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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); Application Program Problem (2880)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2018
Event Type  malfunction  
Event Description
It was reported that automatic pullback failure occurred. An ilab ultrasound imaging system was used in conjunction with an opticross imaging catheter and pullback sled to view the target lesion. Imaging could be performed, but it could not be recorded. The opticross imaging catheter was replaced, but the issue was not resolved. Automatic pullback failure occurred; however, after replacing with another sled, the issue was resolved. No patient complications were reported.
 
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Brand NameILAB ULTRASOUND IMAGING SYSTEM
Type of DeviceSYSTEM, 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 Key7843915
MDR Text Key119159885
Report Number2134265-2018-60745
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,distri
Reporter Occupation
Type of Report Initial
Report Date 09/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8864
Device Catalogue Number8864
Device Lot Number0000010315
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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