MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross? 6 HD; transducer, ultrasonic, diagnostic

Model Number	H74939354090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred.The patient presented for an st-elevation myocardial infarction (stemi) procedure involving two layers of existing stents.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified mid-right coronary artery.An opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.The catheter would not cross the lesion, and during the use of a second opticross catheter, the tip broke off.The detached tip remained within the patient and was secured in place by a stent.The procedure was completed using another of the same device.There were no patient complications, and the patient outcome was stable.However, within days, the patient returned with a stemi approximately 20 mm proximal to the location of the retained tip.The last information obtained was that the patient was stable.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: OptiCross? 6 HD
• Common Device Name: transducer, ultrasonic, diagnostic
• 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(763)494-1632
• MDR Report Key: 50161139
• Report Number: 2124215-2026-42206
• Device Sequence Number: 9103617
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457(17)280515(10)39356920
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K213593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939354090
• Device Catalogue Number: H74939354090
• Device Lot Number: 0039356920
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 05/16/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown