OptiCross 6 H7495181160Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729904762), received between Dec 19, 2017 and Oct 1, 2024 — classified as 1 death, 5 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (19 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Entrapment of Device; Entrapment of Device

  IT WAS REPORTED VIA MEDWATCH 3600840000-2024-8101 THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. THE IVUS CATHETER BEGAN TO SPIN THE NON-BOSTON SCIENTIFIC GUIDEWIRE. BOTH DEVICES WERE REMOVED TOGETHER BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO COMPLICATIONS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343993 ↗
• MalfunctionSep 10, 2024

  MIDDLE AGED FEMALE WITH RECENT ONSET OF CHEST PAIN. PROCEDURE: L AND R CARDIAC CATHETERIZATION WITH PERCUTANEOUS INTERVENTION. THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER STARTED TO SPIN THE RUN THROUGH WIRE. BOTH WERE REMOVED TOGETHER. A NEW ONE OF EACH (IVUS AND RUN THROUGH) USED FOR PROCEDURE WITHOUT KNOWN INJURY. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER), WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179732 ↗
• InjurySep 4, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE GREATER THAN 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT CIRCUMFLEX ARTERY (LCX). THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. AFTER A RUN WAS PERFORMED, AN ATTEMPT WAS MADE TO REMOVE THE CATHETER, BUT IT REMAINED HUNG UP IN THE LEFT MAIN. SEVERAL ATTEMPTS WERE MADE TO PULL BACK THE DEVICE, BUT IT WOULD NOT COME BACK INTO THE 6F GUIDE CATHETER. AN ATTEMPT WAS THEN MADE TO REMOVE THE ENTIRE SYSTEM, INCLUDING THE WIRE, BUT A SNAP WAS HEARD IN THE IVUS CATHETER. THE MAJORITY OF THE OPTICROSS 6 WAS REMOVED, BUT WHEN FLUOROSCOPY WAS PERFORMED, THE RADIOPAQUE PORTION OF THE CATHETER COULD BE VISUALIZED IN THE LEFT MAIN, STILL ON THE WIRE. THE DEVICE FRAGMENT COULD NOT COME BACK ANY FURTHER THAN THE DISTAL LEFT MAIN. ANOTHER WIRE WAS THAN RUN NEXT TO THE DETACHED FRAGMENT AND A BALLOON WAS SENT DOWN THE VESSEL IN A FAILED ATTEMPT TO PIN THE FRAGMENT FOR REMOVAL. THE DECISION WAS MADE TO INSTEAD STENT THE DETACHED FRAGMENT, BUT SINCE DIFFERENT EQUIPMENT WAS NEEDED TO COMPLETE THE PR

  Patient problems: Foreign Body In Patient

  MAUDE report 20135786 ↗
• MalfunctionJul 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE PATIENT PRESENTED WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WITH HISTORY OF CHEST PAIN AND POSITIVE STRESS TEST. THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. DURING THE PTCA, THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER WRAPPED AROUND WIRE. THE ENTIRE SYSTEM HAD TO BE REMOVED (WIRE, IVUS, GUIDE CATHETER, AND SHEATH.) NO KNOWN HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669627 ↗
• MalfunctionJun 11, 2024

