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	10/21/2025
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 preparation prior to the ivus procedure, it was found that the acquisition processor (acq pc) could not start up.The procedure was not completed due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; however, the field service engineer (fse) performed an on-site inspection and revealed it was confirmed on-site that the acq failed to start because the memory stick was loose.After the memory stick was reseated and tightened, the computer was restarted and functioned normally, and the functional test passed.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 acquisition processor (acq pc) could not start up was most likely determined to be the memory stick the fse analysis onsite and additional available information.Furthermore, fse reseated of the memory stick has resolved the complaint.
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 preparation prior to the ivus procedure, it was found that the acquisition processor (acq pc) could not start up.The procedure was not completed due to this event.No patient complications were reported.

• 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: 23684977
• Report Number: 2124215-2025-87748
• Device Sequence Number: 13201958
• Product Code: DQK
• UDI-Device Identifier: 08714729780205
• UDI-Public: (01)08714729780205(11)100706(10)6972
• 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): 04/17/2026

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: 0000006972
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 07/06/2010
• 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