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

Model Number	H74939354080
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914); Paralysis (1997)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173820, k213593 good faith efforts are being made to try and retrieve additional details regarding the reported event.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 6 hd imaging catheter was flushed three times prior to being advanced for an intravascular ultrasound (ivus) examination of the target lesion.During pullback, the staff noticed a dark image and suspected the presence of air in the catheter.The device was flushed while still in the body.No air embolism was observed, although the patient exhibited symptoms commonly associated with one.The device was removed, flushed multiple times, and then reinserted.The staff again observed the same dark image.The device was removed once more and flushed.The patient experienced hypotension and bradycardia, which resolved within 15 minutes.Medications were given to stabilize blood pressure.The procedure was completed using the same device.The patient made a full recovery and there were no other patient complications.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 6 hd imaging catheter was flushed three times prior to being advanced for an intravascular ultrasound (ivus) examination of the target lesion.During pullback, the staff noticed a dark image and suspected the presence of air in the catheter.The device was flushed while still in the body.No air embolism was observed, although the patient exhibited symptoms commonly associated with one.The device was removed, flushed multiple times, and then reinserted.The staff again observed the same dark image.The device was removed once more and flushed.The patient experienced hypotension and bradycardia, which resolved within 15 minutes.Medications were given to stabilize blood pressure.The procedure was completed using the same device.The patient made a full recovery and there were no other patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173820, k213593.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 6 hd imaging catheter was flushed three times prior to being advanced for an intravascular ultrasound (ivus) examination of the target lesion.During pullback, the staff noticed a dark image and suspected the presence of air in the catheter.The device was flushed while still in the body.No air embolism was observed, although the patient exhibited symptoms commonly associated with one.The device was removed, flushed multiple times, and then reinserted.The staff again observed the same dark image.The device was removed once more and flushed.The patient experienced hypotension and bradycardia, which resolved within 15 minutes.Medications were given to stabilize blood pressure.The procedure was completed using the same device.The patient made a full recovery and there were no other patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173820, k213593.The device was returned for analysis.Visual inspection revealed the sheath was kinked.Impedance testing showed an electrical open at the distal end of the catheter between 1-10 cm from the distal housing.The device flushed normally when the telescope was fully retracted and fully advanced with no signs of leakage.

• 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: 22346147
• Report Number: 2124215-2025-41570
• Device Sequence Number: 14652529
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270328(10)36171646
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0036171646
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 06/24/2025; 08/06/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female