BOSTON SCIENTIFIC CORPORATION COYOTE ES; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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Model Number 24691 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The patient presented with severe lower limb ischemia.The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 3 seconds, the balloon ruptured vertically.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was good.
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Manufacturer Narrative
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Initial reporter address (b)(6).
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Manufacturer Narrative
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E1- initial reporter address 1:(b)(6).Device evaluated by mfr.: returned product consisted of a coyote es balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the shaft and hypotube.There is buckling to the guidewire lumen 18mm from the tip.Microscopic examination revealed that the tip is damaged.The balloon was attempted to be inflated but fluid would leak from a hole in the shaft at one of the kinks.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found a hole in the shaft.
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Event Description
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It was reported that balloon rupture occurred.The patient presented with severe lower limb ischemia.The 100% stenosed target lesion was located in the severely tortuous and severely calcified vessel below the knee.A 1.5mm x 20mm x 143cm coyote es balloon catheter was advanced for dilatation.However, during the first inflation at 10 atmospheres for 3 seconds, the balloon ruptured vertically.The device was removed without any problem and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient condition was good.
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Search Alerts/Recalls
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