MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV W/SHUNTASSIST.25 + DIST.CATH.; HYDROCEPHALUS MANAGEMENT

Model Number	FV421T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: (description incoming product condition): the product was received in the returnkit container with an unknown liquid.Result: first we performed a visual inspection of the progav.A deformation of the outer housing of the valve was observed.This deformation was confirmed through a measurement of the plane parallelism.No deformations could be detected during the visual inspection of the shuntassistant.Next we tested the permeability, adjustability, as well as the brake functionality and brake force.Both valves operated as expected and met all specifications.Based on our investigation, we cannot confirm the suspicion of occlusion; but it does not rule out the possibility that flushed out deposits may have temporarily affected the valve in the past.Finally we have dismantled the valves.Inside the valves we found no deposits.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a progav was blocked postoperatively.The valve was implanted on (b)(6) 2015.It was removed on (b)(6) 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.

• Brand Name: PROGAV W/SHUNTASSIST.25 + DIST.CATH.
• 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: 13020725
• Report Number: 3004721439-2021-00834
• Device Sequence Number: 4741854
• Product Code: JXG
• UDI-Device Identifier: 04041906132187
• UDI-Public: 4041906132187
• 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 Implanted Year: 2015
• 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): 12/15/2021

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: 06/30/2019
• Device Model Number: FV421T
• Device Catalogue Number: FV421T
• Device Lot Number: 20024836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2014
• 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: 59 YR
• Patient Sex: Unknown
• Patient Weight: 78 KG