  ELDERLY MALE WITH HISTORY OF CHEST PAIN AND POSITIVE STRESS TEST. PROCEDURE: PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY). DURING THE PTCA. THE IVUS (INTRAVASCULAR ULTRASOUND) CATHETER WRAPPED AROUND WIRE. THE ENTIRE SYSTEM HAD TO BE REMOVED. (WIRE, IVUS, GUIDE CATHETER, AND SHEATH.)NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508894 ↗
• MalfunctionDec 28, 2023Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT IMAGING WINDOW FAILURE TO ROTATE OCCURRED. THE OPTI CROSS IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AFTER THE CATHETER WAS PREPARED, THE MOTOR DRIVE UNIT WAS STARTED BUT THE INTRAVASCULAR ULTRASOUND DRIVE SHAFT DID NOT SPIN. A FEW RECONNECTIONS WERE DONE BUT THE DEVICE STILL DID NOT SPIN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE IMAGING WINDOW WAS TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18411521 ↗
• InjuryDec 19, 2023Retraction Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Retraction Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COMPLICATIONS OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AN OPTICROSS IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION AND THE CATHETER AND THE SLED WERE PREPARED APPROPRIATELY. THE CATHETER WAS INSERTED AND WHEN PULLBACK WAS ATTEMPTED, THE CATHETER WOULD NOT PULLBACK. THE MOTOR DRIVE UNIT WAS REMOVED AND REINSERTED INTO THE SLED, BUT PULLBACK WOULD NOT START. A NEW SLED WAS OPENED AND PRE AND POST IVUS FOR THE LAD WERE PERFORMED. THE CIRCUMFLEX ARTERY WAS ALSO DISEASED AND WAS WIRED. WHEN THE OPTICROSS CATHETER WAS INSERTED, THE TRANSDUCER WOULD NOT ADVANCE OUT OF THE GUIDE CATHETER. THE PATIENT STARTED TO HAVE CHEST PAIN, SO THE CATHETER WAS REMOVED, AND AN ANGIOGRAM WAS TAKEN. AIR EMBOLISM WAS OBSERVED, AND THE LAD HAD NO BLOOD FLOW. THE PATIENT WAS GIVEN VASODILATORS AND WITHIN A FEW MINUTES THE LAD WAS OPEN, AND THE PATIENT RECOVERED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT IVUS. AFTER THE CASE, THE CATHETER WAS INSPECTED, AND IT WAS NOTED THAT A PART NEAR THE HUB WAS BROKEN WHICH STOPPED THE SLED F

  Patient problems: Air Embolism; Chest Pain; Reduced Blood Flow

  MAUDE report 18358579 ↗
• MalfunctionNov 22, 2023Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem; Unable to Obtain Readings; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2023. IT WAS REPORTED THAT VISUALIZATION ISSUES OCCURRED. THE OPTICROSS HD IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION, BUT THE IMAGE WAS COMPLETELY BLACK AFTER MULTIPLE FLUSHES AND RECONNECTIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE IMAGING WINDOW AND IMAGING CORE WERE TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18193877 ↗
• MalfunctionOct 3, 2023Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. AN OPTICROSS 6 CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. WHEN THE CATHETER WAS BEING PULLED BACK AFTER THE IVUS RUN WAS COMPLETED, THE GUIDEWIRE WAS STUCK IN THE LUMEN. THE ENTIRE GUIDEWIRE WAS PULLED FROM THE VESSEL AND BECAME DAMAGED. THE TIP OF THE CATHETER WAS ALSO NOTED TO BE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17861763 ↗
• MalfunctionAug 4, 2023

  ELDERLY FEMALE WITH HISTORY OF CAD (CORONARY ARTERY DISEASE). PROCEDURE: HEART CATH WITH PCI (PERCUTANEOUS CORONARY INTERVENTION). THE MOTOR MALFUNCTIONED AND WOULD NOT WORK. ANOTHER ONE USED WITHOUT INCIDENT. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17457973 ↗
• MalfunctionJul 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DEVICE TWIST OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER WRAPPED ITSELF AROUND THE GUIDEWIRE. THE CATHETER AND WIRE HAD TO BE REMOVED TOGETHER AS A UNIT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344242 ↗
• MalfunctionApr 27, 2023No Display/Image

  EARLY 70¿S MALE WITH HISTORY OF CHRONIC KIDNEY DISEASE, DIABETES, HYPERTENSION, CORONARY ARTERY DISEASE AND SEVERE AORTIC STENOSIS. PROCEDURE: DIAGNOSTIC HEART CATH WITH PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. IVUS CATHETER WOULD NOT DISPLAY IMAGE (BLACK) UPON ENTERING INTO THE CATHETER. TROUBLE SHOOTED BY REMOVING CATHETER AND FLUSHED- STILL NO IMAGE. IVUS REMOVED AND ANOTHER ONE USED WITH GOOD IMAGES. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16822774 ↗
• MalfunctionApr 25, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT A CATHETER TWIST OCCURRED. AN OPTICROSS 6 IMAGING CATHETER WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION. DURING INSERTION, WHEN ADVANCING DOWN THE VESSEL, THE INTRAVASCULAR ULTRASOUND CATHETER KINKED AND TWISTED AND THERE WERE KINKS AND TWISTS IN THE DRIVE SHAFT. THE MDU WAS TURNED ON AND RUNNING WHEN THE ISSUE HAPPENED. 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 16808988 ↗
• MalfunctionApr 13, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED VIA MEDWATCH 3600840000-2023-8023 THAT CATHETER TWISTING OCCURRED. THE PATIENT PRESENTED WITH NEW ONSET OF SHORTNESS OF BREATH. THE OPTICROSS 6 IMAGING CATHETER WAS INTRODUCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. WHILE ADVANCING IN THE LESION FOR THE FIRST TIME, THE CATHETER FOLDED BACK ON ITSELF SEVERAL TIMES CAUSING TWISTS AND KINKS WHICH MADE THE CATHETER NONFUNCTIONAL. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER DEVICE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735049 ↗
• MalfunctionApr 10, 2023Entrapment of Device; Poor Quality Image; Physical Resistance/Sticking; Entrapment of Device; Poor Quality Image; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CIRCUMFLEX ARTERY. AFTER A 190 NON-BOSTON SCIENTIFIC GUIDEWIRE WAS PLACE, THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR INTRAVASCULAR ULTRASOUND (IVUS) EXAMINATION OF THE TARGET LESION. ONCE THE CATHETER WAS CLOSE TO THE ARTERY, IMAGING WAS TURNED ON. THE PHYSICIAN FELT SOME RESISTANCE WITH THE IVUS WIRE THAT HAD A KNUCKLE ON IT AND CAME BACK A BIT. WHILE THE CATHETER WAS IN USE, THERE WERE ISSUES WITH IMAGING. THE PHYSICIAN REMOVED THE CATHETER AND NOTICED THERE WAS WIRE WRAP UP. A NEW IVUS CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16710288 ↗
• MalfunctionMar 28, 2023Material Twisted/Bent

  MID 70¿S MALE WITH HISTORY OF CORONARY ARTERY DISEASE AND SMOKING. NEW ONSET OF SHORTNESS OF BREATH. PROCEDURE: DIAGNOSTIC HEART CATH AND BALLOON ANGIOPLASTY AND PERCUTANEOUS INTERVENTION X 2. WHEN GOING INTO THE VESSEL THE FIRST TIME, CATHETER FOLDED BACK ON ITSELF SEVERAL TIMES CAUSING TWISTS AND KINKS DEEMING NONFUNCTIONING. NO KNOWN HARM TO PATIENT. DEVICE REMOVED AND ANOTHER ONE USED. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16627027 ↗
• MalfunctionMay 20, 2022Connection Problem

  ELDERLY MALE WITH RECENT HISTORY OF CHEST PAIN AND INFERIOR ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION. PROCEDURE: LEFT HEART CATH WITH PCI OF PROXIMAL RIGHT CORONARY. PROBLEM; CENTRAL CONSOLE WAS UNABLE TO CONNECT. ANOTHER DEVICE USED, NO KNOWN HARM TO PATIENT. THIS IS REPORT #3 FOR THE SAME PRODUCT. THERE IS ALSO A NUMBER 4, 5 AND 6. BOSTON SCIENTIFIC REP IS AWARE AND GOING TO REPLACE ALL 6 PRODUCTS. PLEASE REFER TO 1ST 2 REPORTED TO MEDSUN AS (B)(4) AND (B)(4). MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14456416 ↗
• InjuryMay 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON CALCIFIED RIGHT CORONARY ARTERY. THE OPTICROSS 6 IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. AS THE DEVICE WAS BEING REMOVED WITH MILD TO MODERATE TENSION A POP WAS FELT AND IT WAS NOTED THAT THE TIP OF THE DEVICE WAS SEPARATED FROM THE SHAFT NEAR THE RAPID EXCHANGE PORT. THE TIP REMAINED ON THE WIRE. THE WIRE AND GUIDE WERE CAREFULLY REMOVED FROM THE VESSEL WITH THE DETACHED TIP NOT MOVING. A SECOND 0.014 WIRE WAS USED TO WRAP THE DISTAL PORTION OF THE WIRES TOGETHER TRAPPING THE OPTICROSS TIP ON THE FIRST WIRE. BOTH WIRES WERE THEN REMOVED WITH THE TIP SECURED TO THE FIRST WIRE. THERE WERE NO PATIENT COMPLICATIONS. FINAL ANGIOGRAPHY REVEALED TIMI 3 FLOW WITH 20% DISTAL RESIDUAL AND A TREATED MID VESSEL DISSECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274219 ↗
• MalfunctionApr 27, 2022Device Difficult to Setup or Prepare

  ELDERLY MALE WITH HISTORY OF HYPERTENSION, DIABETES MELLITUS (DM) AND POST COVID. RECENT INCREASED SHORTNESS OF BREATH BROUGHT TO ED AND THEN ADMITTED. PROCEDURE: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. UPON REMOVAL OF CATHETER FROM THE PACKAGE, THE SCRUBBER WAS UNABLE TO DISENGAGE, UNABLE TO PREP CATHETER. NOT USED ON THE PATIENT. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218016 ↗
• MalfunctionApr 19, 2022Break

  ELDERLY MALE WITH HISTORY OF ATHEROSCLEROTIC HEART DISEASE. PROCEDURE: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE DEVICE BROKE WHEN IN CONTACT WITH CALCIUM DISTORTED PROTEIN. MANUFACTURER RESPONSE FOR CATHETER, ULTRASOUND, INTRAVASCULAR, OPTICROSS 6 (PER SITE REPORTER). WILL OBTAIN.

  Patient problems: Insufficient Information

  MAUDE report 14140828 ↗
• InjuryNov 3, 2021Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT VESSEL OCCLUSION OCCURRED. THE OPTICROSS IMAGING CATHETER WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. HOWEVER, WHILE TRYING TO FIGURE OUT WHY THE IMAGE DID NOT WORK, THE CATHETER WAS IN THE SAME LOCATION FOR SEVERAL MINUTES WHICH COULD HAVE CONTRIBUTED TO THE VESSEL OCCLUSION WHICH OCCURRED. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED. THREE STENTS WERE IMPLANTED TO ADDRESS THE OCCLUSION AND COMPLETE THE PROCEDURE. THE PATIENT FULLY RECOVERED. HOWEVER, IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE ANTERIOR TIBIAL.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12747804 ↗
• MalfunctionOct 14, 2021Erratic or Intermittent Display; Poor Quality Image

  PATIENT WITH A HISTORY OF CORONARY ARTERY DISEASE AND CORONARY ARTERY BYPASS GRAFT WAS ADMITTED FOR A SCHEDULED HEART CATHETERIZATION. THE IMAGING FROM THE OPTICROSS 6 CORONARY IMAGING CATHETER WAS BLURRY AND DARK, INTERMITTENTLY AND MADE THE PROCEDURE DIFFICULT. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631446 ↗
• DeathJul 14, 2021Entrapment of Device; Failure to Advance; Detachment of Device or Device Component; Entrapment of Device; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CATHETER ROTATION WOULD NOT STOP RESULTING IN THE PATIENT BEING SENT TO THE INTENSIVE CARE UNIT. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. AN OPTICROSS IMAGING CATHETER WAS ADVANCED TO THE CIRCUMFLEX TO EVALUATE THE BLOCKAGE. THE CATHETER TIP THEN BECAME STUCK IN THE BLOCKAGE. THE OPTICROSS WAS ATTEMPTED TO BE WITHDRAWN. FORCE WAS APPLIED TO REMOVE THE CATHETER AND THE DISTAL TIP DETACHED INSIDE THE BLOCKAGE WITHIN THE CIRCUMFLEX. RETRIEVAL ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED TIP. A 1.5MM ROTAPRO BURR CATHETER WAS USED TO ABLATE A PATH TO REACH THE DETACHED TIP. WHILE ATHERECTOMY WAS BEING PERFORMED IN THE ARTERY THE SYSTEM COULD NOT STOP ROTATING. THE POWER WAS TURNED OFF ON THE ROTAPRO CONSOLE. SUBSEQUENTLY, THE PATIENT CODED. THE PATIENT LOST THEIR LEFT ANTERIOR DESCENDING ARTERY AND A PSEUDOANEURYSM FORMED IN THE PROXIMAL AREA OF THE CIRCUMFLEX ARTERY. A LEFT VENTRICULAR ASSIST DEVICE WAS PLACED INSIDE THE PATIENT AND THE LEFT ANTERIOR DESCENDING ARTERY WAS STENTED WITHOUT ISSUE. THE PATIENT STABILIZED AND WAS SENT TO THE INTENSIVE CARE UNIT. IT WAS FURTHER REPORTED THAT THE PATIENT DIED.

  Patient problems: Arrhythmia; Bradycardia; Cardiac Arrest; Chest Pain; Foreign Body In Patient; Low Blood Pressure/ Hypotension; Pseudoaneurysm

  MAUDE report 12169906 ↗
• MalfunctionMar 15, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTANGLEMENT OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL. AN OPTICROSS 6 HD IMAGING CATHETER WAS ADVANCED OVER A LONG NON BOSTON SCIENTIFIC (BSC) WIRE INTO THE MID LAD. A SHORT NON BSC WIRE WAS IN THE SIDE BRANCH DIAGONAL. WHEN THE PHYSICIAN TRIED TO REMOVE THE OPTICROSS CATHETER IT GOT HUNG UP ON THE SIDE BRANCH WIRE AND BOTH THE WIRE AND CATHETER HAD TO BE REMOVED TOGETHER. THE OPTICROSS CATHETER WAS ADVANCED INTO THE LAD OVER THE LONG WIRE ONCE AGAIN AND UPON REMOVAL THE CATHETER GOT STUCK ON THIS WIRE AND BOTH DEVICES HAD TO BE REMOVED TOGETHER. THERE WAS NO HARM TO THE PATIENT BUT DUE TO THE SEVERITY OF THE CALCIFICATION, THE NEXT DAY THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR A ROTAPRO PROCEDURE. THE DEVICE WAS RETURNED WITH A NON- BOSTON SCIENTIFIC WIRE. A VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED A KINK IN THE PROXIMAL SHEATH ASSEMBLY. THERE WAS NO DAMAGE OBSERVED ON THE DISTAL TIP, HOWEVER, THE GUIDEWIRE EXIT PORT ASSEMBLY WAS FOUND DAMAGED(DEFORMED/LIFTED). MICROSCOPIC INSPECTION REVEALED THE GUIDEWIRE EXIT PORT WAS DAMAGED (DEFORMED/LIFTED). THE TEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490399 ↗
• MalfunctionMar 10, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ENTRAPMENT OCCURRED. THE OPTICROSS 6 WAS INTRODUCED FOR VISUALIZATION OF THE TARGET LESION. AFTER IMAGING WAS COMPLETED, THE PHYSICIAN TRIED TO REMOVE THE CATHETER BUT IT SNAGGED THE GUIDEWIRE AND BOTH DEVICES WERE REMOVED TOGETHER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11456963 ↗