Model Number HST III SYSTEM (4.3MM) |
Device Problems
Fitting Problem (2183); Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) had quality issues.The diameter of the blocking umbrella exceeds the diameter of the delivery pipe after being loaded, resulting in the failure to release normally.A replacement device was used to complete the procedure.No harm to the patient.
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Manufacturer Narrative
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Trackwise id (b)(4).Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Manufacturer Narrative
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Trackwise #(b)(4).The lot history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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Event Description
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N/a.
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Search Alerts/Recalls
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