MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PAEDIGAV SYSTEM W.PRECHAMBER 4/24; HYDROCEPHALUS MANAGEMENT

Model Number	FV284T
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
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 during insertion of the catheter into the introducer canal, the catheter detaches from the valve (#fv284t).The complainant device will returned to the manufacturer for evaluation.No patient complications were reported.
Additional Manufacturer Narrative
Manufacturing and quality control data: due to the limited information and the missing product investigation is restricted to traceability of manufacturing and quality control data.The paedigav was manufactured by a qualified employee in december 2021.Deviations during assembly did not occur.The product was finally tested as article fv284t and released for packaging and sterilization and was sterilized by miethke.The parameters after completion of the valve assembly were tested at the fixed pressures of 4 cmh2o in the horizontal and 24 cmh2o in the vertical position and were found to meet specifications.All tested parameters were assessed according to specifications.Conclusion information : an investigation was not possible as no product was sent in for examination.Based on the form of our final quality control and the performance of the passed tension test prior to sterilization and shipment, we can exclude the presence of a defect at the time of delivery of the paedigav.During the final quality control, the product met all specifications.If a product fails the tension test, it will be discarded and not released for packaging and sterilisation.Unfortunately, we cannot provide a meaningful analysis due to the missing sample.
Event or Problem Description
No sample returned for analysis.The case is closed with the recording of the production data.
Additional Manufacturer Narrative
Investigation: visual inspection: during the investigation, disconnected catheter visible at the end of the valve and a dispositioned kink protection were determined.Summary of the investigation results: during the investigation, we can determine that the visible separation line is tapered.How the abovementioned occurrence is not clear to us at the time of examination.Based on additional testings of catheter rupture, a vertical separation line could be detected, see the following picture.Prior all shipments of products with catheters a tension test is performed, which was documented in a final documentation.The returned product passed a successfully test.So, it could be exclude a presence of a defect at the time of delivery, since the final documentation proves a successfully completed test.No further actions are required as a result of the complaint.
Event or Problem Description
The sample was returned for evaluation to the manufacturer on (b)(6) 2023.

• Brand Name: PAEDIGAV SYSTEM W.PRECHAMBER 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: 17357602
• Report Number: 3004721439-2023-00194
• Device Sequence Number: 6543888
• Product Code: JXG
• UDI-Device Identifier: 04041906116002
• UDI-Public: 4041906116002
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K011030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2023

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 Model Number: FV284T
• Device Catalogue Number: FV284T
• Device Lot Number: 20056512
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 09/28/2023; 11/14/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 10/10/2023; 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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
• Patient Sex: Unknown