MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FX442T

Device Problems Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)

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

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

Height: (b)(6).Investigation: visual inspection: the visual examination indicated that the catheter is detached from the shunt assistant and there are scratches on the outer housing of the progav 2.0.Under microscopic observation, one sees clearly that the catheter was torn.No other significant deformations or damage was detected.Permeability test: a permeability test has shown that the catheter is permeable.Results: first, we performed a visual inspection of the system.Scratches on the outer casing of the progav 2.0 were observed through the visual inspection.A tear in the distal catheter was also detected.The end of the distal catheter showed signs of having been torn apart (not cut).Next, we tested the permeability of the catheter.The test results indicate that the distal catheter is permeable.We cannot explain how the tear occurred, but there is a particular problem with still growing patients / children as described in the scientific literature.Here, growth-related shear forces or tensile forces in the connective tissue can occur, which can lead to the need to remove the catheter.It may also happen that the drainage / catheter is not long enough and causes drainage to an unintended location.Another long-term problem of shunt drainage is the calcification of the catheter walls and thus increasing the brittleness of the system.Based on our investigation, we can confirm that the catheter has broken.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.

Event Description

It was reported that the catheter fell out.The reporter indicated that while at an outpatient visit, it was found that the catheter in the ventral of the patient had fallen out.The catheter seemed to have fallen from the shunt assistant.Emergency surgery replacement was performed on (b)(6) 2019.

• Brand Name: PROGAV 2.0 SYS PED.W/SA25 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 9139009
• MDR Text Key: 162441190
• Report Number: 3004721439-2019-00248
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: FX442T
• Device Catalogue Number: FX442T
• Device Lot Number: 20026090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR
• Patient Weight: 9