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

Model Number	H749518130
Medical Device Problem Codes	Leak/Splash (1354); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.An opticross imaging catheter was selected for the ultrasound examination of the target lesion.During preparation, the technician noticed that the flushing tubing was leaking, which prevented proper air removal.The procedure was completed with another of same device.The patient remained stable after the procedure.
Event or Problem Description
It was reported that catheter issue occurred.An opticross imaging catheter was selected for the ultrasound examination of the target lesion.During preparation, the technician noticed that the flushing tubing was leaking, which prevented proper air removal.The procedure was completed with another of same device.The patient remained stable after the procedure.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.Investigation conclusion: this investigation has been assigned an investigation conclusion code of cause not established following a review of the reported events details, available information, and product record review.The device was not returned for analysis, limiting further assessment.Improper handling, device manipulation, or not following instructions may have contributed, but no additional information was available.

• Brand Name: OptiCross?
• 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(612)875-7234
• MDR Report Key: 50614139
• Report Number: 2124215-2026-47338
• Device Sequence Number: 16110763
• Product Code: OBJ
• UDI-Device Identifier: 00191506035396
• UDI-Public: (01)00191506035396(17)270413(10)39073655
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K213593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

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 Model Number: H749518130
• Device Catalogue Number: H749518130
• Device Lot Number: 0039073655
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 04/13/2026
• 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