Model Number H749A70200 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Same case as: 2134265-2018-00840 and 2134265-2018-00841.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noticed that the sled could not pullback.The procedure was completed with another with same sled.No patient complications were reported and the patient's status is stable.
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Manufacturer Narrative
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Device evaluated by mfr: the device was returned for analysis.The sled was returned on overall good physical condition.The returned sled was able to properly connect to the motor drive unit 5+ and it turned on.Ilab system recognized mdu5+ in place.During functional testing using a test catheter, the sled was able to properly pull back and performed within specifications.The sled was able to be manually pull back with the mdu in place.No other issues or defects were observed during product analysis of the returned device.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).
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Event Description
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Same case as: 2134265-2018-00840 and 2134265-2018-00841.It was reported that automatic pullback failure occurred.An ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noticed that the sled could not pullback.The procedure was completed with another with same sled.No patient complications were reported and the patient's status is stable.
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Search Alerts/Recalls
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