MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYST.PED.W/SA 20 A.PRECHAMBER; HYDROCEPHALUS VALVES

Model Number FV441T

Device Problem Overcorrection (3006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2018

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 revision surgery was done due to the pressure adjustment failure.".

Manufacturer Narrative

Investigation: optical inspection first step of our investigation is the optical inspection.We can see scratches but no other deformations of the membrane of the housing.The measurement of plane parallelism showed a value slightly out of tolerance at -0.044mm (tolerance +/- 0,02mm).Permeability test to proof the penetrability we carried out a permeability test.This test was carried out at a hydrostatic pressure difference of approx.20-30cmh2o in the direction of flow.The investigation has shown that the progav valve was permeable.Adjustment test our adjustment tests are carried out with the standard progav check mate and measurement tool.The vlave is adjusted from 0 up to 20cmh2o and down again in the same way in steps of 5cmh2o.It was found that no adjustability was possible.Braking force and brake function test to measure the braking force we have investigated the valve with a braking force apparatus.Here it is measure how much force must be exerted on the housing of the progav valve to release the rotor to adjust the valve by the integrated magnets.The measurement of the braking force could not be investigated because it was not possible to adjust the balbe as described under "adjustment test".Result first, we performed a visual inspection of the progav valve.We have detected scratches but no deformation of the membrane of the housing.The measurement of the parallelism showed a slight deviation from the specification.Permeability test of the progav valve was positive.Furthermore, it was not possible to adjust the progav valve.To proof if the brake function is full in place we carried out a rake function test.The measurement of the braking force could not be investigated because it was not possible to adjust the valve as described in "adjustment test." in order to verify whether the valves were influenced by the known risks of hydrocephalus therapy, as for example by natural substances (protein, blood or tissue particles) in the cerebrospinal fluid, we have finally opened the valves.After opening the progav we found intense deposits inside the valve.Based on our investigation results we confirm that the progav was not adjustable.We suspect that the found deposits could have affected the function of the valve.Further actions no further actions are required from our point of view.

• Brand Name: PROGAV SYST.PED.W/SA 20 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam d, 14469 ; GM 14469
• MDR Report Key: 7912454
• MDR Text Key: 121845603
• Report Number: 3004721439-2018-00234
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: FV441T
• Device Catalogue Number: FV441T
• Device Lot Number: 4504182388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Distributor Facility Aware Date: 09/10/2018
• Device Age: 6 YR
• 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
• Patient Age: 6 YR