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 12/04/2017 |
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 a balloon rupture occurred.The target lesion was located in the severely calcified blood vessel.A 10/2.75 flextome¿ cutting balloon¿ was selected for use.During the procedure, it was noted that the balloon ruptured.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 manufacturer: the 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 lumen which is evidence of a device leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified blood that was present within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the blood before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure and liquid was observed to be leaking from a balloon pinhole approximately 5.5mm distal to the distal end of the proximal marker band.An examination of the balloon material and marker bands 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.No kinks or damage were noted along the shaft of the device.No other issues were identified during the product analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(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 severely calcified blood vessel.A 10/2.75 flextome¿ cutting balloon¿ was selected for use.During the procedure, it was noted that the balloon ruptured.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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