MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX448T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	06/26/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the complainant a progav was not adjustable postoperatively.The patient was originally implanted on (b)(6) 2016.The valve was explanted on (b)(6) 2017 and returned to the manufacturer for evaluation.Further details were not provided.Height: 69 cm.
Additional Manufacturer Narrative
This complaint was reopened in reference to qab (b)(4).Investigation: ( description incoming product condition) the valve was received submersed in an unidentified liquid in the provided return kit.Result: first we performed a visual inspection of the progav.No significant 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 valve was not permeable, but met other specifications.Finally, we have dismantled the valve.Inside the valve we have found a small amount of build-up substances (likely protein).Based on our investigation, we are unable to substantiate the claim of non-adjustability.At the time of our investigation, the valve was able to be adjusted to all specified settings.However it is possible that the deposits observed inside the valve could have caused the malfunction in the past.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 shunt system met all specifications of the final inspection when released from christoph miethke (b)(4).No further actions required.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• 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: 12892819
• Report Number: 3004721439-2021-00761
• Device Sequence Number: 1491895
• Product Code: JXG
• UDI-Device Identifier: 04041906137748
• UDI-Public: 4041906137748
• 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 Implanted Year: 2016
• 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): 11/30/2021

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: FX448T
• Device Catalogue Number: FX448T
• Device Lot Number: 20029826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2016
• 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
• Patient Weight: 8 KG