Catalog Number SEPX-9-30-135 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/03/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The protege rx was returned for evaluation.The lot number indicated on the device labelling was a744582.The protege rx was inspected.The tuohy borst valve was tightened.Approximately 0.5 of the stent was exposed outside of the catheter shaft.No damage to the stent was noted.No damage to the catheter was noted.Approximately 3cm of the stent remained loaded the catheter shaft.A 0.014" lab gw was unable to be loaded due to an obstruction within the lumen.Likely dried residue from the procedure.The protege rx was inserted the deployment apparatus and was able to deploy the stent at 0.40lbs of force.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician was attempting to use a protege rx self-expanding stent with a non-medtronic 6fr sheath, 0.018 guide wire and 5fr spider embolic protection in a moderately calcified lesion which exhibited 70% stenosis in the distal common carotid artery.The vessel is reported to be little tortuous with 8mm diameter and lesion length of 20mm.There was no damage noted to packaging.No issues noted when removing device from hoop/tray.The device was prepped per ifu with no issued noted.The vessel was pre-dilated.The thumbscrew/lock-pin was checked prior to procedure.The lock-pin was removed when device was inserted in patient.There was no resistance felt when advancing the device and no excessive force used.It was reported that during procedure, physician was unable to deploy stent (deployment issue).The procedure was completed using another protege rx stent.There was no patient injury reported.
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Search Alerts/Recalls
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