Model Number 24634 |
Device Problem
Deflation Problem (1149)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Code Available (3191)
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Event Date 10/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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Patient year of birth: 2016.
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Event Description
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It was reported that the balloon could not be deflated and was removed surgically.A 2 cm peripheral cutting balloon was selected for use to dilate a small lung artery.After dilation of the lung artery, the balloon could not be deflated.The physician believes that he may have turned the catheter and the balloon.The patient was sent to the operating room for previously planned surgery.The balloon was successfully removed during that surgical procedure.The patient is fine post-procedure.
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Event Description
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It was reported that the balloon could not be deflated and was removed surgically.A 2cm peripheral cutting balloon was selected for use to dilate a small lung artery.After dilation of the lung artery, the balloon could not be deflated.The physician believes that he may have turned the catheter and the balloon.The patient was sent to the operating room for previously planned surgery.The balloon was successfully removed during that surgical procedure.The patient is fine post-procedure.
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Manufacturer Narrative
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Patient year of birth: 2016.Device analysis by mfr: the balloon was received without the proximal hub section of the device.The polymer extrusion shaft is completely severed approximately 5mm from the balloon bond.This type of damage is consistent with the shaft being cut with a sharp instrument.A visual examination identified that the balloon had been inflated.A high-resolution microscopic examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the blades.All blades were intact and fully bonded to the balloon surface.No issue was observed with the tip or markerbands of the device.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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