OptiCross™ 6 HD H74939354080Recalls & reported problems

Summary

The FDA's MAUDE database contains 177 adverse event reports that list this exact device (DI 08714729960775), received between May 10, 2019 and Jan 2, 2026 — classified as 4 deaths, 20 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (103 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 177 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED VESSEL. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, AS THE IVUS CATHETER WAS INSERTED, IT SEIZED ON A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE PHYSICIAN GENTLY TUGGED THE WIRE BUT WAS UNABLE TO DISLODGE IT; HOWEVER, BOTH DEVICES WERE SAFELY REMOVED IN ONE PIECE, AND THERE WAS NO VISIBLE DAMAGE TO EITHER DEVICE. A NEW WIRE AND DIFFERENT TYPE OF IMAGING MODALITY WAS USED BUT THAT CATHETER ALSO FROZE ON THE WIRE DURING PULLBACK AND IT WAS THROUGH THE WIRE PROPERTIES MIGHT BE CAUSING THE ISSUE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THE PATIENT FULLY RECOVERED, AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23945224 ↗
• MalfunctionDec 31, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING AUTOMATIC PULLBACK, THE CATHETER SEIZED ON THE GUIDEWIRE AND THE WIRE WRAPPED UP INSIDE THE SHEATH OF THE OPTICROSS CATHETER. THE WHOLE SYSTEM WAS STUCK TOGETHER AND WAS REMOVED AS ONE UNIT. PROLONG THE PROCEDURE NO MORE IMAGING WAS NEEDED AND THE PROCEDURE CONTINUED TO COMPLETION. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934348 ↗
• MalfunctionDec 11, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER TIP BROKE WHILE ATTEMPTING AN INTRAVASCULAR ULTRASOUND IMAGING RUN. THE DEVICE WAS REMOVED IN ONE PIECE, AND AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782114 ↗
• MalfunctionDec 2, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD CATHETER WAS ADVANCED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. UPON WITHDRAWAL, THE WIRE APPEARED TO HAVE BEEN CAPTURED BY THE ROTATION OF THE TRANSDUCER AND WRAPPED AROUND THE CATHETER. BOTH DEVICES WERE REMOVED. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696448 ↗
• MalfunctionOct 30, 2025Entrapment of Device; Difficult to Advance; Material Deformation; Material Integrity Problem; Entrapment of Device; Difficult to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A SMALL, CALCIFIED, AND TORTUOUS DIAGONAL BRANCH. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WAS DIFFICULT TO ADVANCE. WHEN THE CATHETER WAS REMOVED, THE GUIDEWIRE WAS ALSO REMOVED BECAUSE THE CATHETER WAS WRAPPED AROUND THE GUIDEWIRE. A NEW GUIDEWIRE WAS USED TO COMPLETE THE INTERVENTION WITH NO FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS NOTED TO BE KINKED IN THE MONORAIL PORTION, AND THE TIP WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427277 ↗
• MalfunctionOct 21, 2025Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25 SEP 2025. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION; HOWEVER, POOR IMAGE QUALITY WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED. DEVICE ANALYSIS REVEALED THAT THE CATHETER WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352450 ↗
• MalfunctionOct 1, 2025Entrapment of Device; Mechanical Problem; Nonstandard Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Mechanical Problem; Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION. DURING THE PROCEDURE, THE CATHETER ROTATION LOCKED UP. THE CATHETER BECAME ENTANGLED WITH, AND WRAPPED AROUND, THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23197051 ↗
• DeathSep 23, 2025Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking; Device-Device Incompatibility; Difficult to Advance; Physical Resistance/Sticking

  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 ECHO

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Chest Pain; Perforation; Pericardial Effusion

  MAUDE report 23124687 ↗
• InjurySep 12, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Poor Visibility; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Poor Visibility

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER A SUCCESSFUL STENTING PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE IVUS CATHETER, RESISTANCE WAS ENCOUNTERED. PRESSURE WAS APPLIED TO WITHDRAW THE DEVICE, AND UPON REMOVAL, IT WAS NOTED THAT THE RADIOPAQUE MARKER AND DISTAL TIP HAD SHEARED OFF. THE LOCATION WAS INITIALLY UNCLEAR, AS THE MARKER WAS NOT VISIBLE ON FLUOROSCOPY. DURING CONTINUED INTERVENTION, THE RADIOPAQUE MARKER WAS OBSERVED IN THE LEFT MAIN CORONARY ARTERY. ATTEMPTS WERE MADE TO BALLOON DISTAL AND DRAG IT OUT WITH A SEMI-INFLATED BALLOON; HOWEVER, THE FINAL APPROACH WAS TO STENT IT INTO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23043361 ↗
• MalfunctionAug 22, 2025Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE LESION. DURING THE PROCEDURE, AS THE IVUS CATHETER WAS BEING INTRODUCED INTO THE BODY, IT BECAME TANGLED WITH THE GUIDEWIRE. REMOVAL OF THE CATHETER AND GUIDEWIRE WAS DIFFICULT. THE PROCEDURE COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877228 ↗
• MalfunctionJul 22, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT A CATHETER RECOGNITION ISSUE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE LESION. DURING PREPARATION, THE IVUS INTRAVASCULAR CORONARY CATHETER WAS INCORRECTLY REGISTERED AS A PERIPHERAL CATHETER ON THE AVVIGO II SYSTEM. THE USER PROCEEDED TO OBTAIN MEASUREMENTS USING THE CATHETER BUT WAS UNABLE TO VISUALIZE ARTERIAL DETAILS CLEARLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572178 ↗
• MalfunctionJul 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. DURING THE PROCEDURE, THE PHYSICIAN MANUALLY PULLED BACK THE CATHETER WHILE IMAGING. DURING THIS PROCESS, AN UNKNOWN WIRE BECAME WRAPPED AROUND THE 6FR OPTICROSS HD CATHETER. BOTH WIRE AND THE CATHETER WERE REMOVED FROM THE PATIENT DURING THE PERCUTANEOUS CORONARY INTERVENTION (PCI). THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE ORIGINAL METHOD. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572176 ↗
• MalfunctionJul 22, 2025Poor Quality Image; Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Material Deformation; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSIS WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED VESSEL. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR POST-STENT ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, NO IMAGE WAS SHOWN. UPON ASSESSMENT, THE CATHETER APPEARED TWISTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566172 ↗
• MalfunctionJul 11, 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 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WRAPPED AROUND THE UNKNOWN WIRE, MAKING IT IMPOSSIBLE TO REMOVE THE IVUS CATHETER WITHOUT ALSO REMOVING THE INTERVENTIONAL WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487491 ↗
• InjuryJun 27, 2025Poor Quality Image; Adverse Event Without Identified Device or Use Problem; Poor Quality Image; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Air Embolism; Bradycardia; Low Blood Pressure/ Hypotension; Non specific EKG/ECG Changes; Paralysis

  MAUDE report 22346147 ↗
• MalfunctionJun 11, 2025Entrapment of Device; Failure to Advance; Device-Device Incompatibility; Material Integrity Problem; Physical Resistance/Sticking; Entrapment of Device; Failure to Advance; Device-Device Incompatibility; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT WAS BEING TREATED FOR IN-STENT RESTENOSIS (ISR). THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, TWO WOLVERINE BALLOONS AND TWO SEMI-COMPLIANT BALLOONS WERE USED TO PRE-DILATE THE LESION. DESPITE MULTIPLE ATTEMPTS, THE OPTICROSS CATHETER COULD NOT CROSS THE LESION. AFTER STENT PLACEMENT, THE OPTICROSS AGAIN FAILED TO CROSS. WHEN THE OPTICROSS REACHED THE NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE CATHETER, THE NON- BSC GUIDEWIRE RETRACTED INTO THE PROXIMAL LAD. EXPERIENCING SIGNIFICANT RESISTANCE AND NOT WANTING TO EXERT FURTHER FORCE ON THE OPTICROSS WHICH HAD BECOME BONDED TO THE GUIDEWIRE, THE PHYSICIAN DECIDED TO REMOVE THE ENTIRE SYSTEM. ONCE OUTSIDE THE PATIENT, THE GUIDEWIRE WAS SUCCESSFULLY REMOVED FROM THE OPTICROSS, AND THE GUIDEWIRE WAS REMOVED FROM THE GUIDE CATHETER. MINOR DAMAGE WAS NOTED TO THE DISTAL TIP OF THE OPTICROSS AND THE AREA AROUND THE MONORAIL PORT FELT SHARP TO THE TOUCH. THE PROCEDURE WAS COM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183304 ↗
• InjuryMay 30, 2025Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE CATHETERIZATION LAB FOR AN INFERIOR WALL STEMI (ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) AND HAD TWO STENTS PLACED IN RIGHT CORONARY ARTERY. THE IVUS WAS USED AFTERWARDS TO ENSURE THE STENTS WERE PROPERLY PLACED AND DEPLOYED IN THE CORONARY ARTERY. WHEN IVUS IMAGING WAS DONE THE CATHETER COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE GUIDEWIRE AT THE SAME TIME. IT APPEARS THAT IVUS CATHETER GOT STUCK ON THE WIRE. IVUS CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AS A SINGLE UNIT. NO HARM TO PATIENT BUT COULD HAVE POTENTIALLY CAUSED HARD IF A GUIDEWIRE WAS STILL NEEDED.

  Patient problems: Myocardial Infarction; Non specific EKG/ECG Changes

  MAUDE report 22115303 ↗
• MalfunctionMay 12, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR THE ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER BECAME ENTANGLED WITH AN UNIDENTIFIED WIRE, MAKING IT IMPOSSIBLE TO REMOVE THE IVUS CATHETER WITHOUT ALSO REMOVING THE INTERVENTIONAL WIRE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006058 ↗
• MalfunctionMay 7, 2025Entrapment of Device; Poor Quality Image; Entrapment of Device; Poor Quality Image

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK ON NON-BOSTON SCIENTIFIC WIRE AFTER STARTING AUTO-PULLBACK. THE CATHETER AND WIRE WERE PULLED OUT TO REMOVE THEM FROM THE BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THE PATIENT IS STABLE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21976562 ↗
• MalfunctionMay 6, 2025Entrapment of Device; Difficult to Remove

  PATIENT WAS IN CATH LAB FOR INFERIOR WALL STEMI [ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION] AND HAD 2 STENTS PLACED IN RCA [RIGHT CORONARY ARTERY]. THE IVUS [INTRAVASCULAR ULTRASOUND] WAS USED AFTERWARDS TO ENSURE THE STENTS WERE PROPERLY PLACED AND DEPLOYED IN THE CORONARY ARTERY. WHEN IVUS IMAGING WAS DONE THE CATHETER COULD NOT BE REMOVED WITHOUT ALSO REMOVING THE GUIDEWIRE AT THE SAME TIME. IVUS CATHETER AND GUIDEWIRE WERE REMOVED TOGETHER, AS A SINGLE UNIT. IT APPEARS THAT IVUS CATHETER GOT STUCK ON THE WIRE. NO HARM TO PATIENT BUT COULD HAVE POTENTIALLY CAUSED HARD IF A GUIDEWIRE WAS STILL NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967920 ↗
• MalfunctionMay 2, 2025Entrapment of Device; Poor Quality Image; Entrapment of Device; Poor Quality Image

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK ON NON-BOSTON SCIENTIFIC WIRE AFTER STARTING AUTO-PULLBACK. THE CATHETER AND WIRE WERE PULLED OUT TO REMOVE THEM FROM THE BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THE PATIENT IS STABLE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951456 ↗
• MalfunctionApr 23, 2025Entrapment of Device; Device-Device Incompatibility; Physical Resistance/Sticking; Entrapment of Device; Device-Device Incompatibility; Physical Resistance/Sticking

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THET 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE LESION. A PATIENT UNDERGOING TREATMENT FOR CORONARY ARTERY DISEASE (CAD) WAS BEING EVALUATED USING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, WHICH WAS PREPARED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE (DFU) AND ADVANCED INTO THE TARGET VESSEL. DURING THE PROCEDURE, THE CATHETER COULD NOT CROSS AN IMPLANTED UNKNOWN STENT PROXIMAL TO THE LESION DUE TO SIGNIFICANT RESISTANCE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, THE NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE CAME OUT WITH IT. UPON INSPECTION, THE NON-BSC WIRE WAS FOUND TO BE BONDED TO THE OUTSIDE OF THE CATHETER AND COULD NOT BE SEPARATED. THE CATHETER AND NON-BSC WIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891363 ↗
• MalfunctionApr 23, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR AN INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER TWISTED ON ITSELF AND BECAME KNOTTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891274 ↗
• MalfunctionMar 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION (IVUS) OF THE TARGET LESION. DURING THE PROCEDURE, WHEN USING IVUS IT WRAPPED AROUND THE NON-BOSTON SCIENTIFIC GUIDEWIRE, AND THEY HAD TO TAKE EVERYTHING OUT OF THE BODY AND START OVER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721118 ↗
• MalfunctionMar 26, 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 A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698060 ↗