OptiCross H749518110Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729847878), received between Jan 11, 2017 and Aug 22, 2025 — classified as 1 death, 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE UNKNOWN WIRE BECAME WRAPPED AROUND THE CATHETER AND GOT STUCK. THE ENTIRE ASSEMBLY WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877106 ↗
• MalfunctionDec 1, 2023Detachment 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 CORONARY ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING CROSSING THE LESION, THE TIP OF THE CATHETER BROKE OFF. THE DEVICE WAS REMOVED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246268 ↗
• MalfunctionNov 7, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER FOLDED IN ITSELF AND COULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088589 ↗
• MalfunctionJun 6, 2023Material Deformation; Material Integrity Problem; Material Twisted/Bent; Material Deformation; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT CATHETER TWIST AND FRACTURE OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. NO FRICTION WAS NOTED WHEN LOADING THE CATHETER BUT AFTER IMAGING WAS STARTED, RESISTANCE OCCURRED. UPON PULLBACK THE CATHETER BECAME WRAPPED AROUND THE 0.014 GUIDEWIRE AND IMAGING STOPPED SINCE THE CATHETER WAS NO LONGER ABLE TO ROTATE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER AS A UNIT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE CATHETER WAS NOTED TO HAVE MULTIPLE KINKS AT THE DISTAL EXCHANGE AREA AND PROXIMAL PORTION AT THE CONE AND MULTIPLE FRACTURES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071953 ↗
• MalfunctionMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20APR2023. THE OPTICROSS IMAGING CATHETER WAS RETURNED WITHOUT ANY ALLEGATION OF A DEVICE ISSUE. HOWEVER, DEVICE ANALYSIS REVEALED ENTRAPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891358 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AIR EMBOLISM OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR- INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. IMMEDIATELY FOLLOWING IVUS AND REMOVAL OF THE CATHETER, MULTIPLE, SIZABLE AIR EMBOLI WERE NOTICED AFTER ST CHANGES. ADENOSINE WAS ADMINISTERED, AND THE PATIENT CONDITION RESOLVED. THE PATIENT FULLY RECOVERED.

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

  MAUDE report 16765629 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM OCCURRED. THE 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 INITIAL IVUS RUN, THE PATIENT EXPERIENCED ST CHANGES AND SLOW FLOW ACCOMPANIED BY MODERATE AIR EMBOLI. AIR EMBOLI WERE VISUALLY PRESENT DURING THE IVUS RUN AND AFTER THE OPTICROSS CATHETER WAS REMOVED. ADENOSINE WAS ADMINISTERED AND A BALLOON PUMP WAS INSERTED. THE LAD LESION WAS SHOCK WAVED AND STENTED, RESULTING IN IMPROVED FLOW AND ST RETURNING TO BASELINE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WENT TO THE CVICU FOR OBSERVATION BUT WAS OTHERWISE STABLE. THE PATIENT FULLY RECOVERED AND WAS DISCHARGED.

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

  MAUDE report 16732862 ↗
• MalfunctionApr 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DISTAL PART OF THE CATHETER BROKE LIKE IT WAS EXPLODED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16713610 ↗
• MalfunctionJun 29, 2022Poor Quality Image; Detachment of Device or Device Component; Poor Quality Image; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE THE IMAGE WENT DARK AND WHEN THE CATHETER WAS REMOVED IT WAS FOUND BROKEN AT THE LAPJOINT. THE DRIVE SHAFT APPEARED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854314 ↗
• MalfunctionJun 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. DURING A PROCEDURE INVOLVING AN OPTICROSS IMAGING CATHETER, THE CATHETER BROKE INTO MULTIPLE SECTIONS. 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 14804300 ↗
• MalfunctionApr 28, 2022Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE OPTICROSS IMAGING CATHETER WAS INTRODUCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. THE CATHETER GOT BENT AT THE HEMOSTASIS VALVE LOCATION. THE MOTOR DRIVE CONTINUED TO SPIN AND WOULD NOT SHUT OFF. WHEN THE PHYSICIAN TRIED TO REMOVE THE CATHETER FROM THE GUIDEWIRE, THERE WAS TREMENDOUS RESISTANCE. THE CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER AND UPON REMOVAL IT WAS APPARENT THAT THE CATHETER HAD WRAPPED THE WIRE AROUND ITSELF. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246294 ↗
• InjuryApr 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR A COMPLEX PERCUTANEOUS CORONARY INTERVENTION. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION AND WAS REMOVED WITH NO ISSUES. LATER IN THE CASE, THE SAME CATHETER WAS ADVANCED TO PERFORM IVUS AGAIN AND DURING REMOVAL THE TIP SHEARED OFF. TWO DIFFERENT MICRO SNARES WERE USED BUT REMOVAL ATTEMPTS WERE UNSUCCESSFUL. ALL DEVICES WERE THEN REMOVED FROM THE PATIENT AND THE ENTIRE SHEARED PIECE WAS RETRIEVED SUCCESSFULLY FROM THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14031150 ↗
• MalfunctionFeb 9, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE MILDLY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION. DURING AN ATTEMPT TO REMOVE THE DEVICE OVER THE GUIDEWIRE, THE WIRE GOT STUCK IN THE CATHETER. THE GUIDE CATHETER, GUIDEWIRE, AND OPTICROSS WERE ALL REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501945 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AIR EMBOLISM OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT MAIN. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AT SOME POINT IT WAS NOTICED THAT AN AIR EMBOLISM WENT DOWN THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT BEGAN EXPERIENCING CHEST PAIN AND WAS HAVING DIFFICULTY BREATHING. THE PATIENT ALSO EXPERIENCED VENTRICULAR FIBRILLATION. THE PATIENT WAS PUT ON 100% OXYGEN AND A DOPAMINE DRIP. A NON-BOSTON SCIENTIFIC ASPIRATION CATHETER WAS USED TO REMOVE THE AIR EMBOLISM AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: Chest Pain; Embolism/Embolus; Ventricular Fibrillation

  MAUDE report 13261075 ↗
• MalfunctionNov 8, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS RENAL ARTERY. THE OPTICROSS US IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER STUCK TO THE GUIDEWIRE AND CAUSED IT TO KINK NEAR THE TIP, EXIT PORT. THE DEVICE REMAINED INTACT BUT HAD TO BE REMOVED TOGETHER WITH THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12774693 ↗
• InjurySep 30, 2021Difficult to Flush; Difficult to Flush

  IT WAS REPORTED THAT AIR EMBOLISM AND NO FLOW OCCURRED. DURING A PROCEDURE INVOLVING AN OPTICROSS US IMAGING CATHETER, THE TECHNICIAN WAS FLUSHING THE DEVICE AND AIR WAS INJECTED INTO THE VESSEL. THE PATIENT WAS UNSTABLE FOR A FEW MINUTES WITH NO FLOW. THE VESSEL WAS REOPENED AND THE PATIENT WAS FINE.

