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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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.
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Manufacturer Narrative
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(b)(6).
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Event Description
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It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.It was further reported that the balloon was simply pulled out from the patient's body and the patient was good post procedure.
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Manufacturer Narrative
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E1.Initial reporter facility name: (b)(6).E1.Initial reporter city: (b)(6).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.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 5mm distal to the distal end of the proximal markerband.An examination of the balloon material and markerband identified no issues which could potentially have contributed to this complaint.A visual and tactile examination identified no kinks or damage to the shaft or hypotube of the returned device.The markerbands 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.A visual and microscopic examination identified damage to the tip of the device.This type of damage is consistent with excessive force being applied to the device when attempting to cross the target lesion.No issues were identified during the product analysis.
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Event Description
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It was reported that balloon ruptured.During a procedure, the 10mm x 2.50mm wolverine coronary cutting balloon ruptured at 6 atmospheres.The device was removed and the procedure completed with another of the same device.It was further reported that the balloon was simply pulled out from the patient's body and the patient was good post procedure.
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Search Alerts/Recalls
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