OptiCross H749518100Recalls & reported problems

Summary

The FDA's MAUDE database contains 457 adverse event reports that list this exact device (DI 08714729890393), received between Sep 20, 2018 and Sep 3, 2026 — classified as 2 deaths, 13 injuries, 442 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (163 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 457 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Air/Gas in Device

  It was reported that a catheter issue occurred resulting in patient complications.The patient presented with chest pain. The OptiCross imaging catheter was selected for ultrasound examination of the target lesion. The catheter was flushed while inside the patient, which resulted in air embolism and slow flow. No actions were taken. The procedure was completed with another OptiCross catheter. The patient outcome was unknown.

  Patient problems: Air Embolism; Reduced Blood Flow

  MAUDE report 50588268 ↗
• InjuryAug 3, 2026Entrapment of Device; Detachment of Device or Device Component

  It was reported that a catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery. An OptiCross imaging catheter was advanced for intravascular ultrasound (IVUS) examination of the target lesion. During the procedure, the catheter was advanced over the guidewire to the distal segment for IVUS examination. The patients vessels were extremely tortuous and stenotic, with multiple segments exhibiting angulations greater than 60 degrees. Automatic pullback of the IVUS catheter was not possible, and catheter entrapment with a potential tip fracture was suspected. Attempts to retrieve the catheter by the operator were unsuccessful. The fractured catheter tip remained in the patient, and multiple stents were deployed to completely cover the lesion and secure the fractured tip against the vessel wall. Post dilation was performed repeatedly using a non-compliant balloon to ensure adequate stent apposition. Intensified antiplatelet therapy was administered after the procedure. The procedure was completed with another of the same device. The patient was stable following the procedure. There were no patient

  Patient problems: Foreign Body In Patient

  MAUDE report 50116239 ↗
• MalfunctionJun 29, 2026Difficult to Flush; Unable to Obtain Readings; Failure to Advance; Air/Gas in Device

  It was reported that a catheter issue occurred.The OptiCross imaging catheter was selected for intravascular ultrasound examination. During preparation, solution could not be injected through the catheter. The device was examined and evidence indicated that the conduit was blocked, preventing the flush from being performed. Air was observed throughout the catheter and could not be removed. The device did not enter the patient and the procedure was completed with another of the same device. There were no patient complications.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659541 ↗
• MalfunctionApr 7, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, THE IMAGE WAS LOST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS GOOD, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW WAS RIPPLED AND THE IMAGING CORE WAS ENTANGLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800529 ↗
• MalfunctionApr 1, 2026No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 96% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER COULD NOT SHOW THE IMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE CATHETER WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24758114 ↗
• MalfunctionMar 30, 2026No Display/Image; Poor Quality Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05MAR2026. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, DARK IMAGE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED TWISTED DRIVE CABLE AND THE IMAGING WINDOW HAD RIPPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717584 ↗
• MalfunctionMar 3, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12 FEB 2026. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, IT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS GOOD, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE WAS ENTANGLED WITH THE GUIDEWIRE CABLE. THE CATHETER WAS TWISTED, AND THE IMAGING WINDOW WAS RIPPLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501041 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED, 28 X 3.0MM TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING (LAD). AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING THE PROCEDURE, THE TIP BECAME TWISTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497208 ↗
• MalfunctionFeb 10, 2026Entrapment of Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PREPARATION, THE CATHETER BECAME ENTANGLED WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL AND THE CATHETER AND GUIDEWIRE WERE PULLED OUT TOGETHER AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307287 ↗
• InjuryFeb 10, 2026Entrapment of Device; Nonstandard Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING PROCEDURE, THE GUIDE WIRE WAS KNOTTED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT A 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE GUIDEWIRE USED WAS A NON-BOSTON SCIENTIFIC (NON-BSC) DEVICE. A GUIDE EXTENSION CATHETER WAS USED TO REMOVE THE CATHETER AND WIRE AS ONE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306429 ↗
• MalfunctionJan 27, 2026Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CORONARY ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PROBE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191344 ↗
• MalfunctionJan 20, 2026Difficult to Flush; Unable to Obtain Readings; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MIDDLE SEGMENT (MLAD) OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, THE CATHETER COULD NOT BE FLUSHED; THERE WERE BUBBLES, AND IT DID NOT DISPLAY AN IMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126060 ↗
• MalfunctionJan 14, 2026Contamination

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE IVUS CATHETER WAS FOUND TO BE CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24066435 ↗
• MalfunctionJan 13, 2026Difficult to Flush

