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

Model Number	8668
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the right coronary artery (rca).An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.After priming the catheter, imaging was initiated and saline was pushed in.A foreign body was found at the tip of the catheter, so the original catheter was not used.A new ivus tube was used for the procedure, and the procedure was successfully completed.There were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Investigation results: media review: media provided by the customer showed that the distal housing was detached.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 specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of failure to follow instructions based on a review of the reported event details, available information, and product records.The device was not returned for analysis and according to the complaint information, the catheter was advanced through a lesion with 100% stenosis, which is inconsistent with the instructions for use (ifu).The ifu states that the catheter should not be advanced if resistance is encountered, should not be forced through a tight stenosis, or inserted into lumens narrower than the catheter body, as this may cause device damage.There was no evidence of any issue with the ifu content, wording, translation, or graphics.
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the right coronary artery (rca).An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.After priming the catheter, imaging was initiated and saline was pushed in.A foreign body was found at the tip of the catheter, so the original catheter was not used.A new ivus tube was used for the procedure, and the procedure was successfully completed.There were no patient complications.

• 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: 24391890
• Report Number: 2124215-2026-09374
• Device Sequence Number: 10504818
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260630(10)36869521
• 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): 04/02/2026

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: 06/30/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0036869521
• 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: 03/10/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 06/30/2025
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 69 KG