Model Number 106A3 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a cryo ablation procedure, a system notice was received indicating that the balloon was not sufficiently inflated.The coaxial umbilical cable, catheter and tank were replaced without resolve.It was noted that the low pressure regulator (lpr) was not within the expected range.The case was aborted while the patient was under general anesthesia.A field service visit took place on a later date and the console was serviced as appropriate.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the data files were returned and analyzed.The data files showed system notice 50013 "the refrigerant level is too low to continue" on the date of the event.The console was serviced by a field service engineer.The console failed the inspection due to a defective low-pressure regulator (lpr) internal kit; the lpr was rebuilt.The product issue reported (system notice was received indicating that the balloon was not sufficiently inflated.) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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