MAUDE Adverse Event Report: CHRISTOPHER METHKE GMBH & CO. KG PROGAV SYS PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FV441T

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Failure of Implant (1924)

Event Date 12/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Height: 123 cm.For the purpose of this investigation, the progav shunt system is comprised of a progav adjustable pressure valve and a shunt assistant fixed pressure valve.The shunt system was inspected as article fv441t.All parameters have been inspected and approved during the manufacturing process.All parameters have been assessed as meeting specifications.No significant deformations or damage of the valves were defected during the visual inspection.A permeability test has indicated that the shunt assistant has a blockage and the progav valve is permeable.The progav valve was tested and is not adjustable throughout the normal range.The brake functionality test has shown that the brake function did not operate as expected.The results indicate that the rotor no longer performs as required.Based on our investigation, we confirm that the valve is non-adjustable, likely due to the deposits observed inside the valve.In addition, we have detected an over drainage of the progav valve and a blockage of the shunt assistant.We can exclude a defect at the time of release.The shunt system met all specifications of the final inspection when released.

Event Description

It was reported by the healthcare professional: "4 year post operative underdrain, valve not adjustable.The device was explanted.".

• Brand Name: PROGAV SYS PED.W/SA 20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPHER METHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8317705
• MDR Text Key: 135439159
• Report Number: 3004721439-2019-00023
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 4506240662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2019
• Device Age: 4 YR
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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: 6 YR
• Patient Weight: 27