Model Number 24658 |
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 12/22/2020 |
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 the balloon ruptured.The 100% stenosed target lesion area was located in a moderately tortuous and severely calcified below the knee artery.A 2.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atmospheres after being inflated once for 10 seconds.The device was removed using the normal method and the procedure was completed with another of the same device.There were no complications reported and the patient is in good condition after the procedure.
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Manufacturer Narrative
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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 subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied, the balloon was inflated to its rate of burst pressure of 12 atmospheres for 30 seconds using digital timer: g24609, without issue.A vacuum was then applied.The inflation device was verified at 12 atmospheres, before and after.This inflation to rate of burst pressure of 12 atmospheres was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.The rated burst pressure for this device is 12 atmospheres.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination found that the shaft was severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.
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Event Description
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It was reported that the balloon ruptured.The 100% stenosed target lesion area was located in a moderately tortuous and severely calcified below the knee artery.A 2.50mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atmospheres after being inflated once for 10 seconds.The device was removed using the normal method and the procedure was completed with another of the same device.There were no complications reported and the patient is in good condition after the procedure.
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Search Alerts/Recalls
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