MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	H74939322120C0
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter 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, on the first connection when the opticross was inserted, the ivus system polaris was indicated as a simulator, and it was unable to complete the case.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event was estimated based on aware date as the date was not reported.G4 pma 510 k170204, k191008, k201178.
Additional Manufacturer Narrative
B3 date of event was estimated based on aware date as the date was not reported.G4 pma 510 k170204, k191008, k201178 investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.However, the evidence found within the complaint was reviewed during the course of this investigation, and based on that evidence, the complaint was confirmed conclusion: based on a thorough review of the reported complaint, the cause of the reported event could not be determined, and the case could not be completed.The investigation conclusion code of cause not established was selected.
Event or Problem Description
It was reported that a catheter 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, on the first connection when the opticross was inserted, the ivus system polaris was indicated as a simulator, and it was unable to complete the case.No patient complications were reported.

• Brand Name: ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• 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: 21509858
• Report Number: 2124215-2025-10247
• Device Sequence Number: 8020729
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2026

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: H74939322120C0
• Device Catalogue Number: H74939322120C0
• Device Lot Number: 0000202511
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/05/2026
• Date Device Manufactured: 03/29/2021
• 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