MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H74939354080
Medical Device Problem Codes	Poor Quality Image (1408); Material Deformation (2976); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket / 510(k) # k173820, k213593.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosis was located in a mildly tortuous and moderately calcified vessel.The opticross 6 hd imaging catheter was selected for post-stent ultrasound examination of the target lesion.During the procedure, no image was shown.Upon assessment, the catheter appeared twisted.The procedure was completed using an alternate device.No patient complications.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosis was located in a mildly tortuous and moderately calcified vessel.The opticross 6 hd imaging catheter was selected for post-stent ultrasound examination of the target lesion.During the procedure, no image was shown.Upon assessment, the catheter appeared twisted.The procedure was completed using an alternate device.No patient complications.
Additional Manufacturer Narrative
B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket / 510(k) # k173820, k213593.The device was returned for analysis.Visual inspection revealed that the telescope was kinked, and the imaging window was twisted.A broken imaging core (ic), drive, and coaxial cable began 3.3 cm from the distal end of the connector shaft.The guidewire exit port, and the distal section of the tip were in good condition.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.The unit was cut to inspect the other end of the broken ic.

• Brand Name: OPTICROSS? 6 HD
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 22566172
• Report Number: 2124215-2025-48109
• Device Sequence Number: 11738492
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)261202(10)35399117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173820
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0035399117
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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