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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
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BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 8864
Device Problems Retraction Problem (1536); Loss of Data (2903)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
Device not returning.
 
Event Description
It was reported that automatic pullback failure occurred.A 100v ilab ultrasound imaging system was used in conjunction with an imaging catheter and a pullback sled to view the target lesion.During the procedure, it was noted that the ilab ultrasound imaging system froze during pullback.It did recover after it was restarted, but two patient's data were deleted or disappeared.No patient complications were reported.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
EP TECHNOLOGIES, INC.
150 baytech drive
san jose CA 95134
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key7857396
MDR Text Key119647173
Report Number2134265-2018-60825
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K051679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8864
Device Catalogue Number8864
Device Lot Number0000010901
Was Device Available for Evaluation? No
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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