MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 WITH SA20 AND DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX420T
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported in accordance to the complainant, the progav 2.0 shunt system (#fx420t) was packaged only in one sterile packaging.However, the surgeon used the device because, they get the information that it was judged to be sterilised.No patient complications were reported as a result of the procedure.
Additional Manufacturer Narrative
Manufacturing and quality control data: the progav 2.0 shunt system was manufactured by a qualified employee on october 2021.Deviations during assembly did not occur.The product was finally tested as article fx420t and released for packaging and sterilization and was sterilized by miethke.The progav 2.0 has a normal pressure range of 0 to 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at set pressures of 0, 5, 10 and 20 cmh2o, and were found to meet specifications.The valve was pre-adjusted to 5 cmh2o in accordance with the specification.The shuntassistant has a fixed pressure of 20 cmh2o.The parameters after completion of the valve assembly were tested at a flow rate of 5 ml/h or 50 ml/h at fixed pressure of 20 cmh2o, and were found to meet specifications.All tested parameters were assessed according to specifications.Conclusion information: according to our quality controls in our process, before shipping, all products are passed several times which several persons controls.We can excluded that a simply sterile packaging has left our company (b)(4).All traceability and monitoring procedures revealed no deviations, and we are not informed of any similar cases.The reason for this event could not be explain for us.Normally, the second outer packaging (externally non-sterile) is removed before entry in the operation room in order to avoid contamination.Perhaps this is the reason that this assumption resulted.The complaint cannot be confirmed.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 WITH SA20 AND 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: 15261572
• Report Number: 3004721439-2022-00243
• Device Sequence Number: 15121424
• Product Code: JXG
• UDI-Device Identifier: 04041906136628
• UDI-Public: 4041906136628
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: FX420T
• Device Catalogue Number: FX420T
• Device Lot Number: 20055514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• 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