MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG GAV W.DISTAL CATH.10/40; HYDROCEPHALUS MANAGEMENT

Model Number FV320T

Device Problem Partial Blockage (1065)

Patient Problem Hydrocephalus (3272)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient data - height 180 cm.Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that a gav valve was possibly blocked.A patient underwent a retro-auricular shunt system implantation on (b)(6) 2018.Sometime later, underdrainage was noted; and the patient's cerebrospinal fluid (csf) protein count was also observed to be high.On (b)(6) 2019, the shunt was replaced due to this malfunction.Further details were not available.

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 manufacturing site evaluation: visual inspection - no significant deformations or damage of the valve were detected during inspection.It was noted during observation that the catheter was not securely attached to the valve.Permeability test- the test has indicated that the valve has a blockage.Adjustment test and braking force/function - this is a fixed pressure valve.These tests are not applicable.Results - after the above tests, we have dismantled the valve.Inside the valve we have found a build-up of substances (likely protein).We were unable to closely investigate the claim of over-drainage because the valve is not permeable, and therefore a computer-controlled test was not possible.Based on our investigation, we confirm the presence of occlusion in the valve, likely due to deposits observed inside the valve.As described in our literature, the problem encountered is one of the known, inevitable risks 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 released from christoph miethke gmbh & co.Kg.

• Brand Name: GAV W.DISTAL CATH.10/40
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 8487802
• MDR Text Key: 141071367
• Report Number: 3004721439-2019-00082
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K031303
• 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: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: FV320T
• Device Catalogue Number: FV320T
• Device Lot Number: 20038426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Distributor Facility Aware Date: 04/04/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 90