MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA25 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX421T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/05/2017
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 shunt system.No significant deformations or damge of the valves were detected.Next we tested the permeability, adjustability, and opening pressures, as well as the brake functionality and brake force.Both valves operated as expected and met all specifications.No noise development could be perceived with either component.Finally we have dismantled the valves.Inside the progav we found a small amount of build-up of substances.Inside the shuntassistant were no visible deposits.In very rare cases, noises may occur in the valves when the base frequency is reached.However, this occurrence is only possible in very specific circumstances, but it does not affect the function of valve.More information can be found in literature, "flow-related noise in patient with ventriculoperitoneal shunt using gravitational adjustable valves".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 made noises postoperatively.The valve was implanted in (b)(6) 2017.It was removed on (b)(6) 2017 due to the malfunction and returned to the manufacturer.Further details were not provided.

• Brand Name: PROGAV 2.0 WITH SA25 AND DISTAL CATHETER
• 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: 13020736
• Report Number: 3004721439-2021-00839
• Device Sequence Number: 4803214
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2021

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: 12/31/2020
• Device Model Number: FX421T
• Device Catalogue Number: FX421T
• Device Lot Number: 20029707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• 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: 03/21/2016
• 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 Sex: Unknown