MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SHUNTASSISTANT 2.0 25; HYDROCEPHALUS MANAGEMENT

Model Number	FX103T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	04/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to miethke that a shuntassistant 2.0 25 (part # fx103t) and a progav 2.0 valve (part # fx410t) (ref.Mdr id 3004721439-2021-00127) were implanted during a procedure performed on (b)(6) 2021.According to the complainant, the valve was believed to be operating in underdrainage.The patient underwent a revision procedure on (b)(6) 2021.The complaint devices were returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Implantation: (b)(6) 2021.Explantation: (b)(6) 2021.Age: (b)(6) months.Weight: (b)(6) kilograms (kg).Gender: male.The same event: medwatch # 3004721439-2021-00127.
Event or Problem Description
The same event: medwatch # 3004721439-2021-00127.
Additional Manufacturer Narrative
Investigation: visual inspection: no significant deformations or damage of the shuntassistant 2.0 were detected during the visual inspection.But there were found deposits in the inlet and outlet spout.A bactiseal catheter a third-party product was used.Permeability test: a permeability test has indicated that the shuntassistant 2.0 has a blockage.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.Because the shuntassistant 2.0 is not permeable, a computer controlled test is not possible.Results: first, we performed a visual inspection of the shuntassistant 2.0.No significant deformations or damage of the valve were detected during the visual inspection.Next, we tested the permeability.The shuntassistant 2.0 was not permeable and because of that, a computer controlled test is not possible.Finally, we have dismantled the valve.Inside the shuntassistant 2.0 we have found a build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve at the time of our investigation.We suspect that the deposits found inside the valve have led to the functional impairment.As described in scientific literature, deposits caused by natural substances present in the liquor, such as protein, blood or tissue particles, are among the known and 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 regulatory actions are required from our point of view.

• Brand Name: SHUNTASSISTANT 2.0 25
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11845469
• Report Number: 3004721439-2021-00128
• Device Sequence Number: 4503806
• Product Code: JXG
• UDI-Device Identifier: 04041906501594
• UDI-Public: 4041906501594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 09/02/2025
• Device Model Number: FX103T
• Device Catalogue Number: FX103T
• Device Lot Number: 20049516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: 6