MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG SPRUNG RESERVOIR SET W/DISTAL CATHETER; HYDROCEPHALUS VALVES

Model Number FV046T

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Implant date: unknown.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the valve was removed due to infection after implant.When checking the product after removing, the leakage seemed to occur, however the position of leakage was not found.Additional information: the patient got inflammation, possibly caused by the leakage.Therefore, the revision surgery was done.The patient does not have infection.All med watch submissions related to this report are: 3004721439-2018-00235, 3004721439-2018-00236 (this report).

Manufacturer Narrative

We received the shunt system with sprung reservoir in a returnkit, the valves were submerged in an unknown liquid.The first step of our investigation is a visual inspection.Substances of probably protein was found on the reservoir.Also, we detected scratches on the membrane.In order to investigate if there is a blockage of the reservoir, we flushed the reservoir with water.The reservoir was pumped with liquid.Based on our investigation results we could not detect any failure with this product.We could not find a leakage or breakage.No further actions are required.

Manufacturer Narrative

Investigation optical inspection the first step of our investigation is an optical inspection.We found substances of probably protein on the reservoir.Besides, we detected scratches on the membrane.Permeability test in order to investigate if there is a blockage of the reservoir we flushed the reservoir with water.The reservoir was pumped with liquid and could this again derived.Also over the catheter, the fluid could be drained.Furthermore, when flushing the catheter with test fluid, we have found no leakage.Adjustment test an adjustment test is not applicable.Braking force and brake function test a braking force and brake function test is not applicable.Result first, we performed a visual inspection of the reservoir.In the optical control, we could detect any deposits and scratches on the reservoir.The next we performed a permeability test with the reservoir.The investigation revealed that the reservoir was pumped with liquid and this could be again derived over the catheter.Based on our investigation results we could not detect any failure with this product.We could not find a leakage or breakage.The manufacturing of the shunt system and the in-process controls guarantees the integrity of the product.Further actions no further actions are required from our point of view.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: SPRUNG RESERVOIR SET W/DISTAL CATHETER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 7895298
• MDR Text Key: 120916010
• Report Number: 3004721439-2018-00236
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K141687
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FV046T
• Device Catalogue Number: FV046T
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/10/2018
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention