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

Model Number	H749518100
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the device sterility was compromised.The stenosed target lesion was located in the left anterior descending artery.The opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter was found to be contaminated.The procedure was completed with another of the same device.The patients condition following the procedure was stable, and no complications were reported.
Event or Problem Description
It was reported that the device sterility was compromised.The stenosed target lesion was located in the left anterior descending artery.The opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter was found to be contaminated.The procedure was completed with another of the same device.The patients condition following the procedure was stable, and no complications were reported.It was further reported that the vessel was mildly tortuous and mildly calcified with 40% lesion stenosis.
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6).E1 initial reporter phone: (b)(6).

• 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: 24066435
• Report Number: 2124215-2026-02357
• Device Sequence Number: 9387602
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261002(10)37599372
• 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): 02/03/2026

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: 10/02/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037599372
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 10/02/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 62 KG