  IT WAS REPORTED THAT FLUSHING DIFFICULTIES WERE ENCOUNTERED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING PREPARATION OF THE DEVICE, AFTER CONNECTING IT TO THE SLED, THE HEMODYNAMICS SPECIALIST PERFORMED FLUSHING OF THE IVUS CATHETER AND ENCOUNTERED ABNORMAL RESISTANCE TO THE FLOW OF SOLUTION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059937 ↗
• MalfunctionJan 7, 2026Nonstandard Device; Material Perforation; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING PREPARATION, IT WAS NOTED THAT THERE WAS A HOLE IN THE GUIDEWIRE CAVITY OF THE CATHETER AND THE GUIDEWIRE ENTERED THE INTERNAL CAVITY THROUGH THIS HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990966 ↗
• MalfunctionDec 29, 2025No Display/Image; Nonstandard Device; No Display/Image; Nonstandard Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06DEC2025. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE 77% STENOSED; 36 X 4.0 MM TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WAS RECOGNIZED BY THE SYSTEM AND MOTOR BUT FAILED TO DISPLAY AN IMAGE. THE SCREEN REMAINED BLACK EVEN AFTER BRIGHTNESS WAS INCREASED. THE MOTOR CONNECTION WAS RECONFIRMED AND THERE WAS NO PROBLEM. AFTER RETESTING, THE IMAGE STILL FAILED TO APPEAR. THREE IMAGING RUNS WERE COMPLETED BEFORE IMAGE LOSS OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE PATIENT REMAINED STABLE AFTER THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW HAD RIPPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918492 ↗
• MalfunctionDec 29, 2025Nonstandard Device; Failure to Advance; Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06 DEC 2025. IT WAS REPORTED THAT A CATHETER ISSUES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID LEFT CIRCUMFLEX CORONARY ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; BUT THE IVUS CATHETER COULD NOT CROSS THE LESION DUE TO ANGULATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT WAS STABLE, AND NO COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW HAD RIPPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918477 ↗
• MalfunctionDec 29, 2025Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING INSERTION, THE TIP OF THE CATHETER WAS NOT SMOOTH, GOT STUCK ON THE STENT, AND COULD NOT BE PULLED OUT. THE ISSUE WAS RESOLVED AND THE PROCEDURE COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION HAD A 60% STENOSIS AND WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE DEVICE WAS RELEASED BY GENTLY MOVING IT FORWARD AND BACKWARD. THE STENT WAS A NON-BOSTON SCIENTIFIC (NON-BSC) DEVICE AND WAS NOT DAMAGED; HOWEVER, THE CATHETER TIP HAD A SMALL BURR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908580 ↗
• MalfunctionDec 23, 2025No Display/Image; Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; No Display/Image; Nonstandard Device; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE SEVERELY CALCIFIED TARGET LESION. DUE TO THE DIFFICULTY ADVANCING THROUGH THE SEVERELY CALCIFIED PLAQUE, THE OPTICROSS BENT AGAINST THE CORONARY GUIDE CATHETER, CAUSING THE OPTICROSS CATHETER TO BREAK AND THE IMAGE TO BE INTERRUPTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS STABLE AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879907 ↗
• MalfunctionDec 18, 2025Difficult to Flush; Air/Gas in Device; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE OF CORONARY ARTERY STENT IMPLANTATION; IT WAS FOUND THAT THE CATHETER COULD NOT BE FLUSHED AND CONTAINED BUBBLES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844184 ↗
• MalfunctionDec 10, 2025Nonstandard Device; Connection Problem; Material Deformation; Nonstandard Device; Connection Problem; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED, RESULTING IN AN ABORTED PROCEDURE. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. DURING THE PROCEDURE, THE CATHETER COULD NOT BE CONNECTED DUE TO A DAMAGED TIP. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT REMAINED STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771640 ↗
• MalfunctionDec 10, 2025Difficult to Flush; Nonstandard Device; Unable to Obtain Readings; Air/Gas in Device; Difficult to Flush; Nonstandard Device; Unable to Obtain Readings; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION, MEASURING 12 MM IN LENGTH WITH A VESSEL DIAMETER OF 2.5 MM, WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. DURING PREPARATION OF THE IVUS CATHETER OUTSIDE THE PATIENT, BUBBLE RETENTION WAS OBSERVED AND COULD NOT BE CLEARED. AS A RESULT, THE CATHETER COULD NOT BE FLUSHED, AND THE IMAGE REMAINED COMPLETELY BLACK THROUGHOUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766443 ↗
• MalfunctionDec 10, 2025Difficult to Flush; Unable to Obtain Readings; Air/Gas in Device; Difficult to Flush; Unable to Obtain Readings; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION, MEASURING 15 MM IN LENGTH WITH A VESSEL DIAMETER OF 3.0 MM, WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. DURING PREPARATION OF THE IVUS CATHETER OUTSIDE THE PATIENT, BUBBLE RETENTION WAS OBSERVED AND COULD NOT BE CLEARED. AS A RESULT, THE CATHETER COULD NOT BE FLUSHED, AND THE IMAGE REMAINED COMPLETELY BLACK THROUGHOUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENTS CONDITION WAS STABLE, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766352 ↗
• MalfunctionDec 9, 2025Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, THE CATHETER WAS BLOCKED AND THE LIQUID COULD NOT FLOW THROUGH IT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THE PATIENT CONDITION REMAINED STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760009 ↗
• MalfunctionDec 9, 2025Nonstandard Device; Device Displays Incorrect Message; Nonstandard Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION, AND IT WAS NOTED THAT THE OPTICROSS INTENDED FOR INTERVENTIONAL CARDIOLOGY WAS INCORRECTLY RECOGNIZED AS A PERIPHERAL INTERVENTION OPTICROSS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755076 ↗