MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PRECHAMBER PED.; HYDROCEPHALUS MANAGEMENT

Model Number	FV035T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	02/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation on-going.Investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that a progav 2.0 shunt system (part # fv035t) was implanted in (b)(6) 2020.According to the complainant, the shunt system was believed to be clogged.The patient underwent a revision procedure.The complaint device was returned for evaluation.No patient complications were reported as a result of the revision procedure on (b)(6) 2021.Patient informations: age y: (b)(6) month.Height cm: (b)(6).Weight kg: (b)(6).Same patient/event: medwatch#3004721439-2021-00064.
Event or Problem Description
Same patient/event: medwatch#3004721439-2021-00064.3.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: signs of mold in the pediatric prechamber.No defects.Permeability test: the test showed that the pediatric prechamber is permeable.Results: based on our investigation results, we cannot identify a "blockage" of the prechamber.At the time of the investigation, it was not clear to us how the mentioned functional impairment occurred.No functional deviations were detected.Deposits caused by natural substances in the cerebrospinal fluid, such as protein, blood or tissue particles, are among the known and unavoidable risks and side effects of hydrocephalus therapy.Small amounts of non-visible deposits/proteins might compromise the integrity of the valve.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: PRECHAMBER PED.
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11627494
• Report Number: 3004721439-2021-00065
• Device Sequence Number: 17060796
• Product Code: JXG
• UDI-Device Identifier: 04041906117603
• UDI-Public: 4041906117603
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2021

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: 06/04/2025
• Device Model Number: FV035T
• Device Catalogue Number: FV035T
• Device Lot Number: 20048163
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/02/2021
• 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: 3 MO
• Patient Weight: 4