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 12/16/2019 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.The severely stenosed target lesion was located in a mildly tortuous and severely calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was advanced for dilitation, however, it was noted that the balloon ruptured at 6 atmospheres on the first inflation.The device was completely removed and the procedure completed with another of the same device.There were no complications reported and the patient status was good.
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Manufacturer Narrative
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Device evaluated by mfr: 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 media 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 media 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 rated burst pressure for this device is 12 atmospheres as per wolverine specification.A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device.The markerbands, tip and blades 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.No issues were identified during the product analysis.
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Event Description
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It was reported that a balloon rupture occurred.The severely stenosed target lesion was located in a mildly tortuous and severely calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was advanced for dilitation, however, it was noted that the balloon ruptured at 6 atmospheres on the first inflation.The device was completely removed and the procedure completed with another of the same device.There were no complications reported and the patient status was good.
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Search Alerts/Recalls
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