BOSTON SCIENTIFIC - FREMONT (SUD) GALAXY INTRAVASCULAR ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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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 03/26/2018 |
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 mdr id: 2134265-2018-03400 and 2134265-2018-03405.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.The target lesion was located in the left anterior descending (lad) artery.During percutaneous transluminal coronary angioplasty (ptca), it was noted that pull back sled was not moving it was stuck in between the case.Thus, automatic pullback failure occurred.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Device evaluated by mfr.: the device was returned for analysis.A pullback accessory sled was returned for evaluation.The sled was returned on overall good physical condition.The returned sled could properly connect to the motor drive unit 5+ (mdu5+).The mdu5+ turned on.Ilab system recognized mdu5+ in place.During functional testing using a test catheter, the sled could properly pull back and performed within specifications.The sled could be manually pull back with the mdu in place.No other issues or defects were observed during product analysis of the returned device.The manufacturing batch record review confirmed that the device met all material , assembly and performance specifications.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 mdr id: 2134265-2018-03400 and 2134265-2018-03405.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.The target lesion was located in the left anterior descending (lad) artery.During percutaneous transluminal coronary angioplasty (ptca), it was noted that pull back sled was not moving it was stuck in between the case.Thus, automatic pullback failure occurred.The procedure was completed with a different device.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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