MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV WITH DISTAL CATHETER 4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV272T
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/18/2022
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 paedigav (part # fv272t) was implanted during a procedure performed on an unknown date.According to the complainant, a calcified catheter was observed.The patient underwent a revision procedure.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.
Event or Problem Description
No further information.No sample available for investigation.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product, the traceability of manufacturing and quality control data could not be performed.We ensure that our manufacturing and quality control system guarantee that only products conforming to the specifications in the final quality checks are released to the market.Conclusion information: an investigation was not possible because the product is not available.Due to missing information (patient data, serial number, device itself), we are unable to provide a meaningful analysis.

• Brand Name: PAEDIGAV WITH DISTAL CATHETER 4/24
• 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: 15440815
• Report Number: 3004721439-2022-00285
• Device Sequence Number: 5672865
• Product Code: JXG
• UDI-Device Identifier: 04041906114800
• UDI-Public: 4041906114800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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: FV272T
• Device Catalogue Number: FV272T
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown