MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS W/SA 20 A.CONTROL RESERVOIR; HYDROCEPHALUS MANAGEMENT

Model Number FV434-T

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the leakage occurred.The reporter indicated that on (b)(6) 2019, it was found that during a intraoperative procedure that the surgeon noticed obvious cerebrospinal fluid leakage at the silica gel connection between the adjustable pressure valve and the gravity valve.All the doctors and nurses who touch the shunt operated according to the standard procedure and did not touch any sharp tools.Additional event details have not been provided.A request for additional information has been made, however, not yet received.

Manufacturer Narrative

Investigation: visual inspection: in the first step of our investigations, we carried out a visual test on the shunt system.Permeability test: to prove the penetrability of the shunt system we have carried out penetrability test.This test is carried out at a hydrostatic pressure of approximately 20-30 cmh2o in the direction of flow.This test is not applicable, because the missing release of investigation.Adjustment test: our adjustment tests are carried out with the standard progav checkmate and measurement tool.The valve is adjusted from 0 to 20 cmh2o and down again in increments of 5 cmh2o.This test is not applicable, because the missing release of investigation.Braking force and brake function test: to measure the braking force, we tested the progav valve with a braking force device.Here it is measured how much force must be exerted on the housing to release the rotor to adjust the valve by the integrated magnet of the braking force device.This test is not applicable, because the missing release of investigation.Results: the visual investigation indicated no damage to the catheter or the other components.There were visible crystalline deposits on the product.Further investigations are not applicable due to the lack of release for investigation.Based on our visual investigation, we are unable to substantiate a leakage between the valves.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: PROGAV SYS W/SA 20 A.CONTROL RESERVOIR
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9384790
• MDR Text Key: 184884885
• Report Number: 3004721439-2019-00283
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K103003
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: FV434-T
• Device Catalogue Number: FV434-T
• Device Lot Number: 20040985
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention