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Model Number 096F6P |
Device Problems
Difficult or Delayed Positioning (1157); Difficult to Advance (2920)
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Patient Problems
Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2023 |
Event Type
malfunction
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Manufacturer Narrative
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We were informed that the swan ganz catheter was not received at our product evaluation laboratory for a full evaluation since it was discarded.Without return of the product, edwards is unable to perform a complete investigation of the reported event.It is not possible to determine what factors may have contributed to it, and therefore no actions could be planned.The manufacturing records were reviewed and there is no indication of a related non-conformance; all process parameters were met and inspections passed successfully.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
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Event Description
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As reported, during right catheterization, this 6f swan ganz catheter did not advance smoothly once it has passed the introducer, leading to difficulties to pass through the central vein and heart cavities, therefore, it was needed to change to a femoral approach with a 6f catheter.There was no allegation of patient injury.The device is not available for evaluation since it was discarded.Patient demographics were requested and unable to be obtained.
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Manufacturer Narrative
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Based on further engineering investigation, the units go through a balloon inflation inspection as part of the manufacturing process.Current risk mitigations include design and manufacturing controls, ifu warnings and cautions, and physician training of device insertion techniques.
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Search Alerts/Recalls
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