MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO. KG PROGAV SYS PED.W/SA 15 A.PRECHAMBER; HYDROCEPHALUS MANAGEMENT

Model Number FV440-T

Device Problem Reset Problem (3019)

Patient Problem Hydrocephalus (3272)

Event Date 03/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient data - height 140 cm.Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K161853.Manufacturing site evaluation: investigation on-going.Additional information/investigation results will be provided in a supplemental report.

Event Description

It was reported that a progav valve was not adjusting.A patient underwent a shunt system implantation on (b)(6) 2019 and the initial pressure was set to 20cm h2o.On (b)(6) 2019, during the initial reset, the pressure was not able to be adjusted.All available pressure-regulating tools were used in an attempt to change it.On (b)(6) 2019, the shunt was replaced due to this malfunction.It was noted that the original valve was then tested after removal and required 7-8 attempts in order to successfully make an adjustment.Further details are not available.

Manufacturer Narrative

Manufacturing evaluation: the shunt system was received dry (not submersed in liquid as suggested).The shunt assistant was not returned; due to the reason for the complaint, only the progav valve has been investigated in the scope of this report.Visual inspection - a deformation of the outer housing of the progav valve was observed through the visual inspection.The valve housing was subsequently measured and confirmed the presence of a deformation.The housing deformation measured at 0.040 mm, outside the tolerance range.Permeability- testing indicated that the valve has a blockage.Adjustment - the test showed it was adjustable to all specified pressures.Braking force/function - the test showed that the brake function operated as expected.However, the breaking force required was not within the specified tolerances.Results - it should be noted that the valve was received dry.The investigation of dry items is not significant due to the affect dry deposits of liquor and blood can have on product performance.In spite of this, we have investigated the valve to the best of our abilities.The valve was not permeable, but was easily adjustable to all pressure setting.The braking force was lower than expected, confirming the valve's easy adjustability.Based on our investigation, we are unable to substantiate the claim of non-adjustability.However, ti is possible that the observed deformation could have compromised the system and could be responsible for the suspected malfunction in the past.The cause of the deformation of the valve and the resultant compromise of the system could not be determined through our investigation.Significant outside pressure, for example by too much force from the adjustment tool or by a fall or impact to the head of the patient, can compromise the integrity of the valve.We can exclude a defect at the time of release.The valve met all specifications of the final inspection when released from christoph miethke gmbh & co.Kg.

• Brand Name: PROGAV SYS PED.W/SA 15 A.PRECHAMBER
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO. KG; 2 ulanenweg; potsdam, 14469 ; GM 14469
• MDR Report Key: 8484858
• MDR Text Key: 140971560
• Report Number: 3004721439-2019-00100
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2022
• Device Model Number: FV440-T
• Device Catalogue Number: FV440-T
• Device Lot Number: 20033276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Distributor Facility Aware Date: 04/11/2019
• Device Age: 23 MO
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/11/2019
• Supplement Dates FDA Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR
• Patient Weight: 36