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

Model Number	H749518100
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed the telescope and the sheath were kinked.The impedance test shows an electrical open at the proximal end of the catheter between 130-240 cm from the distal housing.Microscopic inspection revealed drive cable twisted, and the imaging window had ripples.Device history record (dhr) review: it was confirmed that this device met manufacturing specifications before distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of "failure to follow instructions." according to the instructions for use (ifu), the motor drive unit (mdu) must be off during the insertion of the device until it reaches the region of interest.Per the event information, however, the mdu was on during the catheter insertion.Having the mdu on while advancing can significantly increase the constriction over the catheter and cause an electrical failure since the device is not designed to withstand the forces encountered when advancing while rotating.The material twisted noted on analysis is also evidence of advancing the device into patient while rotating.
Event or Problem Description
Reportable based on device analysis completed on 05mar2026.It was reported that visualization issues occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending (lad) artery.An opticross imaging catheter was advanced for the ultrasound examination of the target lesion.During the procedure, dark image occurred.The procedure was completed with another of the same device.There was no patient complications reported, and the patient was stable.However, returned device analysis revealed twisted drive cable and the imaging window had ripples.

• 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: 24717584
• Report Number: 2124215-2026-17000
• Device Sequence Number: 12292578
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261027(10)37806352
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 03/27/2026

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: 0037806352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• 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: 76 YR
• Patient Sex: Male