BOSTON SCIENTIFIC - FREMONT (CE) ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR
|
Back to Search Results |
|
Model Number UNK71 |
Device Problems
No Display/Image (1183); Retraction Problem (1536); Device Displays Incorrect Message (2591)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/24/2015 |
Event Type
malfunction
|
Event Description
|
Same case as 2134265-2015-03082 and 2134265-2015-03084.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.Also, it was noted that a motor drive unit (mdu) overload has occurred and the automatic pullback failed.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
|
|
Manufacturer Narrative
|
Age at time of event: 18 years or older.(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).
|
|
Search Alerts/Recalls
|
|
|