MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SPRUNG RESERVOIR-SET M.DISTALEM KATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV046T
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer 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 sprung reservoir (part # fv046t) was implanted during a procedure performed on (b)(6) 2021.According to the complainant, the sprung reservoir malfunctioned.The patient underwent a revision procedure on (b)(6) 2021.The complaint device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Patient informations: age: (b)(6) years; gender: female.Same patient/event: medwatch#3004721439-2021-00067.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: deposits within the reservoir.Permeability test: the test showed that the sprung reservoir is permeable.Results: based on our investigation results, we cannot identify a deviation of the function.However, we assume that the significant deposits found within the reservoir may have temporarily caused the functional impairment.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 valves or reservoirs.We can exclude a defect at the time of release.All products met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.This case is connected to 3004721439-2021-00067.

• Brand Name: SPRUNG RESERVOIR-SET M.DISTALEM KATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 11645019
• Report Number: 3004721439-2021-00074
• Device Sequence Number: 2982157
• Product Code: JXG
• UDI-Device Identifier: 04041906131395
• UDI-Public: 4041906131395
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110206
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: No Information
• Device Model Number: FV046T
• Device Catalogue Number: FV046T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 06/16/2021
• 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: 80 YR