MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross; catheter, ultrasound, intravascular

Model Number	H749518100
Medical Device Problem Codes	Difficult to Flush (1251); Unable to Obtain Readings (1516); Failure to Advance (2524); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The opticross imaging catheter was selected for intravascular ultrasound examination.During preparation, solution could not be injected through the catheter.The device was examined and evidence indicated that the conduit was blocked, preventing the flush from being performed.Air was observed throughout the catheter and could not be removed.The device did not enter the patient and the procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
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 opticross imaging catheter was selected for intravascular ultrasound examination.During preparation, solution could not be injected through the catheter.The device was examined and evidence indicated that the conduit was blocked, preventing the flush from being performed.Air was observed throughout the catheter and could not be removed.The device did not enter the patient and the procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.H6 device codes: corrected.H6 impact codes: corrected.

• 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 ; +1(612)875-7234
• MDR Report Key: 25659541
• Report Number: 2124215-2026-34561
• Device Sequence Number: 10379595
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K123621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 09/07/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037393159
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2025
• 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 Sex: Unknown