MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939354090
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medsun (b)(4) that a catheter issue occurred.An opticross 6 hd was advanced for ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound catheter became stuck during removal.The wire and catheter were pulled out, and it appeared that the wire had split or the catheter had broken.The procedure was completed.There was no patient complications reported.
Additional Manufacturer Narrative
Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.B3.Date of event was estimated based on the event occurring in (b)(6) 2025.
Additional Manufacturer Narrative
Good faith effort attempts are being made to try and retrieve additional details regarding the reported event, but further information has not been obtained.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) # and other specific product information.B3 date of event was estimated based on the event occurring in november 2025.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.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.Investigation conclusion: this investigation has been assigned an investigation conclusion code of unable to exclude device problem following a review of the reported event details, available information, and product record review.In this case the device was not returned for product analysis therefore limiting the identification of a most probable causes of the reported complaint.Improper handling, device manipulation or not following the correct instructions during the procedure, could be contributing factors to the reported issues.However, there is no additional detail pertinent to the complaint.
Event or Problem Description
It was reported via medsun (b)(4) that a catheter issue occurred.An opticross 6 hd was advanced for ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound catheter became stuck during removal.The wire and catheter were pulled out, and it appeared that the wire had split or the catheter had broken.The procedure was completed.There was no patient complications 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 ; 7634941632
• MDR Report Key: 24500185
• Report Number: 2124215-2026-11741
• Device Sequence Number: 21299675
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K213593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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