DATASCOPE CORP SENSATION PLUS 8FR, 50CC FIBER OPTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0684-00-0576 |
Device Problems
Unintended Ejection (1234); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/21/2021 |
Event Type
malfunction
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Event Description
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During an insertion of an intra aortic balloon (iab) catheter, the balloon failed (leaking).The iab catheter was explanted and a new one was replaced.No adverse out come to patient.Product and packaging was not saved.
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Search Alerts/Recalls
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