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 12/04/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Age at time of event: 18 years or older.
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Event Description
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It was reported that a balloon rupture had occurred. a percutaneous coronary intervention was being performed on a 90% stenosed, severely calcified and moderately tortuous lesion in the distal right coronary artery.The 10mm x 3.5mm wolverine coronary cutting balloon ruptured on the first inflation at six atmospheres.The procedure was successfully completed with a non bsc device without issue or patient injury.
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Manufacturer Narrative
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Age at time of event: 18 years or older.Device evaluated by mfr: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.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 saline that was present within the 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 located approximately 2mm proximal of the distal markerband.An examination of the balloon material and distal markerband 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 no kinks or issues with the shaft or hypotube of the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.
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Event Description
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It was reported that a balloon rupture had occurred. a percutaneous coronary intervention was being performed on a 90% stenosed, severely calcified and moderately tortuous lesion in the distal right coronary artery.The 10mm x 3.5mm wolverine coronary cutting balloon ruptured on the first inflation at six atmospheres.The procedure was successfully completed with a non bsc device without issue or patient injury.
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Search Alerts/Recalls
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