BOSTON SCIENTIFIC - FREMONT (SUD) ATLANTIS? SR PRO; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number H749389420 |
Device Problems
No Display/Image (1183); 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 05/04/2015 |
Event Type
malfunction
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Event Description
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Same case as 2134265-2015-03268, 2134265-2015-03266, and 2134265-2015-03277.It was reported that automatic pullback failure occurred.During a percutaneous coronary intervention (pci), an ilab ultrasound imaging system was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to visualize the left anterior descending artery.However, it was noted that the catheter failed to show an image.The imaging catheter was then changed with another atlantis¿ sr pro imaging catheter;however, the problem still occurred.It was then noted that a motor drive unit (mdu) overload has occurred and the automatic pullback failed.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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Age at time of event: 18 years or older.(b)(4).
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Manufacturer Narrative
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Device evaluated by manufacturer: the complaint device was returned for evaluation.Device analysis revealed that the telescope assembly was able to properly pull back, advance, and retract.One hub wing was bent when the device was received.No other visual damages were encountered upon visual inspection.The hub flaps appeared normal and a good click sound was heard during insertion into the mdu system.Impedance testing shows a good unit wave form.By using a test pullback sled assembly, the catheter was able to properly pull back manually and automatically.The sled was not returned with the catheter the test was performed with a control sled in the complaint lab.The catheter was properly recognized by the imaging system when plugged into the mdu and not connection issues or errors were detected during its testing.During image characterization testing, a good square image appeared in the ilab system.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
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Event Description
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Same case as 2134265-2015-03268, 2134265-2015-03266, and 2134265-2015-03277.It was reported that automatic pullback failure occurred.During a percutaneous coronary intervention (pci), an ilab ultrasound imaging system was used in conjunction with an atlantis¿ sr pro imaging catheter and a sled to visualize the left anterior descending artery.However, it was noted that the catheter failed to show an image.The imaging catheter was then changed with another atlantis¿ sr pro imaging catheter;however, the problem still occurred.It was then noted that a motor drive unit (mdu) overload has occurred and the automatic pullback failed.The procedure was not completed due to this event.No patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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