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

Model Number	H749518100
Medical Device Problem Codes	Difficult to Flush (1251); Nonstandard Device (1420); Unable to Obtain Readings (1516); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion, measuring 12 mm in length with a vessel diameter of 2.5 mm, was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound (ivus) examination.During preparation of the ivus catheter outside the patient, bubble retention was observed and could not be cleared.As a result, the catheter could not be flushed, and the image remained completely black throughout.The procedure was completed with another of the same device.The patients condition was stable, and no complications were reported.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical evaluation could not be performed.However, a review of the media provided by the customer showed a poor image on the display.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion, measuring 12 mm in length with a vessel diameter of 2.5 mm, was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound (ivus) examination.During preparation of the ivus catheter outside the patient, bubble retention was observed and could not be cleared.As a result, the catheter could not be flushed, and the image remained completely black throughout.The procedure was completed with another of the same device.The patients condition was stable, and no complications were reported.

• Brand Name: OPTICROSS
• 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: 23766443
• Report Number: 2124215-2025-90065
• Device Sequence Number: 15888598
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260916(10)37468929
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123621
• 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): 01/14/2026

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: 09/16/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037468929
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 09/16/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG