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

Model Number	H749518100
Medical Device Problem Codes	No Display/Image (1183); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name - the first affiliated (b)(6).E1: initial reporter phone -(b)(6).The device was returned for analysis.Visual and microscopic inspection revealed that the sheath was kinked.No damage was found in the imaging core within the telescope and sheath sections of the device.The imaging window had ripples.Impedance testing showed an electrical open at the proximal end of the catheter between 130-140 cm from the distal housing.
Event or Problem Description
Reportable based on device analysis completed on 06dec2025.It was reported that visualization issues occurred.The 77% stenosed; 36 x 4.0 mm target lesion was located in the mildly tortuous and moderately calcified left circumflex (lcx) artery.An opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter was recognized by the system and motor but failed to display an image.The screen remained black even after brightness was increased.The motor connection was reconfirmed and there was no problem.After retesting, the image still failed to appear.Three imaging runs were completed before image loss occurred.The procedure was completed with another of same device and the patient remained stable after the procedure.However, device analysis revealed that the imaging window had ripples.

• 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: 23918492
• Report Number: 2124215-2025-93603
• Device Sequence Number: 18349060
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260207(10)35806731
• 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
• Report Date (Section B): 12/29/2025

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: 02/07/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0035806731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 62 KG