MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES; HYDROCEPHALUS MANAGEMENT

Model Number	FX471T
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a prosa (part # unknown) and progav 2.0 (part # unknown) were implanted during a procedure performed on an unknown date.According to the complainant, the patient underwent a revision procedure on an unknown date.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the revision procedure.Although requested, additional information has not been made available.Same event as medwatch mdr id # 3004721439-2022-00127.
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: the following observations were made during the visual inspection: tissue residues on the catheter.Permeability test: the test showed that the progav® 2.0 combined with the burhole reservoir and the prosa® (rm 4269_1) is permeable.Computer control test: the computer-controlled test showed the opening pressure of the progav® 2.0, at a reference flow rate of 20 ml/h in a horizontal position of the valve, to be 0,92 cmh2o.This is not within the specified tolerance of 10 cmh2o ± 3 cmh2o.An applied pressure of 10 cmh2o, with the device in the horizontal position is expected to have a resultant pressure of 10 cmh2o ± 3 cmh2o.The test result is confirmed by further tests.According to our results, we can detect a presence of an accelerated outflow.Adjustability test: the progav 2.0 was found to be non-adjustable within the specified range.Braking force and brake function test: the braking force test indicates that the brake function of the progav 2.0 is present.Due to the non-adjustability of the valve, as detailed in section 7.4 an investigation of the braking force was not possible.Internal inspection of product: after dismantling of the valve, deposits were found in progav 2.0.Results: for the sake of thoroughness and transparency, we would like to point out that an adjustment test and permeability test was already carried out after the revision at the hospital.Based on our investigation results, we can determine an accelerated outflow and a non-adjustability in the valve at the time of our investigation.Detected deposits can be named as the cause of the malfunctions.Existing deposits in the csf may temporarily impair the function of the valve and are described concomitants in the hydrocephalus therapy.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.From our point of view, no further regulatory actions are required.

• Brand Name: PROGAV 2.0 SYS PED.W/SA20 A.BURRHOLE RES
• 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: 14269652
• Report Number: 3004721439-2022-00126
• Device Sequence Number: 20056836
• Product Code: JXG
• UDI-Device Identifier: 04041906138165
• UDI-Public: 4041906138165
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/21/2019
• Device Model Number: FX471T
• Device Catalogue Number: FX471T
• Device Lot Number: 20025237
• 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: 04/08/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2014
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Weight: 41 KG