Catalog Number C-HS-3045 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/17/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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.
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system customer loaded the seal into the delivery device according to the procedure.He found part of the seal (the part sticking out from the delivery system) was loosen.A replacement was used to complete the procedure.No patient injury was reported.
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Manufacturer Narrative
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(b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure, hs iii proximal seal system customer loaded the seal into the delivery device according to the procedure.He found part of the seal (the part sticking out from the delivery system) was loosen.A replacement was used to complete the procedure.No patient injury was reported.
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Search Alerts/Recalls
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