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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
Medical Device Problem Code Application Program Problem (2880)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/22/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that failure to record occurred.The target lesion was located in the coronary artery.A 120v ce ilab ultrasound imaging system was used.During procedure, the unit was not recording.Two catheters were attempted, but the unit still did not record, so the physician aborted the procedure.No other details were given and no specific error message was provided.There were no known consequences to the patient.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Common Device Name
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10277423
Report Number2134265-2020-09326
Device Sequence Number2485081
Product Code DQK
UDI-Device Identifier08714729810032
UDI-Public08714729810032
Combination Product (Y/N)N
Initial Reporter StateMO
Initial Reporter CountryUS
PMA/510(K) Number
K151613
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/15/2020
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
Operator of Device Health Professional
Device Model Number8864
Device Catalogue Number8864
Device Lot Number0000004379
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/22/2020
Initial Report FDA Received Date07/15/2020
Patient Sequence Number1
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