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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 10/11/2021 |
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 seal (4.5mm) seal could not be loaded, and the procedure was completed without any problems using a spare heart string.No health hazard to the patient.
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Manufacturer Narrative
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(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.
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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).Updated sections: g4, g7, h2, h6, h10 analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure.Historical data analysis: (4109/213) there were two (2) additional similar complaint(s) reported for the reported failure mode and the reported lot number.A review of the product complaint trend data was performed for the months of ¿june 2021¿ through ¿sept 2021¿.The review does not identify an increasing trend or an adverse trend for three consecutive months for the product family and the failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Device not returned: (4114/3221/67) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
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Search Alerts/Recalls
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