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

Model Number	H749518100
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed, 28 x 3.0 mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad).An opticross catheter was selected for intravascular ultrasound examination (ivus) of the target lesion.During the procedure, the tip became twisted.The procedure was completed with another of same device.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter phone number - (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed, 28 x 3.0mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad).An opticross catheter was selected for intravascular ultrasound examination (ivus) of the target lesion.During the procedure, the tip became twisted.The procedure was completed with another of same device.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter phone number - (b)(6).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: it was confirmed that this device met manufacturing specifications prior to distribution and there were 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 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, alongside the anatomical conditions of the patient, could be contributing factors to the reported issue.However, there is no additional detail pertinent to the event.

• 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: 24497208
• Report Number: 2124215-2026-11636
• Device Sequence Number: 10638260
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261013(10)37692271
• 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): 04/09/2026

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 Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037692271
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 10/13/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG