Model Number 3851 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine was selected for use.During the procedure, it was noted that the balloon ruptured at 11 atm.Only the device was removed without problems and the procedure was completed with another of the same device.No patient complications were reported.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination of the balloon identified no tears or holes in the balloon material.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon, when a pinhole leak was identified in the distal transition zone in the balloon.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 12 atmospheres as per wolverine ifu.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination identified no issues.A visual and tactile examination identified no issues.The markerbands and tip and 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.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 occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 10mmx3.00mm wolverine was selected for use.During the procedure, it was noted that the balloon ruptured at 11 atm.Only the device was removed without problems and the procedure was completed with another of the same device.No patient complications were reported.
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Search Alerts/Recalls
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