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

Model Number	H74939354080
Medical Device Problem Codes	Device-Device Incompatibility (2919); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Chest Pain (1776); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	09/02/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k213593.
Event or Problem Description
It was reported that death occurred.The patient presented with st-elevation myocardial infarction.The 70% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.The lad was wires and an opticross 6 hd imaging catheter advanced for intravascular ultrasound (ivus) examination of the target lesion.The target lesion was stented without incident.The guidewire was then redirected, and the opticross catheter advanced; images were successfully captured.Upon removal of the opticross, the guidewire was found to be kinked within the vessel, making removal over the wire difficult.The physician proceeded to remove both the catheter and wire together.An angiogram at that time revealed a perforation in the left main artery.The patient experienced chest pain related to the perforation.A stent was placed in the left main, and an echocardiogram showed minimal perfusion into the pericardium.The patient was intubated and transferred to the icu.Subsequently, the patient decompensated and was returned to the catheterization lab.Additional angiographic imaging showed that the perforation in the left main had slowed, and the echocardiogram revealed minimal effusion.The perforation was attributed to kinking of a non-boston scientific guidewire during removal of the opticross catheter; there was no visible damage to the catheter.The patient died the day after the procedure.The official cause of death was cardiac arrest after extubation.It was about 24 hours from the catheter lab to the patient's cardiac arrest.There was no autopsy but it was stated the patient died presumably of cardiac tamponade.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k213593.D6 device codes: corrected.
Event or Problem Description
It was reported that death occurred.The patient presented with st-elevation myocardial infarction.The 70% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.The lad was wires and an opticross 6 hd imaging catheter advanced for intravascular ultrasound (ivus) examination of the target lesion.The target lesion was stented without incident.The guidewire was then redirected, and the opticross catheter advanced; images were successfully captured.Upon removal of the opticross, the guidewire was found to be kinked within the vessel, making removal over the wire difficult.The physician proceeded to remove both the catheter and wire together.An angiogram at that time revealed a perforation in the left main artery.The patient experienced chest pain related to the perforation.A stent was placed in the left main, and an echocardiogram showed minimal perfusion into the pericardium.The patient was intubated and transferred to the icu.Subsequently, the patient decompensated and was returned to the catheterization lab.Additional angiographic imaging showed that the perforation in the left main had slowed, and the echocardiogram revealed minimal effusion.The perforation was attributed to kinking of a non-boston scientific guidewire during removal of the opticross catheter; there was no visible damage to the catheter.The patient died the day after the procedure.The official cause of death was cardiac arrest after extubation.It was about 24 hours from the catheter lab to the patient's cardiac arrest.There was no autopsy but it was stated the patient died presumably of cardiac tamponade.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k213593.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the catheter was returned entangled over a non-boston scientific kinked guidewire.Microscopic inspection showed the guidewire exit port was damaged, but the distal section of the tip was in good condition.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.Media provided by the client showed partially the catheter with an interaction with a non-boston scientific kinked guidewire.The guidewire appears to be kinked and that the flow appears to be slow in the mid-distal part of the left anterior descending artery.
Event or Problem Description
It was reported that death occurred.The patient presented with st-elevation myocardial infarction.The 70% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending (lad) artery.The lad was wires and an opticross 6 hd imaging catheter advanced for intravascular ultrasound (ivus) examination of the target lesion.The target lesion was stented without incident.The guidewire was then redirected, and the opticross catheter advanced; images were successfully captured.Upon removal of the opticross, the guidewire was found to be kinked within the vessel, making removal over the wire difficult.The physician proceeded to remove both the catheter and wire together.An angiogram at that time revealed a perforation in the left main artery.The patient experienced chest pain related to the perforation.A stent was placed in the left main, and an echocardiogram showed minimal perfusion into the pericardium.The patient was intubated and transferred to the icu.Subsequently, the patient decompensated and was returned to the catheterization lab.Additional angiographic imaging showed that the perforation in the left main had slowed, and the echocardiogram revealed minimal effusion.The perforation was attributed to kinking of a non-boston scientific guidewire during removal of the opticross catheter; there was no visible damage to the catheter.The patient died the day after the procedure.The official cause of death was cardiac arrest after extubation.It was about 24 hours from the catheter lab to the patient's cardiac arrest.There was no autopsy but it was stated the patient died presumably of cardiac tamponade.

• 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: 23124687
• Report Number: 2124215-2025-65396
• Device Sequence Number: 9287589
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270704(10)36897624
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 01/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0036897624
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 12/09/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/21/2025; 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
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH GUIDEWIRE: TERUMO.; RUNTHROUGH GUIDEWIRE: TERUMO.; RUNTHROUGH GUIDEWIRE: TERUMO.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male