MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION iLab Ultrasound Imaging System; catheter, ultrasound, intravascular

Model Number	H749ILAB240CART0
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During procedure, imaging failed to start error occurred.The procedure was cancelled due to this event.
Additional Manufacturer Narrative
Device eval by manufacturer: the returned product consisted of the acquisition (acq) pc serial number (b)(6).The device passed visual inspection and virus scan.During analysis, the acq pc powered up first time in normal power up conditions and could not connect to the gold ilab station as polaris software was installed was incompatible, the reported complaint of imaging failed to start error was not confirmed.
Event or Problem Description
It was reported that the procedure was cancelled.A capital equipment ilab ultrasound imaging system was selected for use.During procedure, imaging failed to start error occurred.The procedure was cancelled due to this event.

• Brand Name: iLab Ultrasound Imaging System
• Common Device Name: catheter, ultrasound, intravascular
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 21630910
• Report Number: 2124215-2025-16643
• Device Sequence Number: 15536462
• Product Code: DQK
• UDI-Device Identifier: 08714729777694
• UDI-Public: (01)08714729777694
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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 Number: H749ILAB240CART0
• Device Catalogue Number: H749ILAB240CART0
• Device Lot Number: 0000010143
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 06/30/2025; 09/09/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/29/2025; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown