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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
It was reported that a capital equipment issue occurred.A ce ilab, which is used for ultrasound examination of a target lesion, was undergoing routine inspection.During this activity, it was noted that a wheel had fallen off.There was no procedure or patient involved.The issue was resolved on site.
 
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Brand Name
ILAB ULTRASOUND IMAGING SYSTEM
Type of Device
CATHETER, ULTRASOUND, INTRAVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18980833
MDR Text Key338757096
Report Number2124215-2024-17706
Device Sequence Number1
Product Code DQK
UDI-Device Identifier08714729780205
UDI-Public08714729780205
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2024
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/07/2024
Initial Date FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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