Model Number 3851 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2019 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
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Event Description
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It was reported that balloon rupture occurred.The target lesion was in a severely calcified vessel.A 10mmx2.25mm wolverine coronary cutting balloon monorail was selected for use.During procedure, it was noted that the balloon ruptured at 12 atm upon first inflation.The device was removed without any problem.The procedure was completed with a different device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
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Manufacturer Narrative
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Device evaluated by manufacturer: the device was returned for analysis.Based on the potential hazards/failure modes identified, the following attributes were examined: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified in the balloon which is indictaive of a leak.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located in the mid balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The markerbands, blades and tip section of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination identified multiple kinks on the hypotube of the device.No other issues were identified during the product analysis.
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Search Alerts/Recalls
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