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

Model Number	H74939352050
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd was advanced for an ultrasound examination of the target lesion.During the procedure, the first one snapped when attempting to use the second.There was no patient complications reported.
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.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the complaint device was not received at the complaint investigation site (cis) for analysis.Device history record (dhr) review: it was confirmed that this device met manufacturing specifications before distribution and there were no manufacturing deviations that could have contributed to the reported event.Conclusion: this investigation has been assigned a conclusion code of cause not established following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable cause of the reported event.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd was advanced for an ultrasound examination of the target lesion.During the procedure, the first one snapped when attempting to use the second.There was no patient complications reported.It was further reported that the catheter broke prior to being inserted into the body, and the procedure was completed using a different opticross catheter.

• 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: 24366175
• Report Number: 2124215-2026-08812
• Device Sequence Number: 17488060
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)261002(10)37610421
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037610421
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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 Sex: Unknown