MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross HD; catheter, ultrasound, intravascular

Model Number	8668
Medical Device Problem Codes	Unable to Obtain Readings (1516); Material Integrity Problem (2978); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.An opticross hd imaging catheter was selected for intravascular ultrasound (ivus) examination of the target lesion.During preparation, the extension catheter was bulged, it was also noted that the air could not be discharged and the catheter was black during test outside the patient.The procedure was completed with another of same device.The patient was stable following the procedure.
Additional Manufacturer Narrative
E1- initial reporter facility name - (b)(6) hospital.

• 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 ; +1(612)875-7234
• MDR Report Key: 50885291
• Report Number: 2124215-2026-50932
• Device Sequence Number: 9791949
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)270520(10)39390918
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0039390918
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 05/20/2026
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 114 LB