MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	44021
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented with may-thurner syndrome complicated by a total thrombus in the left iliac vein for a peripheral intravascular ultrasound (ivus).Following ballooning with a 2.00 x 150 mm sterling balloon, an opticross 18 imaging catheter was selected for ivus.When the catheter was inserted, it was not read by the ivus machine and when removed, the tip of the catheter was found to be broken.The procedure was completed with another of the same device.There were not patient complications reported.

• Brand Name: OPTICROSS 18
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24248793
• Report Number: 2124215-2026-06086
• Device Sequence Number: 13176073
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: (01)08714729904748(17)270327(10)36169443
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K160514
• 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
• Report Date (Section B): 02/03/2026

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: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0036169443
• 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: 01/13/2026
• Initial Report FDA Received Date: 02/03/2026
• Date Device Manufactured: 03/27/2025
• 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: 27 YR
• Patient Sex: Unknown