MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8668
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone - (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The target lesion was located in the left anterior descending artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter could not be flushed.As a result, the procedure could not be completed.The patient remained stable, and no complications were reported.
Additional Manufacturer Narrative
E1: initial reporter phone - (b)(6).Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record dhr review: it was confirmed that this device met manufacturing specifications before distribution and there were no manufacturing deviations that could have contributed to the reported event.Conclusion: this investigation has been assigned an investigation conclusion code of unable to exclude device problem following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The target lesion was located in the left anterior descending artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During insertion, the ivus catheter could not be flushed.As a result, the procedure could not be completed.The patient remained stable, and no complications were reported.It was further reported that the procedure was completed without the use of an imaging catheter; only the imaging procedure was cancelled.The patient was under local anesthesia and was otherwise treated as planned.The target lesion was 90 percent stenosed, located in a mildly tortuous and mildly calcified left anterior descending artery.

• Brand Name: OPTICROSS HD
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24430546
• Report Number: 2124215-2026-10129
• Device Sequence Number: 16026622
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260915(10)37458239
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173284
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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 Expiration Date: 09/15/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0037458239
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/06/2026
• Date Device Manufactured: 09/15/2025
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 70 KG