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

Model Number	H749ILAB220CART0
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.A capital equipment ilab ultrasound imaging system was selected for use.During the procedure, the acquisition processor (acq pc) failed to start.The procedure was not completed due to this event.No patient complications were reported.
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.A capital equipment ilab ultrasound imaging system was selected for use.During the procedure, the acquisition processor (acq pc) failed to start.The procedure was not completed due to this event.No patient complications were reported.
Additional Manufacturer Narrative
(b)(6).Investigation results.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Investigation conclusion: the investigation conclusion code of cause not established was selected.Based on a thorough review of the reported complaint, the cause of the reported event could not be determined.

• 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 ; 7634941632
• MDR Report Key: 23790970
• Report Number: 2124215-2025-90633
• Device Sequence Number: 16065682
• Product Code: DQK
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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: H749ILAB220CART0
• Device Catalogue Number: H749ILAB220CART0
• Device Lot Number: 0000008122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 01/09/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown