Model Number H749RB4250100 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Event Description
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It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary arteries.A 10/2.50 flextome cutting balloon catheter was selected to treat the target lesion.It was noted that the balloon ruptured at 7 atmospheres.The procedure was completed with an nc emerge.No patient complications were reported and the patient's status was good.
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Manufacturer Narrative
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Device evaluated by mfr: the complaint device was returned for evaluation.Device evaluation revealed that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and inflation lumen which is evidence of a device leak.The device was attached to an inflation device, subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole at 1.5mm distal to the distal end of the proximal markerband.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.No other issues were identified during product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
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Event Description
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It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and moderately calcified coronary arteries.A 10/2.50 flextome cutting balloon catheter was selected to treat the target lesion.It was noted that the balloon ruptured at 7 atmospheres.The procedure was completed with an nc emerge.No patient complications were reported and the patient's status was good.
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Search Alerts/Recalls
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