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

Model Number	FV284T
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a paedigav shunt system (part # fv284t) was flushed before surgery.The valve had no drainage, even upon aspiration.No patient involvement.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: visual inspection: - dried deposits in the perforations of the ventricular catheter.- dried deposits in the distal end of the peritoneal catheter.- pediatric prechamber and paedigav not fixed connected with ligature.- traces of instruments/clamps on the kink protection catheter.Permeability test: we disconnected the shunt system at the non-fixed part and tested the two parts individually for permeability.The test showed that the ventricular catheter with the pediatric prechamber is permeable, whereas the paedigav with the peritoneal catheter is non-permeable.To determine the location of the occlusion, the paedigav with the peritoneal catheter was dismantled and each element was tested individually for permeability.The test showed that each part is permeable for itself.Additionally, after separating the different components of the shunt system, a deformation of the peritoneal catheter behind the valve was detected.Results: we would like to note in advance that the returned product was not submerged in liquid at the time of receipt.The testing of valves sent in in a dry condition is only of a limited value.Product performance may be affected by dry residues of cerebrospinal fluid or blood.Nevertheless, we have tested the device to the best of our abilities.Based on our examination results, we can confirm the blockage in the shunt system.Visible dried deposits on the product as well as a deformation of the peritoneal catheter behind the valve could be detected.In addition, traces of instruments/clamps were visible on the kink protection catheter, in the area of the deformed catheter.Retrospectively, it is not possible to determine the reason for the blockage, deformation and the deposits.As described in our instructions for use, the permeability is recommended to be checked with nacl before using the valves.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• 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: 15936530
• Report Number: 3004721439-2022-00369
• Device Sequence Number: 6403792
• Product Code: JXG
• UDI-Device Identifier: 04041906116002
• UDI-Public: 4041906116002
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 20060518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• 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