Model Number H749RB4275100 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.(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 a balloon rupture occurred.The target lesion was located in the moderately tortuous and mildly calcified second of right posterolateral (rpl) artery.A 10/2.75 flextome cutting balloon was used for pre-dilation.During procedure, first inflation was at 8 atmospheres and second inflation was at 10 atmospheres.During third inflation, it was noticed that the balloon ruptured at 10 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The device was attached to an encore inflation unit, subjected to positive pressure and liquid was observed to be leaking from a pinhole in the mid section of the balloon.A visual and microscopic examination observed no damage to the tip, blades, or markerbands.All blades were present and fully bonded to the balloon surface.The hypotube was kinked at several locations along its length.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were identified during the 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 mildly calcified second of right posterolateral (rpl) artery.A 10/2.75 flextome¿ cutting balloon¿ was used for pre-dilation.During procedure, first inflation was at 8 atmospheres and second inflation was at 10 atmospheres.During third inflation, it was noticed that the balloon ruptured at 10 atmospheres.The procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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