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Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Activation Problem (4042)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id: (b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack.They followed the procedure, but a sticker (seal) remained in the delivery device.A replacement device was used to complete the procedure.
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Manufacturer Narrative
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Trackwise # (b)(4).
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Event Description
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The hospital reported that during preparation for a coronary artery bypass procedure using hst iii seal (4.5mm), 5-pack.They followed the procedure, but a sticker (seal) remained in the delivery device.A replacement device was used to complete the procedure.No procedural delay.There was no patient effect.
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Manufacturer Narrative
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Trackwise # (b)(4).Updated sections: b4, g4, g7, h2, h6, h10.The lot # 25161070 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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Manufacturer Narrative
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Trackwise # (b)(4).Corrected section: h6-investigation findings -device returned, h3- if other provide code -explain- device returned the device was returned to the factory for evaluation on 01/19/2023.An investigation was conducted on 02/08/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the loading device.The delivery device was returned inside the loading device.A mechanical evaluation was conducted.When performing step 2 of the loading procedure, a greater than normal amount of force had to be applied to push the delivery device down and for the "2" to slide into the window on the loading device.After the force was applied, the delivery device was loaded normally and the seal was deployed with no physical difficulties.He seal and tension spring assembly were removed from the loading device with no physical or visual difficulties.There were no cracks or delamination observed on the seal.Measurements of the delivery device were taken; the inner diameter was measured at 0.196 inches, the outer diameter was measured at 0.22 inches ((b)(4)).The length of the delivery tube was measured at 2.52 inches ((b)(4)).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device, the reported failure "activation problem" was not confirmed, however the analyzed failure "fitting problem", was confirmed.
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Event Description
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N/a.
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Search Alerts/Recalls
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