Model Number 90495 |
Device Problems
Fluid/Blood Leak (1250); Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device not yet received for evaluation.
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Event Description
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It was reported during the procedure the balloon (subject device) would not inflate and it was leaking.The physician replaced the subject device and completed the procedure without clinical consequences to the patient due to this event.
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Manufacturer Narrative
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The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.H3 other text : device not received for evaluation.
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Event Description
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It was reported during the procedure the balloon (subject device) would not inflate and it was leaking.The physician replaced the subject device and completed the procedure without clinical consequences to the patient due to this event.Additional information received on 03-aug-2021 clarified that the subject balloon would not inflate and was leaking during preparation.No clinical consequences were reported to the patient due to this event.
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Search Alerts/Recalls
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