BOSTON SCIENTIFIC - FREMONT (SUD) ULTRASONIC IMAGING CATHETER - CORONARY; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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Model Number UNK97 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/18/2014 |
Event Type
malfunction
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Event Description
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Same case as 2134265-2014-07672 and 2134265-2014-07745.It was reported that automatic pullback failure occurred.The ilab was used in conjunction with a bsc coronary imaging catheter to visualized the unspecified lesion.During left heart catheterization procedure, the motor drive unit (mdu) unable to performed automatic pull back.It did extend, however, it did not retract and the increments displayed did not move as well.It was further noticed that a clicking sound and running motor were not heard.They tried rebooting the ilab and reseated the mdu in sled multiple times 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).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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