Model Number HST III SYSTEM (4.3MM) |
Device Problems
Crack (1135); Unraveled Material (1664)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id #(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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 system (4.3mm) would not stayed coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) would not stayed coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Trackwise # (b)(4).The device was returned to the factory for evaluation on 19dec2019 and investigation was conducted on 23jan2020.Signs of clinical use and evidence of blood was observed.Traces of blood were observed on the loading device.The delivery device was returned inside the loading device, with the white plunger not depressed and the blue slide lock not engaged.The seal was observed in the loading device window.Based on the position of the seal and the white plunger, we can conclude that the seal was not loaded correctly.The delivery device was removed from the loading device.The seal and tension spring assembly was removed from the loading device.No visual defects were observed on the seal.No cracks were observed on the seal.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.220 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specification.Based on the returned condition of the device, the reported failure "crack" was not confirmed but the analyzed failure "fitting problem" was confirmed.
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Manufacturer Narrative
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Updated sections: a2, g4, g7, h2, h3, h6, h10.Corrected section: device code - changed to crack.Trackwise # (b)(4).The device was returned to the factory for evaluation on 19dec2019 and investigation was conducted on 23jan2020.Signs of clinical use and evidence of blood was observed.Traces of blood were observed on the loading device.The delivery device was returned inside the loading device, with the white plunger not depressed and the blue slide lock not engaged.The seal was observed in the loading device window.The delivery device was removed from the loading device.The seal and tension spring assembly was removed from the loading device.No visual defects were observed on the seal.No cracks were observed on the seal.Based on the returned condition of the device, the reported failure "crack" 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 system (4.3mm) would not stayed coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Event Description
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The hospital reported that during a coronary artery bypass procedure, hst iii system (4.3mm) would not stayed coiled once removed from device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Corrected section: h-3 (device not eval provide code).Trackwise id# (b)(4).The device was returned for evaluation.A follow up report will be submitted when the investigation is completed.
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Search Alerts/Recalls
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