MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross? HD; transducer, ultrasonic, diagnostic

Model Number	H74939352050
Medical Device Problem Codes	No Display/Image (1183); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event.A supplemental report will be submitted if additional details become available.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd catheter was advanced for ultrasound examination of the target lesion.However, it was noted under fluoroscopy, that the distal tip was fractured.No images were taken and the device was removed from the patient without harm.The procedure was completed using another catheter.There were no patient complications.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event.A supplemental report will be submitted if additional details become available.The device was returned for analysis.Visual inspection revealed that the imaging core was pulled out, and the retainer clip was missing.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd catheter was advanced for ultrasound examination of the target lesion.However, it was noted under fluoroscopy, that the distal tip was fractured.No images were taken, and the device was removed from the patient without harm.The procedure was completed using another catheter.There were no patient complications.It was further reported that the device did not cross the lesion and was removed as a whole.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd catheter was advanced for ultrasound examination of the target lesion.However, it was noted under fluoroscopy, that the distal tip was fractured.No images were taken, and the device was removed from the patient without harm.The procedure was completed using another catheter.There were no patient complications.It was further reported that the device was removed as a whole and did not cross the lesion as being inserted.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event.A supplemental report will be submitted if additional details become available.Investigation results: device analysis findings: visual inspection revealed that the imaging core was pulled out, and the retainer clip was loose which confirms the reported issue.Investigation conclusion: this investigation has been assigned an investigation conclusion code of cause linked to device but unable to trace more specifically following a review of the reported event details and the available information.The device was returned for product analysis; however, it was not possible to identify the probable cause of the retainer clip issue.This issue does not present a new or unanticipated risk per risk management.

• 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 ; +1(763)494-1632
• MDR Report Key: 23698196
• Report Number: 2124215-2025-87746
• Device Sequence Number: 10231796
• Product Code: OBJ
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K213593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

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: 08/29/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037334250
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 08/19/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/23/2025; 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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: 64 YR
• Patient Sex: Female