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); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
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 ultrasound examination of the severely calcified target lesion.Due to the difficulty advancing through the severely calcified plaque, the opticross bent against the coronary guide catheter, causing the opticross catheter to break and the image to be interrupted.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross imaging catheter was selected for ultrasound examination of the severely calcified target lesion.Due to the difficulty advancing through the severely calcified plaque, the opticross bent against the coronary guide catheter, causing the opticross catheter to break and the image to be interrupted.The procedure was completed with a different device.No patient complications were reported.It was further reported that the patient was stable and discharged from the hospital.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross imaging catheter was selected for ultrasound examination of the severely calcified target lesion.Due to the difficulty advancing through the severely calcified plaque, the opticross bent against the coronary guide catheter, causing the opticross catheter to break and the image to be interrupted.The procedure was completed with a different device.No patient complications were reported.It was further reported that the patient was stable and discharged from the hospital.
Additional Manufacturer Narrative
Device analysis findings: the device was returned for analysis.Visual inspection revealed the sheath assembly and imaging window were kinked.Visual and microscopic inspection showed an imaging core windup with broken drive and coaxial cable beginning 26.3cm from the distal end of the connector shaft.Impedance testing showed an electrical open at the proximal end of the catheter.The catheter was properly recognized by the imaging system when plugged into the motor drive unit, and no connection issues or errors were detected during its testing, also, it was observed that the catheter flushed normally when the telescope was fully retracted and fully advanced.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of "adverse event related to patient condition".This conclusion is supported by the following objective evidence.It was noticed that the device was kinked.This failure causes a change in the inner diameter, which can significantly increase the constriction over the catheter.This constriction could lead to the friction that caused the imaging core windup, the broken drive and coax cable.

• 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: 23879907
• Report Number: 2124215-2025-92720
• Device Sequence Number: 17320048
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260909(10)37412482
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2026

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: 09/09/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037412482
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 03/12/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/22/2026; 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2025
• 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: 85 YR
• Patient Sex: Unknown