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

Model Number	H74939354090
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.An opticross 6 hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the non-boston scientific guidewire became wrapped around the distal portion of the catheter at the monorail port.The guidewire and catheter were removed together as a single unit, and the vessel was successfully rewired with a new guidewire without issue.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable.
Event or Problem Description
It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified coronary artery.An opticross 6 hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the non-boston scientific guidewire became wrapped around the distal portion of the catheter at the monorail port.The guidewire and catheter were removed together as a single unit, and the vessel was successfully rewired with a new guidewire without issue.The procedure was completed with another of the same device.There were no patient complications, and the patient was stable.
Additional Manufacturer Narrative
Investigation results: media review: media provided by the customer showed wire entanglement with the device.Device analysis findings: the device was not returned for analysis; therefore, a technical evaluation could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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 a conclusion code of failure to follow instructions.This conclusion is supported by the following objective evidence: the device was not returned for product analysis, and the guidewire was found twisted/tangled with the opticross device.Based on opticross catheter twist complaints, it was identified that the increased torque transmission and torque strength of the hubble drive cable can result in sufficient torque build-up in the event of an imaging window kink to cause a twist event when the catheter is advanced into the patient's anatomy with the motor drive unit (mdu) on.Although it could not be confirmed whether the catheter was advanced with the mdu on or off, the twisted material is evidence of advancing the device into the patient's anatomy while rotating.According to the instructions for use (ifu), the mdu shall remain off when inserting the device into the patient's body.Based on this information, failure to follow instructions was assigned as the cause code for the twisted material.

• 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; la aurora - heredia, alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MA 55112 ; +1(763)494-1632
• MDR Report Key: 50550387
• Report Number: 2124215-2026-45856
• Device Sequence Number: 16115043
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/01/2026

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 Model Number: H74939354090
• Device Catalogue Number: H74939354090
• Device Lot Number: 0039333470
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 09/01/2026
• Date Device Manufactured: 05/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI SION; ASAHISION
• Patient Sex: Unknown