BOSTON SCIENTIFIC - GALWAY FLEXTOME® CUTTING BALLOON®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number H749CBM3350100 |
Device Problems
Break (1069); Device Damaged Prior to Use (2284)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.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 shaft of the balloon separated.A 10/3.50 flextome cutting balloon was selected for use.During preparation, the physician took the balloon out of the hoop; however, the shaft of the balloon separated.The device was discarded and was replaced with another of the same flextome cutting balloon; however, upon inflation, the device would not hold air.The physician opted to put in a stent and completed the case.There were no patient complications reported.
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Search Alerts/Recalls
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