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

Model Number	H749ILAB220CART0
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a device issue occurred, resulting in an aborted procedure.An ilab ultrasound imaging system was used for intravascular ultrasound (ivus) examination of the target lesion.During the ivus procedure, the device could not be started.The procedure was not completed and was rescheduled.No patient complications were reported.
Event or Problem Description
It was reported that a device issue occurred, resulting in an aborted procedure.An ilab ultrasound imaging system was used for intravascular ultrasound (ivus) examination of the target lesion.During the ivus procedure, the device could not be started.The procedure was not completed and was rescheduled.No patient complications were reported.It was further reported that only the imaging procedure was cancelled due to the ilab issue.The patient did not receive the planned treatment, and the procedure was cancelled before the patient was sedated.Local anesthesia had been planned, but was not administered since the procedure was cancelled beforehand.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual inspection, virus scan, and functional check of the returned imaging pc were completed and passed.Investigation conclusion: this investigation is assigned an investigation conclusion code of no problem detected.This conclusion was selected because a thorough review of the reported complaint, available information, and attached documentation did not identify any fault condition related to the reported allegation that the device could not be started.The device passed the functional test.
Event or Problem Description
It was reported that a device issue occurred, resulting in an aborted procedure.An ilab ultrasound imaging system was used for intravascular ultrasound (ivus) examination of the target lesion.During the ivus procedure, the device could not be started.The procedure was not completed and was rescheduled.No patient complications were reported.It was further reported that only the imaging procedure was cancelled due to the ilab issue.The patient did not receive the planned treatment, and the procedure was cancelled before the patient was sedated.Local anesthesia had been planned, but was not administered since the procedure was cancelled beforehand.

• 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: 23358616
• Report Number: 2124215-2025-75581
• Device Sequence Number: 8965024
• Product Code: DQK
• UDI-Device Identifier: 08714729780205
• UDI-Public: (01)08714729780205(11)130124(10)8145
• 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,Followup
• Report Date (Section B): 05/05/2026

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: 0000008145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 04/15/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/13/2025; 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2013
• 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 Age: 59 YR
• Patient Sex: Unknown