Model Number 3824 |
Device Problems
Material Rupture (1546); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2019 |
Event Type
malfunction
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Event Description
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It was reported that the balloon leaked.The target lesion was located in the right coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion and the contrast was leaking.The balloon was then removed without any intervention.The procedure was completed with another of the same device.No complications reported and patient was stable.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified blood inside the balloon which is evidence of a device leak.A visual and microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied but the balloon could not be inflated due to a shaft leak.The markerbands and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.A visual and tactile examination identified that the shaft polymer extrusion was damaged at the guidewire port.The returned device was attached to a boston scientific encore inflation unit.Positive pressure was applied, and liquid was observed to be exiting from a shaft leak located at the guidewire port.This type of damage is consistent with excessive force being applied to the delivery system and the shaft being pushed against the guidewire causing an abrasion.A visual and tactile examination identified that the hypotube was kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
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Event Description
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It was reported that the balloon leaked.The target lesion was located in the right coronary artery.A 15/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not cross the lesion and the contrast was leaking.The balloon was then removed without any intervention.The procedure was completed with another of the same device.No complications reported and patient was stable.
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Search Alerts/Recalls
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