MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939352050
Medical Device Problem Codes	Poor Quality Image (1408); Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.D2b: pro code (product code): obj.
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.An opticross hd imaging catheter was selected for use in the ultrasound examination.During the procedure, there was difficulty interpreting the image due to image quality issues and crossing was not possible due to calcification.The procedure was not completed due to this event.There was no patient complications reported, and the patient was fine.
Event or Problem Description
It was reported that a device issue occurred resulting in an aborted procedure.The 70% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending (lad) artery.An opticross hd imaging catheter was selected for use in the ultrasound examination.During the procedure, there was difficulty interpreting the image due to image quality issues and crossing was not possible due to calcification.The procedure was not completed due to this event.There was no patient complications reported, and the patient was fine.
Additional Manufacturer Narrative
Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.The device was returned for analysis.Visual inspection revealed no issues and the device appeared to be in good condition.The impedance test showed an electrical open at the distal end of the catheter between 0-10cm from the distal housing.Microscopic inspection revealed the guidewire exit port and the distal end of the tip were in good condition.

• Brand Name: OPTICROSS? HD
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 23304328
• Report Number: 2124215-2025-72884
• Device Sequence Number: 15947601
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260423(10)36356748
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K213593
• 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): 12/02/2025

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: 04/23/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0036356748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2025
• 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: 67 YR
• Patient Sex: Male