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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR

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BOSTON SCIENTIFIC CORPORATION ILAB ULTRASOUND IMAGING SYSTEM; CATHETER, ULTRASOUND, INTRAVASCULAR Back to Search Results
Model Number 8864
Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2018
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.During procedure, an image froze during imaging and mdu overload message was displayed.The device froze during pullback.No patient complications were reported.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
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 Key7886036
MDR Text Key120577079
Report Number2134265-2018-61068
Device Sequence Number1
Product Code DQK
UDI-Device Identifier08714729761235
UDI-Public08714729761235
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0000007420
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/23/2018
Initial Date FDA Received09/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2011
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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