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

Model Number	H74939352040
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the telescope and sheath assembly were kinked.No damage or failures were observed on the catheter code pcba (ccp) board assembly or on the hub connector pins, and no damage was found in the imaging core within the telescope and sheath section of the device.Microscope inspection showed that the guidewire exit port was damaged, and the distal section of the tip was damaged and partially detached.Impedance testing showed an electrical open at the proximal end of the catheter between 130 and 140 cm from the distal housing.Functional testing on the motor drive unit (mdu) and the ilab system showed that the catheter was properly recognized by the imaging system when plugged into the mdu, and no connection issues or errors were detected during testing.It was observed that the catheter flushed normally when the telescope was fully retracted and fully advanced.Due to the condition of the returned device, guidewire testing could not be performed.
Event or Problem Description
Reportable based on device analysis completed on 27 january 2026.The opticross hd imaging catheter was returned without any allegation of a device issue.However, device analysis revealed that the distal section of the tip was damaged and partially detached.

• Brand Name: OPTICROSS? HD
• 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: 24370053
• Report Number: 2124215-2026-08902
• Device Sequence Number: 4812525
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)260808(10)37168933
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 08/08/2026
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0037168933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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