OptiCross H749518120Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 08714729841531), received between Aug 30, 2018 and Feb 9, 2026 — classified as 3 deaths, 7 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300118 ↗
• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OPTICROSS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300117 ↗
• MalfunctionFeb 9, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT ENTRAPPED AIR OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS). DURING PREPARATION, THE INITIAL IMAGE APPEARED NORMAL, BUT SHORTLY AFTERWARD BUBBLES WERE OBSERVED AND THE IMAGE TURNED BLACK AND BECAME NON VIEWABLE. THE CATHETER WAS DIFFICULT TO FLUSH. THREE ATTEMPTS WERE MADE TO FLUSH THE CATHETER TO REMOVE AIR, BOTH INSIDE AND OUTSIDE THE PATIENT, BUT AIR CONTINUED TO APPEAR DURING PULLBACK. RESISTANCE WAS ALSO NOTED WHEN ATTEMPTING TO PUSH FLUID THROUGH THE SYRINGES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300115 ↗
• MalfunctionFeb 5, 2026No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR INSIDE THE CATHETER. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER TAKING THREE FLUSHING ATTEMPTS BEFORE THE DEVICE WAS SUCCESSFULLY FLUSHED, THE CATHETER WAS INSERTED INTO THE PATIENT. THERE WERE BLACK VISUALS AND BUBBLES PRESENT DURING THE RUN. ANOTHER FLUSHING WAS ATTEMPTED, HOWEVER THIS RESULTED IN NO VISUALS. THE CATHETER WAS REMOVED FROM THE PATIENT, AND ANOTHER OPTICROSS CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268437 ↗
• MalfunctionFeb 3, 2026Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE FLUSHING THE CATHETER, AND THE PHYSICIAN WAS UNABLE TO ELIMINATE THE AIR. A SECOND DEVICE WAS USED BUT DID NOT SUCCEED IN FLUSHING AS WELL. AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252947 ↗
• MalfunctionFeb 3, 2026Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHILE FLUSHING THE CATHETER, AND THE PHYSICIAN WAS UNABLE TO ELIMINATE THE AIR. A SECOND DEVICE WAS USED BUT EXHIBITED THE SAME ISSUE. A THIRD DEVICE OF THE SAME TYPE WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250666 ↗
• MalfunctionFeb 3, 2026Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, RESISTANCE WAS ENCOUNTERED WHILE FLUSHING THE CATHETER, AND THE PHYSICIAN WAS UNABLE TO ELIMINATE THE AIR. A SECOND DEVICE WAS USED BUT EXHIBITED THE SAME ISSUE. A THIRD DEVICE OF THE SAME TYPE WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO COMPLICATIONS REPORTED. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250605 ↗
• MalfunctionDec 9, 2025Difficult to Flush; Material Deformation; Material Integrity Problem; Air/Gas in Device; Difficult to Flush; Material Deformation; Material Integrity Problem; Air/Gas in Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION. DURING PREPARATION, WHILE FLUSHING THE CATHETER, IT ABNORMALLY INFLATED AT THE CONNECTOR. A VIDEO SHOWS A BALLOON-LIKE EXPANSION FORMING WHEN ATTEMPTING TO CLEAN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760800 ↗
• InjuryNov 24, 2025No Display/Image; Difficult to Flush; Air/Gas in Device; No Display/Image; Difficult to Flush; Air/Gas in Device

  IT WAS REPORTED THAT AN IMAGING ISSUE AND PATIENT COMPLICATIONS OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, NO IMAGE WAS VISIBLE DURING IVUS, AND RESISTANCE WAS NOTED DURING FLUSHING. THE IVUS DEVICE APPEARED TO BE ENTRAINING AIR INTO THE CATHETER, WHICH RESULTED IN ST ELEVATION AND SLOW REFLOW DOWN THE CORONARY ARTERY DUE TO PROBABLE AIR EMBOLIZATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes; Reduced Blood Flow

  MAUDE report 23638228 ↗
• MalfunctionNov 12, 2025Device Displays Incorrect Message; Connection Problem; Device Displays Incorrect Message; Connection Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. THE PACKAGING INDICATED IT WAS AN OPTICROSS 40 MHZ CATHETER; HOWEVER, UPON CONNECTION, THE SYSTEM RECOGNIZED IT AS AN OPTICROSS 18 (30 MHZ) CATHETER INTENDED FOR PERIPHERAL USE. THE PROCEDURE WAS CONTINUED USING THE ORIGINAL DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WITH 80 - 90% STENOSED WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531278 ↗
• MalfunctionNov 10, 2025Leak/Splash; Poor Quality Image; Material Deformation; Material Integrity Problem; Leak/Splash; Poor Quality Image; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, SOME OF THE SALINE SOLUTION GOT INTO THE MOTOR DRIVE UNIT SO THAT THE IMAGE WAS OF VERY LOW QUALITY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515686 ↗
• MalfunctionOct 23, 2025No Display/Image; Image Display Error/Artifact; Nonstandard Device; Detachment of Device or Device Component; No Display/Image; Image Display Error/Artifact; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER FRACTURED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER BROKE AT THE PROXIMAL PART, AND NO IMAGE COULD BE OBTAINED. A DIFFERENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372177 ↗
• MalfunctionOct 23, 2025No Display/Image; Nonstandard Device; Detachment of Device or Device Component; No Display/Image; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CATHETER FRACTURED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER BROKE AT THE DISTAL PART, AND NO IMAGE COULD BE OBTAINED. A DIFFERENT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372176 ↗
• MalfunctionJul 16, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER BECAME COILED AROUND THE CORONARY WIRE AFTER EXITING THE VESSEL, LEADING TO A MALFUNCTION AND DEFECT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525504 ↗
• MalfunctionApr 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 50-70 % STENOSED TARGET LESION WAS LOCATED IN THE MINIMAL TORTUOUS AND 20-30 % CALCIFIED VESSEL IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE OPTICROSS CATHETER WAS PREPARED ACCORDING TO PROPER STEPS. HOWEVER, THE PHYSICIAN NOTED FROM THE ANGIOGRAM THAT THE TIP OF THE IVUS CATHETER WAS SEMI-DETACHED FROM THE GUIDEWIRE EXIT PORT. THE PHYSICIAN THEN PROCEEDED TO TAKE OUT THIS CATHETER. THE PROCEDURE COMPLETED USING ANOTHER OF THE SAME DEVICE. THE PATIENT WAS ALRIGHT AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882706 ↗
• DeathMar 20, 2025Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEATH HAD OCCURRED. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER BECAME TANGLED WITH STENT STRUTS OR THE GUIDEWIRE AND WAS TRAPPED. IT TOOK MORE THAN THREE HOURS TO REMOVE AND COMPLETE THE PROCEDURE. THE PATIENT PASSED AWAY 1.5 HOURS LATER, PROBABLY DUE TO ISCHEMIA DURING THE PROCEDURE.

