MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV441T
Medical Device Problem Codes	Break (1069); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a progav 2.0 (#fx410t) was implanted during a procedure performed on (b)(6) 2022 according to the complainant, the distal catheter ruptured spontaneously at the neck height.A part of the catheter drifted and got stuck in the abdominal cavity.The patient underwent a revision procedure.A new valve was placed.No patient complications were reported as a result of the revision procedure.Age: 12 years.Height: 156 centimeters (cm).Weight: 42 kilograms (kg).Gender: male.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deposits on the pediatric prechamber, deposits in the inlet catheter, ruptured distal catheter.Measurement of surface of the housing: deformation detected: yes - measured value: -0,05 mm [tolerance (0 ± 0.02mm)] too much pressure on the valve, for example through the adjustment tool or resulting from a fall or hit to the head of the patient, can compromise the integrity of the valve.Permeability test: the test showed that the progav shunt system is permeable.Additionally, we tested the pediatric prechamber.Out test determined that the prechamber is permeable.During the tests, some particles were flushed out.Computer control test: the computer controlled test showed the opening pressure of the progav, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 12.62 cmh2o.This is within the specified tolerance of 11 cmh2o ± 3 cmh2o.Additionally, the shuntassistant was tested according to standard procedure in the vertical position of the valve.At a fixed opening pressure of 20 cmh2o in the vertical position, a pressure of 20 cmh2o +4/-2 cmh2o is expected.The results indicated that at a reference flow of 20 ml/h in the vertical position, the shuntassistant® had a pressure of 19.21 cmh2o.This is within the specified tolerance of 20 cmh2o +4/-2 cmh2o.Adjustability test: the progav 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 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, the valves are finally opened with a special tool.After dismantling of the valves, deposits were found in both valves.Results: based on our investigation results, we can determine a deformation of the outer housing of progav, a rupture of the distal catheter and deposits in both valves.The deposits had no affect to the technical properties at the time of the investigation.The cause of the deformation and the aforementioned functional impairment is not known to us at the time of the examination.Proteins in the cerebrospinal fluid can influence the function temporarily and are known side effects in hydrocephalus therapy.It might be a result of growth that the catheter has been torn off.Nevertheless, it is retrospective not possible for us to determine the exact cause of the rupture.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 20 A.PRECHAMBER
• Common Device Name: 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: 15117004
• Report Number: 3004721439-2022-00220
• Device Sequence Number: 5498869
• Product Code: JXG
• UDI-Device Identifier: 04041906132545
• UDI-Public: 4041906132545
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: G52679C57043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male
• Patient Weight: 42 KG