Model Number 7010 |
Device Problem
Material Rupture (1546)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2020 |
Event Type
malfunction
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Event Description
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It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in the middle of left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation upon reaching the rated pressure, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
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Event Description
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It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in the middle of left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation upon reaching the rated pressure, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.It was further reported that the lesion was mildly tortuous and severely calcified.The balloon was inflated once and ruptured at 15 atmospheres for 25 seconds.The balloon was removed within the catheter.
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Event Description
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It was reported that balloon rupture occurred.The 35% stenosed target lesion was located in the middle of left anterior descending artery.A 2.75mm x 12mm quantum maverick balloon catheter was advanced for dilatation.However, during inflation upon reaching the rated pressure, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.It was further reported that the lesion was mildly tortuous and severely calcified.The balloon was inflated once and ruptured at 15 atmospheres for 25 seconds.The balloon was removed within the catheter.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a quantum maverick balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.The balloon was tightly folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.Inspection of the remainder of the device presented no other damage or irregularities.
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Search Alerts/Recalls
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