MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939352050
Medical Device Problem Codes	Poor Quality Image (1408); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified distal left anterior descending artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, there was difficulty interpreting the image due to imaging issues and failure to cross the lesion because of calcification.The procedure was not completed due to this event and was rescheduled.The patients condition was fine, and no complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified distal left anterior descending artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, there was difficulty interpreting the image due to imaging issues and failure to cross the lesion because of calcification.The procedure was not completed due to this event and was rescheduled.The patients condition was fine, and no complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed a kinked sheath.The catheter flushed normally with the imaging core fully retracted and advanced.Impedance testing showed no electrical issues, and image characterization produced a good square image in the ilab system.

• Brand Name: OPTICROSS? HD
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23303676
• Report Number: 2124215-2025-68335
• Device Sequence Number: 13256953
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260423(10)36356748
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K213593
• 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): 12/18/2025

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 Expiration Date: 04/23/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0036356748
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 67 YR
• Patient Sex: Male