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 Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition).The valve was received submersed in an unindented liquid via the provided returnkit.Result: first we performed a visual inspection of the valve.A significant deformation of the outer housing was observed.The deformation was confirmed through a measurement of the plane parallelism.Significant outside pressure, for example by too much force from the adjustment tool, or by a fall or impact to the head of the patient, can compromise the integrity of the valve.Next we tested the permeability, adjustability, as well as the brake functionality and braking force.The valve was not permeable and not adjustable to any pressure levels.It was not possible to test the brake function and measure the braking force.A deformation can cause the lowering of the housing diaphragm, which due to the preload set, generates the braking force, which is supposed to hold the rotor in its position.As a result of the deformation this is no longer the case.The brake is defective.Next, we have dismantled the valve.There were no deposits observed inside.Based on our investigation, we can confirm that the valve was non-adjustable at the time of our investigation.The cause of the deformation of the valve and the resultant defect of the rotor could not be determined through our investigation.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miehtke gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a progav was not adjustable postoperatively.The valve was implanted on (b)(6) 2014.The valve was explanted on (b)(6) 2017 and returned to the manufacturer.Further details were not provided.Height: 105 cm.

• 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: 12989581
• Report Number: 3004721439-2021-00821
• Device Sequence Number: 5014534
• Product Code: JXG
• UDI-Device Identifier: 04041906132545
• UDI-Public: 4041906132545
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/13/2021

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: 06/30/2018
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 20021788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2017
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2013
• 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: 5 YR
• Patient Sex: Unknown
• Patient Weight: 17 KG