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

Model Number	H7495181360
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 6 imaging catheter was selected for the ultrasound examination of the target lesion.During the procedure, imaging was turned on, and the catheter was advanced slightly.Suddenly, the catheter became tangled around itself.The catheter and wire got stuck, so the physician removed them.The procedure was completed using an alternate method.No patient complications were 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.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed that the device was returned stuck in a non-boston scientific guide catheter and the catheter could not be pulled out due to the conditions which the device returned.The accessories of the catheter were returned, and the device appears to be in good condition.Microscopic inspection showed the guidewire exit port, and the distal section of the tip were in good condition.The rippled imaging window and the imaging core were twisted.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 6 imaging catheter was selected for the ultrasound examination of the target lesion.During the procedure, imaging was turned on, and the catheter was advanced slightly.Suddenly, the catheter became tangled around itself.The catheter and wire got stuck, so the physician removed them.The procedure was completed using an alternate method.No patient complications were reported.

• Brand Name: OPTICROSS? 6
• 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: 23682544
• Report Number: 2124215-2025-86665
• Device Sequence Number: 9707480
• Product Code: OBJ
• UDI-Device Identifier: 00191506035433
• UDI-Public: (01)00191506035433(17)270704(10)36898235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: H7495181360
• Device Catalogue Number: H7495181360
• Device Lot Number: 0036898235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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