MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG CONNECTOR STRAIGHT; HYDROCEPHALUS MANAGEMENT

Model Number	FV012T
Medical Device Problem Codes	Infusion or Flow Problem (2964); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.Should relevant additional information/investigation results become available, an additional medwatch report will be submitted.
Event or Problem Description
It was reported that a connector straight (#fv012t) was implanted during a procedure performed on (b)(6) 2024.According to the complainant, the product showed an under-drainage.The patient underwent a revision procedure performed on (b)(6) 2024.The complainant device has not yet returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Age: 74 years.Weight: 60 kgs.Height: 150 cm.Gender: female.Same event as # 3004721439-2024-00309.
Additional Manufacturer Narrative
Manufacturing site evaluation: no product received to date.We closed the case with a statement.

• Brand Name: CONNECTOR STRAIGHT
• 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: 20422261
• Report Number: 3004721439-2024-00310
• Device Sequence Number: 7627128
• Product Code: JXG
• UDI-Device Identifier: 04041906118204
• UDI-Public: 4041906118204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• 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): 10/28/2024

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
• Device Model Number: FV012T
• Device Catalogue Number: FV012T
• Device Lot Number: 20075244
• 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: 09/17/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 60 KG