Model Number SECX-10-60-135 |
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 11/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received for evaluation.The distal portion of the stent was protruding out from the distal end of the catheter outer sheath approximately 2mm.A serpentine coiling of the outer assembly was noted 124 ¿ 128 cm from the distal tip.Maximum peak force was required to deploy stent in the deployment apparatus.The inner shaft (proximal grip) exhibited a bend at 2.26 lbs.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician attempted to use a protege rx carotid stent during treatment of a lesion in the patient¿s mid common carotid artery.There was no calcification.Vessel tortuosity is reported.No damage noted to packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed.The device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Pre-dilation was performed.The device was not passed through a previously deployed stent.No resistance was encountered during advancement of the device.It is reported that the stent was unable to be deployed.The device safely removed from the patient and was replaced with a non-medtronic carotid device.No patient injury reported.
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Search Alerts/Recalls
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