Model Number 7590 |
Device Problems
Material Rupture (1546); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2021 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation where a kink was observed in the device.During second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Event Description
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It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely calcified mid left anterior descending artery.A 1.50mm x 20mm maverick balloon catheter was advanced for dilatation where a kink was observed in the device.During second inflation at 12 atmospheres for 21-22 seconds, the balloon ruptured.The device was completely removed and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of a maverick 2mr balloon catheter.The device was microscopically and visually examined.There was contrast in the inflation lumen and the balloon was tightly folded.The balloon had a hole (less than 1mm in length) 8mm from the tip of the device.There was a kink in the tip transition of the device and the tip was damaged.Product analysis confirmed the reported event, as the device was found to have a hole as well as kink damage to the balloon.
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Search Alerts/Recalls
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