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Model Number HSK-3043 |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/20/2024 |
Event Type
malfunction
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Event Description
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The hospital reported that during preparation for a coronary bypass procedure, hst iii system (4.3mm) was prepared according to procedure.However, an incident occurred in which the proximal seal could not be loaded and remained in the device.The seal failed to load properly at step 4.A new device was issued, there was no procedural delay, and the operation was completed without any problems.There were no problems for the patient.
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Manufacturer Narrative
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Tw 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.H3 other text : device discarded.
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Event Description
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N/a.
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Manufacturer Narrative
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Trackwise id#: (b)(4).The lot # 3000347059 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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Search Alerts/Recalls
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