MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV SYSTEM PED.WITH PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FV438T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to miethke that a progav shuntsystem (part # fv438t) was implanted during a procedure performed on an unknown date.According to the complainant, the device was believed to be operating in over-drainage and had a problem with adjustability.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: 93 centimeters (cm) weight: (b)(6) gender: male.
Event or Problem Description
Investigation is completed.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav® was manufactured by a qualified employee on august 2021.Deviations during assembly did not occur.The product was finally tested as article fv438t and released for packaging and sterilization and was sterilized by miethke.The progav® has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.Visual inspection: the following observations were made during the visual inspection: - deposits on the reservoir.Permeability test: the test showed that the progav® is permeable, the liquid was bloody.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 1,34 cmh2o.This is not within the specified tolerance of 13 cmh2o ± 3 cmh2o.An applied pressure of 13 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 13 cmh2o ± 3 cmh2o.Additional testing did not significantly change the results.According to our results, we can confirm the presence of a accelerated outflow.Adjustability test: the progav® was found to be adjustable to all pressure settings.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: after dismantling of the valve, clearly deposits were found in progav®.Results: based on our investigation results, we can identify a accelerated outflow in the valve 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.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 valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYSTEM PED.WITH PRECHAMBER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12189646
• Report Number: 3004721439-2021-00201
• Device Sequence Number: 11522224
• Product Code: JXG
• UDI-Device Identifier: 04041906132514
• UDI-Public: 4041906132514
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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 Expiration Date: 06/12/2022
• Device Model Number: FV438T
• Device Catalogue Number: FV438T
• Device Lot Number: 20034194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 MO
• Patient Weight: 19