MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROGAV 2.0 W/SA2.0 20 & DISTAL CATHETER; HYDROCEPHALUS MANAGEMENT

Model Number	FX438T
Medical Device Problem Codes	Partial Blockage (1065); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Hydrocephalus (3272)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Aesculap inc.(importer) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer).Exemption number: e2017044.Manufacturing site evaluation: evaluation on-going.
Event or Problem Description
Country of complaint: (b)(6).It was reported that there is blockage in the valve.
Additional Manufacturer Narrative
The valve was returned using the returnkit and was inserted in an unknown liquid.When delivered for examination, the valve was at pressure level 2 cmh2o.A visual inspection was performed and there were no apparent deformations or other damage on the housing membrane.To check whether the valve was clogged, we performed a permeability test.This test is performed in a hydrostatic pressure difference of approximately 20 - 30 cmh2o.The test showed that the valve is permeable.The investigation showed the valve can be adjusted up and down in all pressure level range.To measure the brake release force, we equipped the valve with a brake force meter.Here, it is measured what force is applied to the housing must be exercised in order to release the rotor by the magnet integrated in the device.The braking function operated properly.The measurement of the braking force was within the expected specification.Based on our findings, we can identify the suspicions of "non-adjustability".However, we suspect that the deposits found in the valve may have temporarily affected the functionality.A defect of the valve can be excluded.No further actions are required.
Additional Manufacturer Narrative
Additional information - a2, a4, b5, d4 (exp.Date, udi), d6a, d6b, d7a, d8, d9, e2, e3, e4, h4 corrected information - b1, b2, g4 (pma/510k), h1.Investigation: visual inspection: slightly scratches on the housing could be detected.Permeability test: a permeability test has shown that the valve is permeable.Adjustment test: the valve was tested and is adjustable to all specified perssures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Result : based on our investigation, we are unable to substantiate the clinical claim of occlusion.At the time of our investigation, the valve was shown to be permeable.No further actions are required from our point of view.
Event or Problem Description
A comprehensive review of the open complaints in the system was performed.Although this event was properly assessed and reported, the follow-up was not submitted.Therefore, the results of the investigation will be submitted subsequently.

• Brand Name: PROGAV 2.0 W/SA2.0 20 & 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,, MO 14469 ; GM 14469
• MDR Report Key: 7236118
• Report Number: 3004721439-2018-00023
• Device Sequence Number: 19135967
• Product Code: JXG
• UDI-Device Identifier: 04041906137434
• UDI-Public: 4041906137434
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K190174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2022

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 Model Number: FX438T
• Device Catalogue Number: FX438T
• Device Lot Number: 20032800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/01/2018
• Initial Date Received by Manufacturer: 12/21/2018
• Supplement Date Received by Manufacturer: 12/21/2018; 02/09/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 09/19/2019; 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2017
• 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: Other; Required Intervention
• Patient Age: 5 MO
• Patient Sex: Unknown
• Patient Weight: 7 KG