MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG SPRUNG RESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FV046T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/02/2024
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 that a sprung reservoir-set (# fv046t) was implanted during a revision procedure (medwatch#3 004721439-2024-00120) performed on (b)(6) 2024.The sprung reservoir was implanted together with # fx418t (medwatch#3004721439-2024-00135).According to the complainant, the shunt system caused a blockage.The patient underwent an additional revision procedure.The complainant device will be returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 7 months height: 64 cm weight: 9 kg gender: male same incident/patient as medwatch# 3004721439-2024-00135.
Additional Manufacturer Narrative
Visual inspection: during the investigation, no significant deformations or damage of the reservoir was determined.Permeability test: a permeability test has shown that the reservoir is permeable.Results: based on our investigation results, we cannot determine functional deviations or other abnormalities in the product.How the abovementioned functional impairment occurred is not clear to us at the time of examination.We can exclude a defect at the time of release.The shunt system 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: SPRUNG RESERVOIR SET W/DISTAL CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 19405675
• Report Number: 3004721439-2024-00153
• Device Sequence Number: 20527314
• Product Code: JXG
• UDI-Device Identifier: 04041906131395
• UDI-Public: 4041906131395
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: FV046T
• Device Catalogue Number: FV046T
• Device Lot Number: 20064183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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 Age: 7 MO
• Patient Sex: Male
• Patient Weight: 9 KG