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

Model Number	H749518100
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Reduced Blood Flow (4598)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred resulting in patient complications.The patient presented with chest pain.The opticross imaging catheter was selected for ultrasound examination of the target lesion.The catheter was flushed while inside the patient, which resulted in air embolism and slow flow.No actions were taken.The procedure was completed with another opticross catheter.The patient outcome was unknown.
Additional Manufacturer Narrative
B2 outcomes attrib to adv event: corrected.
Event or Problem Description
It was reported that a catheter issue occurred resulting in patient complications.The patient presented with chest pain.The opticross imaging catheter was selected for ultrasound examination of the target lesion.The catheter was flushed while inside the patient, which resulted in air embolism and slow flow.No actions were taken.The procedure was completed with another opticross catheter.The patient outcome was unknown.

• 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: 50588268
• Report Number: 2124215-2026-46408
• Device Sequence Number: 10226110
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)270108(10)38298581
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0038298581
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown