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

Model Number	H74939352050
Medical Device Problem Codes	No Display/Image (1183); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified distal left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound examination.During the procedure, blackout issues were encountered with the ivus catheter, which disrupted imaging and created challenges during the procedure.Despite repeated user attempts to eliminate air bubbles through multiple flushing, the issue persisted.The procedure was completed with another of the same device.The patients condition was good, and no complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified distal left anterior descending artery.The opticross hd imaging catheter was selected for intravascular ultrasound examination.During the procedure, blackout issues were encountered with the ivus catheter, which disrupted imaging and created challenges during the procedure.Despite repeated user attempts to eliminate air bubbles through multiple flushing, the issue persisted.The procedure was completed with another of the same device.The patients condition was good, and no complications were reported.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed no issues, and the device appeared to be in good condition.Impedance testing revealed no electrical issues with the device and a good square image appeared in the ilab system during image characterization testing.During the flush test, the device flushed normally when the telescope was fully retracted and fully advanced.No signs of leak were observed.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 device problem excluded following a review of the returned device, reported event details, available information, and product record review.In this case, the device performed as intended during the analysis, and no damage was found that could have contributed to the reported allegation.

• 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: 24318265
• Report Number: 2124215-2026-07859
• Device Sequence Number: 4941948
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260913(10)37448611
• 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): 03/31/2026

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: 09/13/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037448611
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2025
• 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: 57 YR
• Patient Sex: Male