MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR; HYDROCEPHALUS VALVES

Model Number FV427T

Device Problem Overcorrection (3006)

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

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported by the healthcare professional to the company sales representative "unable to adjust shunt readings."unable to adjust shunt readings".

Manufacturer Narrative

Manufacturing and quality control data: the progav shuntsystem was manufactured by a qualified employee in march 2018.Deviations during assembly did not occur.The valve was sterilized by miethke and released for shipment after final inspection.The progav valve has a normal pressure rating of 0 to 20 cmws.The valve specifications after closing the valve for 5 ml/h or 50 ml/h, for set pressure range 0, 10, 20 cmh2o were fine.The shuntsystem was inspected as article fv427t.All parameters (opening pressure, reflux, tightness, adjustability and brake function) have been inspected and signed during the manufacturing process.All parameters have been assessed as ok.Before release the progav was pre-adjusted to pressure setting 5 cmh2o.Investigation: optical inspection: first step of our investigation is the optical inspection.The visual inspection has shown evident imprints on the sterile bag, maybe caused by too powerful use of the adjustment tool.In addition, an apparent deformation of the housing can be seen.Braking force and brake function test: the investigation of the progav valve braking force has resulted that the brake function is damaged.Subsequently, the braking force that must be exerted on the housing to release the rotor can not be further investigated.Adjusment test: our adjustment tests are carried out with the standard progav check-mate and measurement tool.The progav should be adjusted from 0 up to 20 cmh2o in steps of 5 cmh2o and down again in the same way.It was not possible to adjust the valve.The analysis of the break resulted its function is damaged.The reason for the malfunction of the brake is not to verify retrospectively.Result: first we performed a visual inspection with the valve.The investigation results that the sterile package indicates evident imprints, maybe caused by too powerful use of the adjustment tool.For further information we tried to adjust the valve from 0 cmh2o up to 20 cmh2o and down again in the same way in steps of 5 cmh2o.It was not possible to adjust the progav valve.The analysis of the brake results its function is damaged.From our point of view there is no failure detectable with the valve at the time of delivery.When adjusting a valve preoperatively through the packaging, a moderate force with the adjustment tool is sufficient.Do not use the button.Strong pressure can cause a damage to the housing, which might affect the valve function.It is important to position the adjustment tool in the center of the valve.Please keep the tool in a right angle to the top of the valve.Normally not very much power is necessary to adjust.For pre-operative adjustments we recommend the use of the progav check-mate.

• Brand Name: PROGAV SYSTEM W/SA 20 A.SPRUNG RESERVOIR
• Type of Device: HYDROCEPHALUS VALVES
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, D-144 69; GM D-14469
• MDR Report Key: 7814428
• MDR Text Key: 118246697
• Report Number: 3004721439-2018-00184
• 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: 09/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2023
• Device Model Number: FV427T
• Device Catalogue Number: FV427T
• Device Lot Number: 20036945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Distributor Facility Aware Date: 07/30/2018
• Device Age: 5 MO
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1