BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H749CBM3400150 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that balloon detachment occurred.A 4.0 x 15 flextome® cutting balloon® was selected for use.During preparation, outside patient's body, the balloon came off with blue sheath covering the balloon.There were no patient complications reported.
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Search Alerts/Recalls
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