MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMH & CO. KG SHUNTASSISTANT 2.0 20; HYDROCEPHALUS MANAGEMENT

Model Number	FX102T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a shuntassistant 2.0 20 (part # fx102t) was implanted during a primary procedure performed on on unknown date.According to the complainant, the patient underwent a revision procedure on (b)(6) 2022 to explant a shunt assistant along with another manufacturer's valve.Reportedly, when the new shunt assistant (part # fv251t) (ref.Mdr id 3004721439-2022-00138) was hooked up to a manometer, the valve did not appear to work with the manometer.Reportedly, it did not shut off when in the upright position.The device was removed and replaced to complete the procedure.The explanted valve was accidentally disposed of by the hospital coordinator.No patient complications were reported as a result of the revision procedure.A five (5) minute delay was reported as a result of the event.It is the same patient as mdr id # 3004721439-2022-00138.
Additional Manufacturer Narrative
Manufacturing and quality control data: because the serial or lot number of the device is unknown we are not able to trace production and quality control data.We confirm all parameters have been inspected and approved during the manufacturing.We assure that production and quality control ensure that only products conform to specifications are made available on the market.Conclusion information: an investigation was not possible because the product is not available.With reference to the reason for the complaint, we would like to point out that deposits inside the valve could be affected the functional impairment.Due to missing information (patient data, serial number, device itself), we are unable to provide a meaningful analysis.

• Brand Name: SHUNTASSISTANT 2.0 20
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMH & CO. KG; ulanenweg 2; potsdam 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIEHTKE GMBH & CO. KG; ulanenweg 2; potsdam 14469 ; GM 14469
• Manufacturer Contact: jörg knebel ; ulanenweg 2; potsdam 14469 ; GM 14469
• MDR Report Key: 14519562
• Report Number: 3004721439-2022-00137
• Device Sequence Number: 17514777
• Product Code: JXG
• UDI-Device Identifier: 04041906501587
• UDI-Public: 4041906501587
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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 Model Number: FX102T
• Device Catalogue Number: FX102T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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