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 anterior descending branch artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During introduction, the device could not be flushed; as a result, the procedure was not completed.The patient remained stable, and no complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred, resulting in an aborted procedure.The target lesion was located in the anterior descending branch artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During introduction, the device could not be flushed.As a result, the procedure was not 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 this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Investigation 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.The procedure was cancelled/rescheduled - post sedation/sedation due to a device malfunction that resulted in the reported catheter difficult to flush.The device was not returned for product analysis, limiting identification of a most probable cause.Improper handling, device manipulation, failure to follow instructions, or patient anatomical conditions could be contributing factors; however, there is no additional detail pertinent to the event.

• 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: 24381391
• Report Number: 2124215-2026-09171
• Device Sequence Number: 10504980
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260704(10)36898635
• 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): 04/01/2026

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: 07/04/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0036898635
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 07/04/2025
• 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