  Patient problems: Ischemia

  MAUDE report 21653878 ↗
• MalfunctionFeb 21, 2025Failure to Advance; Detachment of Device or Device Component; Material Deformation; Failure to Advance; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESIONS. THE OPTICROSS CATHETER WAS FIRST USED IN THE LCX AND A STENT WAS FINELY DEPLOYED. THE OPTICROSS CATHETER WAS THEN INSERTED TO LAD. THE OPERATOR FELT THE CATHETER WAS STUCK WHEN CROSSING THE LESION BUT CONTINUED TO APPLY FORCE UNTIL THE CATHETER BENT AND SNAPED. THE DEVICE WAS REMOVED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21434914 ↗
• InjuryNov 15, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT AN ST ELEVATION OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING AN IVUS CATHETER PULLBACK, IMAGING WAS LOST AS THEY NEARED THE PROXIMAL VESSEL. DESPITE ATTEMPTS TO FLUSH THE CATHETER, THE IMAGE WAS NOT RESTORED. THE PATIENT SIMULTANEOUSLY DEVELOPED SIGNIFICANT ST ELEVATION ON THE ECG, PROMPTING THEM TO REMOVE THE CATHETER. AFTER REMOVAL, THE PATIENT WAS STABILIZED AND THE ST ELEVATION GRADUALLY SUBSIDED. THE INTRODUCTION OF AIR FROM THE DEVICE OR PROCEDURE CAUSED OR CONTRIBUTED TO THE PATIENT'S COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ORIGINAL METHOD OR DEVICE. THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 20695659 ↗
• MalfunctionNov 7, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22 OCT 2024. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A NON-BOSTON SCIENTIFIC (NON-BSC) 3.5 6F GUIDE CATHETER WAS PLACED. AND THE OPTICROSS IMAGING CATHETER WAS ADVANCED OVER A NON-BSC GUIDEWIRE FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE LESION. THE CATHETER KINKED WHILE ADVANCING INTO THE LESION AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE IMAGING WINDOW WAS TWISTED, AND THE SHEATH WAS KINKED AND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20630717 ↗
• MalfunctionAug 15, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTANGLED WITH THE CATHETER. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE GUIDEWIRE WITHIN THE CATHETER SHEATH TWISTED AND EXTERNALIZED OUTSIDE THE CATHETER. THE DEVICE WAS REMOVED, AND ANOTHER OPTICROSS IMAGING CATHETER WAS ADVANCED. THE SECOND OPTICROSS IMAGING CATHETER ENCOUNTERED THE SAME ISSUE WITH THE GUIDEWIRE. A THIRD IMAGING CATHETER WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19996003 ↗
• MalfunctionAug 15, 2024Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTANGLED WITH THE CATHETER. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE GUIDEWIRE WITHIN THE CATHETER SHEATH TWISTED AND EXTERNALIZED OUTSIDE THE CATHETER. THE DEVICE WAS REMOVED, AND ANOTHER OPTICROSS IMAGING CATHETER WAS ADVANCED. THE SECOND OPTICROSS IMAGING CATHETER ENCOUNTERED THE SAME ISSUE WITH THE GUIDEWIRE. A THIRD IMAGING CATHETER WAS THEN USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19995946 ↗
• MalfunctionJul 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN THE DEVICE WAS BEING WITHDRAWN A SEPARATION OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION POST PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750493 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE 80% TARGET LESION. DURING THE PROCEDURE, UPON REMOVAL OF THE DEVICE, THE DISTAL PART OF THE IVUS CATHETER DETACHED AT 28CM DISTAL. THIS PART BECAME TRAPPED IN THE Y KEY THAT CONNECTS TO THE GUIDE CATHETER HUB. THE Y KEY WAS REMOVED WHERE THE DETACHED PART WAS TRAPPED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENTS BODY AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163437 ↗
• MalfunctionMar 28, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHEN IMAGING WAS STARTED, THE SHAFT WAS DETACHED AND THE CATHETER WAS COILED TOGETHER OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000642 ↗
• MalfunctionMar 28, 2024Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS PERFORMED ON 04MAR2024. IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING PREPARATION, UPON FLUSHING, THEY DISCOVERED FLUID LEAKAGE FROM THE MIDSECTION OF THE MID MONORAIL SHAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. DEVICE ANALYSIS SHOWED THAT THE IMAGING WINDOW WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18999927 ↗