BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24701 |
Device Problems
Entrapment of Device (1212); Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/24/2019 |
Event Type
malfunction
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Event Description
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It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery to popliteal artery below the knee.After a non-bsc guide wire was passed through, a 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation but was unable to cross the lesion and was stuck on the guidewire.The physician managed to remove the wire and the coyote es from the patient's body together.Upon checking, the coating of the wire got peeled off.The procedure was completed with a different device.No patient complications were reported.
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Event Description
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It was reported that catheter entrapment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery to popliteal artery below the knee.After a non-bsc guide wire was passed through, a 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation but was unable to cross the lesion and was stuck on the guidewire.The physician managed to remove the wire and the coyote es from the patient's body together.Upon checking, the coating of the wire got peeled off.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen.The device had a guidewire inserted and it was unable to be removed.Microscopic inspection revealed inner shaft buckling at 5mm proximal of the marker band and 10mm distal of the marker band, as well as tip damage.The guidewire had buckling on its outer coating.The guidewire had an od of.01346.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any damage or irregularities contributing to the reported crossing difficulty.
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