Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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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) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
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Manufacturer Narrative
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Corrected sections: h3, h6 type of investigation - changed from "device not returned" to "testing of actual/suspected device"; h6 investigation findings - changed from "no findings available" to "no device problem found" trackwise # (b)(4).The device was returned for evaluation on 04/19/2021.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the tip of the delivery device.The delivery device was returned outside the loading device with the seal and tension spring assembly inside the delivery device in an open state.Blood was also observed on the outer part of the intact seal.There were no visual defects observed on the seal.No cracks or delamination was observed on the seal.The white plunger was fully depressed and the blue slide lock was disengaged.The seal and tension spring was removed from the delivery device.No measurements were taken of the delivery device due to the presence of blood which indicates an attempt was made to introduce the device into the aorta.Based on the returned condition of the device, the reported failure "fitting problem" was not confirmed.
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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) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
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Manufacturer Narrative
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Updated sections: g4, g7, h2, h6, h10.Trackwise # (b)(4).The lot # 25151015 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.[ncmr #17080- per 90508578/at and 90520752/aw dunnage product reconciliation form, mcv00052213 and packing list must be attached to each sterile load.Five sterile loads were received at xpo without the dunnage form and packing list attached.Based on the dhr/lhr review results, it was determined that there is a /is no relation between the batch manufacturing process and the reported failure.
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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) was not loaded in the delivery system, so it could not be used.A new device was used as a substitute, and the procedure was completed without any problems.
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Search Alerts/Recalls
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