Catalog Number AB35W05040135 |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 03/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Month and year only valid.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the an evercross balloon had been used in right superficial femoral artery(sfa).When attempting to withdraw the balloon it appeared to shear off when crossing stents in the right common iliac artery.Multiple manoeuvres were tried to remove the portion of the balloon that had sheared off however, the distal marker could be still seen in the right common iliac artery.The physician elected to trap the broken balloon with a stent.A wire was negotiated past the area and an 8x37 balloon expandable stent was deployed once advanced to the appropriate area.Good blood flow was observed with no evidence of foreign material in the right lower extremity.
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Manufacturer Narrative
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Additional information: the dislodged fragments were trapped with a visipro stent.No injury to the patient as a result of the dislodged stent.Patient has not required any additional treatment.Patient is stable with no further complications reported.If information is provided in the future, a supplemental report will be issued.
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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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Search Alerts/Recalls
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