MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 YS PED.W/SA15 A. PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX440-T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Additional information/ investigation results will be provided in a supplemental report.

Event Description

It was reported that there was a problem with a progav 2.0 shuntsytsem.This product was implanted in (b)(6) 2020.In (b)(6) 2020, the patient was admitted to the hospital for reexamination.During the operation, the doctor found that there was no fluid flowing out of the abdominal cavity.It was difficult to press the fluid reservoir and the shunt tube was blocked.The shunt tube has been removed from the patient.No further patient datas are available at this time.

Manufacturer Narrative

- updated information in b5 and section d - investigation result: visual inspection: the following observations were made during the visual inspection: -some particles in the delivery liquid, but no defects or other abnormalities are detected permeability test: 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 and the shuntassistant is permeable, while the distal peritoneal catheter is non-permeable.We could see a coloration of the catheter.During flushing the catheter, a yellowish substance flushed out, which might be the cause of the blockage.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: 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 valves.After dismantling of the valves, no deposits were found in both valves.Results: based on our investigation, we are able to substantiate the claim of "blockage".We are assuming that the deposits detected within the catheter 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.From our point of view, no further regulatory actions are required.

Event Description

The shuntsystem received on 12/22/2020.The investigation was completed on 01/06/2020.Additional informations: another lot number and production date is available.Patient informations: age: 3 years height: 87 cm weight: 12 kg date of implantation: (b)(6) 2020 date of removal: (b)(6) 2020.

• Brand Name: PROGAV 2.0 YS PED.W/SA15 A. PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10982903
• MDR Text Key: 220646733
• Report Number: 3004721439-2020-00249
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906140762
• UDI-Public: 4041906140762
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2022
• Device Model Number: FX440-T
• Device Catalogue Number: FX440-T
• Device Lot Number: 20035906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 12