MAUDE Adverse Event Report: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number	FV435T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/13/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to miethke that a progav sys w/sa 25 a.Control reservoir (part # fv435t) was implanted during a procedure performed in (b)(6) 2017.According to the complainant, the valve was not able to be adjusted.The patient underwent a revision procedure on (b)(6) 2017.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) years, weight: (b)(6) kilograms (kg), height: 170 centimeters (cm), gender: unknown.
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Manufacturing site evaluation: manufacturing and quality control data: the progav® was manufactured by a qualified employee in october 2016.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav® has a normal pressure range of 0 to 20 cmh2o.The shunt system was inspected as article fv435t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.Device examination: the progav® was returned submersed in an unidentified liquid in the provided returnkit.Visual inspection: a deformation of the outer housing of the progav valve was observed through the visual inspection.This was confirmed through a measurement of the plane parallelism.Additionally, the progav housing was measured which confirmed the presence of a deformation.Permeability test: a permeability test has shown that the valve was permeable, however, bloody fluid leaked from the valve.Adjustment test: the progav® was tested and was adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function operated as expected and the braking force required was within the given specification.Result: first, a visual inspection of the progav®.A deformation of the outer housing of the progav valve was observed through the visual inspection.Next, the permeability, adjustability, as well as the brake functionally and brake force, of the valve were tested.The valve operated as expected and met all specifications.Finally, the valve was dismantled.There were no visible deposits observed inside the valve.Based on the investigation, the claim of a device dysfunction was not able to be substantiated.The valve was found to be fully functional.Manufacturing defects at the time of release have been excluded.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.No further regulatory actions are required.

• Brand Name: PROGAV SYS W/SA 25 A.CONTROL RESERVOIR
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• MDR Report Key: 12746504
• Report Number: 3004721439-2021-00739
• Device Sequence Number: 19953451
• Product Code: JXG
• UDI-Device Identifier: 04041906132477
• UDI-Public: 4041906132477
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/03/2021

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: 09/29/2021
• Device Model Number: FV435T
• Device Catalogue Number: FV435T
• Device Lot Number: 20032039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2016
• 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: 32 YR
• Patient Weight: 70