Catalog Number AB14W050040150 |
Device Problems
Entrapment of Device (1212); Fracture (1260); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/18/2019 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician used a nanocross elite with a 6fr non-medtronic sheath and nitrex wire during treatment of a 150mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm.
Moderate vessel tortuosity and severe calcification are reported.
Ifu was followed.
No issues noted to packaging prior to use.
No issues noted when removing he device from the packaging.
The device was prepped without issue.
A non-medtronic inflation device was used with heparinized saline and contrast for balloon inflation.
The device was passed through a previously deployed stent without resistance.
It is reported that on the second inflation when the balloon was inflated to 14atm, the device became caught on a stent.
Resistance was encountered during withdrawal and excessive force was used.
The balloon is reported to have fractured.
A snare was used to remove the detached balloon fragment from the patient.
No patient injury reported.
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Manufacturer Narrative
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Additional information: the device passed through a previously deployed 6x150 everflex stent without resistance.
There were no issues caused to the stent.
No further patient injury was reported for this event.
If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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