BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 3820 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2020 |
Event Type
malfunction
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Event Description
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It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.During preparation, the cutting balloon was unpacked, and it was found that the balloon was fractured.The procedure was completed with another of the same device.No patient complications reported.
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Event Description
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It was reported that the device was fractured.A 06/2.75 flextome cutting balloon was selected for use.(b)(6) 2020 during the procedure, the physician unpacked the cutting balloon, it was found the balloon was fractured.The procedure was completed with another of same device.There were no complications reported.It was further reported that the patient was fine post procedure.
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).
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Search Alerts/Recalls
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