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

Model Number	H74939354090
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420); Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.The opticross 6 hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the physician prepped the lesion and then readvanced the opticross catheter to ensure the lesion was ready to be stented.The opticross catheter became stuck on the guidewire and could not be separated.Attempts to push and pull the guidewire and catheter did not resolve the issue.The physician removed both the opticross catheter and the guidewire in one piece.The guidewire could not be separated from the catheter after removal from the patient, and both devices were severely damaged and kinked.The procedure was completed with another of the same device.The patient fully recovered, and no patient complications were reported.

• 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(612)875-7234
• MDR Report Key: 50099646
• Report Number: 2124215-2026-41224
• Device Sequence Number: 13240064
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457(17)280509(10)39300344
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/23/2026

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: H74939354090
• Device Catalogue Number: H74939354090
• Device Lot Number: 0039300344
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2026
• 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 Sex: Unknown