MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX440T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/06/2020

Event Type  Injury  

Manufacturer Narrative

Additional information is transmitted in a follow-up report after the investigation.

Event Description

It was reported that there was a problem with a katheter from progav shuntsystem.Product was implanted in 2019.In (b)(6) 2020, the patient continued to be comatose and was hospitalized for reexamination.On (b)(6), an intraoperative exploration was carried out.During the exploration, no fluid flowed out of the abdominal cavity.The diagnosis was that the shunt pipe was blocked.Additional information about the patient are not available.

Event Description

Additional patient information: age: 2 years, height: 83 cm, weight: 12 kg.Implanation: (b)(6) 2019.Removal: (b)(6) 2020.

Manufacturer Narrative

Investigation results: visual inspection: small hole in the catheter between the prechamber and the progav 2.0.Permeability test: the test showed that the progav 2.0 shunt system is permeable.During the test was flushed out a piece of deposit.The test showed that the ventricular catheter is permeable.Computer controlled test: the computer controlled test has shown the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/hr in a horizontal position, to be 5.96 cmh2o.This is not within the specified tolerance of 11 cmh2o ± 3 cmh2o.An applied pressure of 11 cmh2o, with the device in the horizontal position is expected to have a resultant opening pressure of 11 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can detect a presence of an over-drainage.Additionally, the shuntassistant was tested according to standard procedure in the horizontal and vertical position.At a fixed opening pressure of 15 cmh2o in the horizontal position, a pressure of 2 cmh2o ± 2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/hr in the horizontal position, the shuntassistant® had a pressure of 1.27 cmh2o.This is within the specified tolerance of 2 cmh2o ± 2 cmh2o.The test, performed in the vertical position at a reference flow of 20 ml/hr, has shown that the shuntassistant with a result of 14.26 cmh2o is operating within the specified tolerance (between 13 cmh2o and 19 cmh2o).Adjustability test: 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: -the braking force of the progav 2.0 was within the specified tolerance and the brake function operated as expected.Internal inspection of product: after dismantling of the valves, clearly deposits were found in both valves.Results: based on our investigation, we are not able to substantiate the claim of "blockage".However, we assume that the significant deposits found within the valves may have temporarily 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.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV SYS PED.W/SA 15 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10239354
• MDR Text Key: 197949257
• Report Number: 3004721439-2020-00135
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 08/21/2020

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: 11/14/2022
• Device Model Number: FX440T
• Device Catalogue Number: FX440T
• Device Lot Number: 20035838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 12