MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH PED.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number	FX466T
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	12/27/2022
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 a progav 2.0 with ped.Prechamber (part # fx466t) was to be used during a shunt implant procedure performed on (b)(6) 2022.According to the complainant, the catheter was loose and separating from the reservoir.The issue was noted when the device was removed from the box.No surgical delay or patient impact occurred as a result of the event.
Additional Manufacturer Narrative
Investigation: visual inspection: the following observations were made during the visual inspection: bloody residues on the ligature.Scratches on the pediatric prechamber.Kink protection shifted.A tensile test was performed.No abnormalities were detected during the test.The spout and the catheter are fixed in place.Results: based on our investigation results, we can detect a displacement at the kink protection.However, the shift has no impact on the function of the device.We can exclude a defect at the time of release.The product met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV 2.0 WITH PED.PRECHAMBER
• 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: 16258304
• Report Number: 3004721439-2023-00001
• Device Sequence Number: 4758081
• Product Code: JXG
• UDI-Device Identifier: 04041906137502
• UDI-Public: 4041906137502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161853
• 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
• Report Date (Section B): 02/24/2023

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: FX466T
• Device Catalogue Number: FX466T
• Device Lot Number: 20061571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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