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

Model Number FV304T

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problems Failure of Implant (1924); Patient Problem/Medical Problem (2688)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received, a follow up report will be submitted.

Event Description

It was reported that 3 months and 2 weeks post-operatively the valve became blocked and underdrainage occurred.The device was explanted.Additional information has been requested, however, not yet received.

Manufacturer Narrative

Aesculap inc.(importer, registration no.2916714) is submitting this report on behalf of christoph miethke gmbh & co.Kg (manufacturer, registration no.3004721439).Exemption number: e2017044.Investigation: visual inspection no significant deformations or damage of the valve were detected during the visual inspection.Permeability test a permeability test has indicated that the valve has a blockage.Adjustment test this is a fixed pressure valve.An adjustment test is not applicable.Braking force and brake function test this is a fixed pressure valve.A braking force and brake function test is not applicable.Computer controlled test to investigate the claim of over/under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The valve is tested in both the horizontal as well as the vertical positions.Because the valve is not permeable, a computer controlled test is not possible.Results it should be noted that the paedigav valve was received dry (i.E.Not submersed in liquid as recommended).The investigation of dry items is not significant due to the affect dry deposits of liquid and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.First we performed a visual inspection of the paedigav valve.No significant deformations or damage of the valve were detected during the visual inspection.Next we tested the permeability of the valve.The valve was shown to have a blockage.Due to the non-permeability of the valve the suspicion of underdrainage was unable to be investigated using our computer controlled simulated flow test.Finally, we have dismantled the valve.Inside the valve we have found significant build-up of substances (likely protein).Based on our investigation, we confirm the presence of occlusion in the valve, likely due to the deposits observed inside the valve.As described in our literature, the problem encountered is one of the known, inevitable risk of hc-therapy by shunt implants.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when release from christoph miethke gmbh & co.Kg.

• Brand Name: PAEDIGAV SYSTEM W/PRECHAMB.ON VALVE 4/24
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8592730
• MDR Text Key: 144474096
• Report Number: 3004721439-2019-00102
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K011030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2023
• Device Model Number: FV304T
• Device Catalogue Number: FV304T
• Device Lot Number: 20038862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2019
• Distributor Facility Aware Date: 04/26/2019
• Device Age: 7 MO
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 MO
• Patient Weight: 10