MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number FX643T

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hydrocephalus (3272)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a progav 2.0 shuntsystem (part # fx643t) was implanted during a procedure performed in on (b)(6) 2021.According to the complainant, the shunt system was believed to be operating in under-drainage.The patient underwent a revision procedure on (b)(6) 2021.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: (b)(6).Height: 80 centimeters (cm).Weight: (b)(6) kilograms (kg).Gender: female.

Manufacturer Narrative

Investigation: visual inspection: the following observations were made during the visual inspection: -some particles in the delivery liquid.Permeability test: the test showed that both valves are permeable.Some deposits were flushed out during the test.Computer control test: the computer controlled test showed the opening pressure of the progav 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0.49 cmh2o.This is within the specified tolerance of 0 cmh2o ± 3 cmh2o.Additionally, the shuntassistant 2.0 was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 25 cmh2o in the vertical position, a pressure of 25 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant 2.0 had a pressure of 21.42 cmh2o.This is not within the specified tolerance of 25 cmh2o +4/-2 cmh2o.According to our results, we can detect a presence of an accelerated outflow of the shuntassistant 2.0.Adjustability test: the progav 2.0 was found to be adjustable to all pressure settings.The shuntassistant 2.0 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 shunt system.After dismantling of the valves, some deposits were found in both valves.Results: based on our investigation results, we can identify a accelerated outflow in the shunt system.We are assuming that the deposits detected within the valves 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.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.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 2.0 WITH SHUNTASSISTANT 2.0 25
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12537664
• MDR Text Key: 273772507
• Report Number: 3004721439-2021-00277
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 04041906502010
• UDI-Public: 4041906502010
• Combination Product (y/n): N
• PMA/PMN Number: K190174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX643T
• Device Catalogue Number: FX643T
• Device Lot Number: 20050798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 10