horizontal and vertical position (in accordance with iso 7197).Distilled water was used as the test liquid.The resulting opening pressure was measured.The computer controlled test has shown the opening pressure of the progav® 2.0 shunt system, at a reference flow rate of 20 ml/hr in a horizontal position, to be 21.29 cmh2o.This is not within the specified tolerance of 7 cmh2o ± 3 cmh2o.An applied pressure of 7 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 4 cmh2o ± 10 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of an underdrainage.Additionally, the shuntassistant® was tested according to standard procedure in the horizontal and vertical position.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 18 cmh2o to 24 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the vertical position, the shuntassistant® had a pressure of 17.32 cmh2o.This is not within the specified tolerance of 18 cmh2o ± 24 cmh2o.Additional testing did not significantly change the results.According to our results, we found an overdrainage on the shuntassistant®.The test, performed in the horizontal position at a reference flow of 20 ml/hr, has shown that the shuntassistant®, with a result of 0.38 cmh2o is operating within the specified tolerance (0 cmh2o to 4 cmh2o).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 adjustable to all pressure settings.The shuntassistant® is a fixed pressure valve, therefore the adjustability test is inapplicable.Braking force and brake function test: a specific measurement device apparatus of braking force is used to investigate the braking force and the brake function of adjustable valves.This apparatus tests whether the braking function is present and how much force must be exerted on the housing to release the rotor to adjust the valve using the integrated magnet of the braking force apparatus.The braking force of the progav 2.0® was within the specified tolerance and the brake function operated as expected.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, clearly deposits were found in both valves.Results: based on our investigation, we are able to substantiate the claim of "under-drainage".However, we cannot confirm a blockage.The shunt system was permeable.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 valve / shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).

Event Description

It was reported that there was a problem with a progav 2.0 shunt system.The reporter suspected a blockage and underdrainage.Patient information: height: 70,4 centimeters (cm).Gender: unknown.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.PRECHAMBER
• 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: 10373884
• MDR Text Key: 202015640
• Report Number: 3004721439-2020-00150
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906137465
• UDI-Public: 4041906137465
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX441
• Device Catalogue Number: FX441
• Device Lot Number: 20043928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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: 7 MO
• Patient Weight: 10