MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H749518100
Medical Device Problem Codes	Difficult to Flush (1251); Unable to Obtain Readings (1516); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the middle segment (mlad) of the left anterior descending (lad) artery.An opticross imaging catheter was selected for ultrasound examination of the target lesion.During preparation, the catheter could not be flushed; there were bubbles, and it did not display an image.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Investigation results: media review: media provided by the customer showed that they have difficulties when they try to flush which confirms the as reported catheter difficult to flush.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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 cause not established following a review of the reported event details, available information, and product record review.In this case, an attached media provided by the client shows difficulties when attempting to flush, which confirms the reported issue of catheter difficult to flush.The device was not returned for product analysis, therefore limiting the identification of a most probable cause of the reported event, and batch record review concluded that no manufacturing deviations were identified during the manufacturing process which could have contributed to the reported issue.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.It should be noted that the attached media was only relevant to the catheter difficult to flush reported event and did not provide evidence for the reported events of image missing or device entrapped air.These additional reported events were also assigned an investigation conclusion code of cause not established, as no supporting evidence was available to confirm them.
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the middle segment (mlad) of the left anterior descending (lad) artery.An opticross imaging catheter was selected for ultrasound examination of the target lesion.During preparation, the catheter could not be flushed; there were bubbles, and it did not display an image.The procedure was completed with another of the same device.There were no patient complications.

• 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: 24126060
• Report Number: 2124215-2026-03752
• Device Sequence Number: 5891101
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261016(10)37720375
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037720375
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/12/2026
• Date Device Manufactured: 10/16/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 70 KG