MAUDE Adverse Event Report: CHRISTOPH MIETHKE GMBH & CO KG PROSA SYS PROGAV 2.0 & PED.SPRUNG RES.; HYDROCEPHALUS MANAGEMENT

Model Number FX987T

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

Patient Problems Headache (1880); Visual Impairment (2138); Hydrocephalus (3272)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: visual inspection: a deformation of the outer housing of the prosa 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 -0.047 mm, outside the tolerance of 0 ± 0.02 mm.Permeability test: a permeability test has shown that the prosa valve is permeable.Adjustment test: the valve was tested and is adjustable to all specified pressures.Braking force and brake function test: the brake functionality test has shown that the brake function is fully operational and the braking force is within the given tolerances.Computer controlled test: to investigate the claim of under-drainage, the opening pressure is measured using a miethke computer controlled testing apparatus which simulates a cerebrospinal fluid flow.The prosa® valve is operating within acceptable tolerances.Results: first, we performed a visual inspection of the prosa valve.A deformation of the outer housing of the valve was observed through the visual inspection.This deformation was confirmed through a measurement of the plan parallelism.Next, we tested the permeability, adjustability, and opening pressure of the valve, as well as the brake functionality and brake force.The prosa valve operates as expected and met all specifications.Finally, we have dismantled the valve.There were no visible deposits observed inside the valve.Based on our investigation, we are unable to substantiate the claim of under-drainage and a malfunction of the adjustability.At the time of our investigation, the opening pressure and the adjustability of the prosa valve were within the specified tolerances.At the time of the examination, it is not clear to us how the functional impairment occurred.During our examination we could not identify any impairments in the function of the valve.The cause of the deformation of the prosa valve could not be determined through our investigation.Significant outside pressure, for example by too much force from the prosa 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.No further regulatory actions are required from our point of view.

Event Description

It was reported that a prosa shunt system (part # fv770t) (ref.Mdr id 3004721439-2020-00247) was implanted during a procedure performed on (b)(6) 2010.On (b)(6) 2020, the patient presented to the facility with increased fatigue and double vision beginning on sunday (b)(6) 2020.The patient underwent a computed cranial tomography (cct) which revealed clear build-up.The x-ray revealed a correct valve setting and no indication of disconnection or dislocation.The physician punctured the shunt system and removed 12 milliliters (ml) of clear liquid.However, the valve could not be introduced, so a revision surgery was scheduled for the following day.The replacement surgery was performed on (b)(6) 2020.The prosa shunt system was removed and replaced with a progav 2.0 with prosa system (part # fx987t).However, on (b)(6) 2020, the surgeon documented that a second revision was required due to spontaneous adjustment with renewed accumulation of the progav 2.0.The progav 2.0 with prosa system was replaced with a prosa shunt system to successfully complete the procedure.The devices were returned to the manufacturer for evaluation.No further patient complications were reported following the second revision surgery.

• Brand Name: PROSA SYS PROGAV 2.0 & PED.SPRUNG RES.
• Type of Device: HYDROCEPHALUS MANAGEMENT
• Manufacturer (Section D): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer (Section G): CHRISTOPH MIETHKE GMBH & CO KG; ulanenweg 2; potsdam, 14469 ; GM 14469
• Manufacturer Contact: joerg knebel ; ulanenweg 2; potsdam, 14469 ; GM 14469
• MDR Report Key: 10942391
• MDR Text Key: 219489676
• Report Number: 3004721439-2020-00248
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161853
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FX987T
• Device Catalogue Number: FX987T
• Device Lot Number: 20048805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2020
• 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: 33 YR