BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR
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Model Number H749ILAB120CARTR0 |
Device Problems
Retraction Problem (1536); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/20/2015 |
Event Type
malfunction
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Event Description
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Same case as: 2134265-2015-01405, 2134265-2015-01406.It was reported that automatic pullback failure occurred.During procedure, an ilab ultrasound imaging system was used in conjunction with an unspecified imaging catheter and a sled to perform automatic pullback.However, it was noted that the automatic pullback stopped and the system gave an error message of a loss of internal computer communication and the previous run will be deleted.The system was rebooted and the procedure was completed with this device.No patient complications were reported.
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Manufacturer Narrative
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(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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Search Alerts/Recalls
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