Model Number H749RB4350100 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous left anterior descending coronary artery.A 3.50 mm x 10 mm flextome cutting balloon was selected for use.During the 5th inflation, the balloon ruptured at 12 atmo for 20 secs.The procedure was completed with a different device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr.: device was returned for analysis.A visual examination identified 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 returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole at 2.0mm distal to the distal end of the proximal marker band.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.The hypotube was kinked at several locations along its length and the shaft polymer extrusion was also kinked at the port bond.The midshaft was also noted to be kinked 40mm distal of the midshaft to polymer extrusion bond.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 balloon rupture occurred.The 90% stenosed target lesion was located in the moderately calcified and moderately tortuous left anterior descending coronary artery.A 3.50mm x 10mm flextome¿ cutting balloon¿ was selected for use.During the 5th inflation, the balloon ruptured at 12 atm for 20secs.The procedure was completed with a different device.No patient complications were reported.
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Search Alerts/Recalls
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