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

Model Number	H749518100
Medical Device Problem Codes	No Display/Image (1183); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 11mar2026.It was reported that a catheter issue occurred.The 96% stenosed target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter could not show the image.The procedure was completed with another of the same device.There were no patient complications reported and the patient condition following the procedure was stable.However, device analysis revealed the catheter was twisted.
Additional Manufacturer Narrative
E1 initial reporter facility name: (b)(6).E1 initial reporter phone: (b)(6).Investigation results: media review: media provided by the customer showed there was no image.Device analysis findings: the device was returned for analysis.Visual inspection revealed the sheath was kinked.Impedance testing showed an electrical open at the distal end of the catheter between 10-20 cm from the distal housing.Microscopic inspection showed the catheter was twisted and the imaging window had ripples.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.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) shall remain off when inserting the device into the patient.However, the device analysis finding of material twisting is evidence of advancing the device into the patient while the mdu is on so that the device is rotating.

• 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: 24758114
• Report Number: 2124215-2026-17976
• Device Sequence Number: 15728592
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260728(10)37068611
• 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
• Report Date (Section B): 04/01/2026

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: 07/28/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037068611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 64 KG