  Patient problems: Air Embolism; Obstruction/Occlusion

  MAUDE report 12553729 ↗
• MalfunctionApr 27, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE BECAME STUCK IN THE ARTERY. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR A POST STENT RUN. THE DEVICE GOT STUCK IN THE ARTERY AND A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS ADVANCED AND NITRO GIVEN. THE OPTICROSS WAS REMOVED WITHOUT PATIENT COMPLICATIONS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735630 ↗
• MalfunctionApr 9, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A CATHETER STUCK IN STENT OCCURRED. FOLLOWING IMPLANTATION OF A STENT, THE OPTICROSS IMAGING CATHETER WAS INTRODUCED FOR LESION VISUALIZATION. DURING PULLBACK OF THE CATHETER, THE TIP BECAME STUCK ON THE DISTAL EDGE OF THE NEWLY PLACED STENT AND THE CATHETER WAS UNABLE TO BE REMOVED FROM THE PATIENT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11642842 ↗
• MalfunctionMar 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. AN OPTICROSS US IMAGING CATHETER WAS INTRODUCED TO VIEW THE TARGET LESION. DURING WITHDRAWAL, THE CATHETER BROKE AND WAS REMOVED USING THE GUIDE EXTENSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11398698 ↗
• MalfunctionJun 25, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE STERILITY OF THE DEVICE WAS COMPROMISED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE STERILE IVUS BAG HAD A HAIR ON IT. A NEW IVUS HAD TO BE OPENED JUST FOR THE PROTECTIVE STERILE BAG. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10197432 ↗
• MalfunctionJun 12, 2020Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20MAY2020. IT WAS REPORTED THAT LOST IMAGE OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, THE PHYSICIAN PREPPED AND TESTED OUTSIDE THE BODY AND IT WAS WORKING. THEY WENT INTO THE BODY AND IT WAS STILL WORKING. THEY GAVE ANOTHER FLUSH AND WHEN THEY WENT TO RECORD THE IMAGE WAS GONE AND IT NO LONGER WORKED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS NOTED THE IMAGING WINDOW WAS PARTIALLY DETACHED FROM THE LAPJOINT SECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148571 ↗
• MalfunctionDec 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE TO VIEW THE TARGET LESION. DURING A PROCEDURE WITH THE IVUS, IT WAS PREPPED WRONG HOWEVER IT BROKE DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9521766 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ST ELEVATION OCCURRED. AN OPTICROSS IMAGING CATHETER WAS USED TO VIEW THE LESION. THE ST RATES WERE FINE BEFORE THE IVUS RUN. HOWEVER, DURING THE PROCEDURE, WHEN THE CATHETER WAS INSERTED THEY NOTICED THAT THE PATIENTS ST ELEVATION INCREASED. WHEN THE CATHETER WAS REMOVED, THE ST RATES WENT BACK TO A NORMAL LEVEL. THE IVUS WAS SUCCESSFULLY COMPLETED. THERE WAS NOTHING WRONG WITH THE IMAGE AND THERE WAS NO INTERVENTION PERFORMED DURING THE CASE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE USED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: ST Segment Elevation

  MAUDE report 8739455 ↗
• MalfunctionApr 23, 2019Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, WHEN THEY WERE GOING IN WITH THE DEVICE INSIDE THE PATIENT'S BODY, IT WAS NOTED THAT THE DEVICE BENT AND BROKE. THE PROCEDURE WAS COMPLETED WITH A NON BSC DEVICE. NO HARM TO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541428 ↗
• MalfunctionAug 31, 2018Entrapment of Device; Poor Quality Image; Positioning Problem; Entrapment of Device; Poor Quality Image; Positioning Problem

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS CIRCUMFEX ARTERY. A SYNERGY STENT WAS IMPLANTED. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR USE. DURING PROCEDURE, AFTER ONE INTRAVASCULAR ULTRASOUND (IVUS) RUN WAS PERFORMED, A SECOND RUN WAS ATTEMPTED BUT WAS NOT ABLE TO ACQUIRE AN IMAGE. THE SHAFT OF THE CATHETER BEGAN TO SHAKE. IVUS WAS STOPPED AND THEN THE CATHETER WAS VERY DIFFICULT TO REMOVE FROM THE PATIENT'S BODY. THE OPTICROSS IMAGING CATHETER WAS ABLE TO BE REMOVED INTACT. HOWEVER, THE TRANSDUCER WOULD NOT ADVANCE OR RETRACT WITHIN THE SHEATH AFTER REMOVAL. EXAMINATION WAS PERFORMED UNDER FLUOROSCOPY AND DETACHED TIP OF A NON-BSC GUIDEWIRE WAS OBSERVED IN THE ARTERY. IT WAS SEEN UNDER FLUOROSCOPY THAT THE TIP OF THE NON-BSC GUIDEWIRE BECAME ENTRAPPED WITHIN THE IMPLANTED SYNERGY STENT. NO DAMAGE WAS NOTED ON THE SYNERGY STENT. THE PATIENT WAS STABLE; HOWEVER, THE PATIENT WENT TO SURGERY FOR RETRIEVAL OF THE DETACHED TIP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7839396 ↗