BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTICROSS? 6 HD

    MDR report key: 23124687 · Received September 23, 2025

    Report

    Report Number
    2124215-2025-65396
    Event Type
    Death
    Date Received
    September 23, 2025
    Date of Event
    September 2, 2025
    Report Date
    January 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OBJ
    UDI-DI
    08714729960775
    PMA / PMN Number
    K173820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K213593. D6 DEVICE CODES: CORRECTED.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    G4: PREMARKET / 510(K) #: K213593.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201270 OPTICROSS? 6 HD CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BOSTON SCIENTIFIC CORPORATION H74939354080 0036897624 08714729960775

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Death RUNTHROUGH GUIDEWIRE: TERUMO.| RUNTHROUGH GUIDEWIRE: TERUMO.| RUNTHROUGH GUIDEWIRE: TERUMO.