MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG VENTRICULAR CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX597T
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: some particles in the delivery liquid and on the catheter.The ventricular catheter has been shortened from length (original 250mm).Crack / cut marks in the end of the ventricular catheter.Permeability test: the permeability test was performed at a hydrostatic pressure difference of the pressure setting of the ventricular catheter upon receipt plus 30 cmh2o in the horizontal direction of flow.The test showed that the ventricular catheter is permeable.Results: based on our investigation results, we can identify cut marks and a shortened catheter.No further examination of the shunt system was performed, because no complaint was reported and it was still originally sterile packaged.At the time of the investigation, it was not clear to us how the mentioned functional impairment occurred.We can exclude a defect at the time of release.The ventricular catheter met all specifications of the final inspection when released from christoph miethke (b)(4).From our point of view, no further regulatory actions are required.
Event or Problem Description
It was reported that a ventricular catheter loose csf liquid, seems to be perforated before surgery.A delay of more than 15 minutes in surgery occurred.The ventricular catheter is a part of the lot 20049548 (fx597t) progav 2.0 shuntsystem ((b)(4)).No patient information were submitted.

• Brand Name: VENTRICULAR CATHETER
• Common Device Name: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 12657728
• Report Number: 3004721439-2021-00292
• Device Sequence Number: 19953419
• Product Code: JXG
• UDI-Device Identifier: 04041906120603
• UDI-Public: 4041906120603
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2025
• Device Model Number: FX597T
• Device Catalogue Number: FX597T
• Device Lot Number: 20049548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1