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

Model Number	8668
Medical Device Problem Codes	Poor Quality Image (1408); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 95% stenosed, 32 x 3.0mm target lesion was located in the moderately tortuous and calcified left circumflex artery (lcx).An opticross hd catheter was selected for intravascular ultrasound examination (ivus) of the target lesion.During initial testing outside the patient, the catheter had bubbles which led to poor image quality.The procedure was completed with another of same device, and the patient was stable following the procedure.
Event or Problem Description
It was reported that a catheter issue occurred.The 95% stenosed, 32 x 3.0mm target lesion was located in the moderately tortuous and calcified left circumflex artery (lcx).An opticross hd catheter was selected for intravascular ultrasound examination (ivus) of the target lesion.During initial testing outside the patient, the catheter had bubbles which led to poor image quality.The procedure was completed with another of same device, and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).Investigation results the complaint device was not received at the complaint investigation site (cis) for analysis.Product record review: 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 details of the reported events, 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 events, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issues.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issues.However, there is no additional detail pertinent to the events.

• 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: 24395381
• Report Number: 2124215-2026-09432
• Device Sequence Number: 9803094
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260905(10)37388490
• 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): 04/03/2026

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: 09/05/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0037388490
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Date Device Manufactured: 09/05/2025
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG