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

Model Number	H749ILAB220CART0
Medical Device Problem Codes	Image Display Error/Artifact (1304); Device Displays Incorrect Message (2591); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.A ce ilab which is used for ultrasound examination of a target lesion.During the procedure, the catheter displayed a black screen after insertion.Upon replacement with another catheter, an error message appeared.The procedure could not be completed due to this event.There were no patient complications.
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.A ce ilab which is used for ultrasound examination of a target lesion.During the procedure, the catheter displayed a black screen after insertion.Upon replacement with another catheter, an error message appeared.The procedure could not be completed due to this event.There were no patient complications.
Additional Manufacturer Narrative
Corrected: e2 - health professional and e3 - occupation.Investigation results: device analysis findings: the device was not returned for analysis; however, the field service engineer (fse) performed an on-site inspection revealed that there was no image after connecting the catheter.After cleaning and reconnecting the acq main unit and motor on-site, testing confirmed normal operation and the equipment was restored to normal use.Risk review: a risk review was completed and confirmed that the event of cancelled/rescheduled - post sedation/sedation unknown (prolonged procedure moderate) was defined in the risk documentation.These event types have been accounted for during product risk analysis.Investigation conclusion: this investigation is assigned an investigation conclusion code of cause traced to component failure.This conclusion was selected because the reason for the catheter displayed a black screen after insertion was most likely determined to be the acq main unit and motor the fse analysis onsite and additional available information.Furthermore, fse cleaning and reconnecting of the acq main unit and motor has resolved the complaint.

• 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: 23279242
• Report Number: 2124215-2025-70605
• Device Sequence Number: 12975348
• Product Code: DQK
• UDI-Device Identifier: 08714729780205
• UDI-Public: (01)08714729780205(11)110601(10)7405
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 0000007405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 06/01/2011
• 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