MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV WITH DISTAL CATHETER 9/19; HYDROCEPHALUS MANAGEMENT

Model Number	FV273T
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/15/2016
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 in the return kit.The valve was inserted in an unknown liquid.Visual inspection: no significant deformations or other abnormalities of the valve were detected during the inspection.Results: first, we performed a visual inspection of the paedigav.No significant deformation or damage of the valve were detected during the visual inspection.Next, we tested the permeability.The valve was shown to have a blockage.Finally, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, likely due to the deposits observed.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 the final inspection when released from christoph miethke gmbh & co.Kg.No further actions required.
Event or Problem Description
According to the complainant a paedigav with distal catheter had a malfunction postoperatively.The patient was originally implanted on (b)(6) 2016.The valve was suspected to be blocked, and was removed/revised 24 days later.Further details were not provided.

• Brand Name: PAEDIGAV WITH DISTAL CATHETER 9/19
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12379084
• Report Number: 3004721439-2021-00609
• Device Sequence Number: 19814555
• Product Code: JXG
• UDI-Device Identifier: 04041906114909
• UDI-Public: 4041906114909
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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: 12/31/2019
• Device Model Number: FV273T
• Device Catalogue Number: FV273T
• Device Lot Number: 20025497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2016
• Initial Report FDA Received Date: 08/27/2021
• 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: 4 MO
• Patient Weight: 2