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 11/20/2019 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, at second inflation, it was noted that the balloon ruptured at 18atm.No resistance was felt during removal of the device.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 a balloon rupture occurred.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, at second inflation, it was noted that the balloon ruptured at 18atm.No resistance was felt during removal of the device.The procedure was completed with a different device.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery 6 and 7.Also, the device was simply pulled out from the patient's body.The patient status post procedure was good.
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Event Description
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It was reported that a balloon rupture occurred.A 10mm x 2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, at second inflation, it was noted that the balloon ruptured at 18atm.No resistance was felt during removal of the device.The procedure was completed with a different device.No patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending artery 6 and 7.Also, the device was simply pulled out from the patient's body.The patient status post procedure was good.
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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.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located at the distal end of the proximal markerband.An examination of the balloon material and proximal 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.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 damage to 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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