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

Model Number	FV046T
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	08/20/2024
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
Limited information, no patient data available, product not yet at the manufacturer, suspected pre-operative complaint: when the ventricular catheter was cut with a cooper, a longitudinal crack was observed in the catheter.Another product was used.
Event or Problem Description
The device (part of #(b)(6) - ventricular catheter) was returned to the manufacturer for examination.
Additional Manufacturer Narrative
Investigation: visual inspection revealed that there were cut and tear marks on both parts of the ventricular catheter.They tend to be rough and uneven.The aforementioned longitudinal tear is also visible in the area of the tear marks.Based on the visual inspection, cut and tear marks were found on both parts of the ventricular catheter.The aforementioned longitudinal tear is visible in the area of the tear marks.At the time of return, the product is not in the original condition when it was shipped.Therefore, we are unable to explain how this damage occurred.The visual check during assembly and the final quality checks allow us to rule out a defect before shipment.No further actions are required as a result of the complaint.

• 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: 20225140
• Report Number: 3004721439-2024-00281
• Device Sequence Number: 12572723
• 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
• 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): 09/30/2024

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: 20073217
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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 Sex: Unknown