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Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/20/2022 |
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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Related to (b)(4).The hospital reported that during a coronary artery bypass procedure, hst iii seal (4.5mm), 5-pack the seal in the delivery sheath is twisted when prepared for hs use and cannot be loaded.The operation was completed with no problems using the new device and the patient is fine.
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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).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.Device not returned.
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Manufacturer Narrative
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Trackwise#: (b)(4).The device was returned to the factory for evaluation on 11/14/2022.An investigation was conducted on 12/14/2022.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The delivery device was returned inside the loading device with the white plunger not depressed and the blue safety on, which prevents the white plunger from being depressed.The delivery device was removed from the loading device with no physical or visual defects observed.The seal and tension spring assembly remained inside the loading device.The seal and tension spring assembly was removed from the loading device with no physical or visual difficulties observed.The seal and tension spring assembly was observed to be intact, with no cracks or delamination observed.Measurements of the delivery device were taken; the inner diameter was measured at 0.195 inches, the outer diameter was measured at 0.221 inches (b)(6).The length of the delivery tube was measured at 2.50 inches (b)(6).The measurement values recorded for the delivery tube were within the tolerance specifications.Based on the returned condition of the device as well as the investigation results and the reported failure "fitting problem" was confirmed.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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Search Alerts/Recalls
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