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	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reopened in reference to (b)(4).Investigation: ( description incoming product condition) we received the valve submersed in an unidentified liquid within a plastic container.Summary: first, we performed a visual inspection of the valve.No significat deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability, adjustability as well as the brake functionality and brake force.The opening pressure of the valve was out of tolerance, but all other specifications were met.The first measurement has shown that the valve was working outside the tolerance.The measurement could confirm under-drainage.The computer test of the shuntassistant has shown that the valve is outside the tolerance, and in contrast to the valve, over-drainage was diagnosed.Finally, we dismantled the valve.Inside both valves we have found slight build-up of substances (likely protein).Based on our investigation results we can confirm the suspected under-drainage of the valve.This is likely due to the deposits observed inside the valves.As described in scientific literature, the problem encountered is one of the known, inevitable risks of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of he final inspection when released from christoph miethke (b)(4).No further actions required.
Event or Problem Description
According to the complainant a progav was suspected of underdrainage postoperatively.The patient was originally implanted on an unspecified date.Tlhe valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.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
• MDR Report Key: 12656510
• Report Number: 3004721439-2021-00700
• Device Sequence Number: 4480845
• Product Code: JXG
• UDI-Device Identifier: 04041906136635
• UDI-Public: 4041906136635
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141687
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 02/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 10/19/2021
• 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: 10 MO