Diamondback Coronary DBEC-125 (REF 7-10060-09)Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 10850026568087), received between Aug 3, 2021 and Jul 2, 2025 — classified as 30 deaths, 117 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (36 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 162 reports, in the reporter's own words as published by the FDA.

• DeathJul 2, 2025Unintended System Motion; Failure to Advance; Unintended System Motion; Failure to Advance

  IT WAS REPORTED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF HEAVILY CALCIFIED, HEAVILY TORTUOUS, 98-99% STENOSED LESION IN PROXIMAL TO MID RIGHT CORONARY ARTERY (RCA). PRIMARY WIRING WITH THE VIPERWIRE WAS ATTEMPTED BUT IT COULD NOT GET THROUGH. THE VIPERWIRE WAS EXCHANGED FOR A FEW DIFFERENT UNSPECIFIED WIRES AND FINALLY CROSSED WITH A NON-ABBOTT GUIDE WIRE. THE OAD WAS THEN ADVANCED BUT COULD NOT CROSS THE LESION IN THE RCA DURING SEVERAL ATTEMPTS DUE TO PATIENT ANATOMY. THE WIRE WAS STARTING TO COME BACK WHILE TRYING TO ADVANCE THE CROWN. OAD SPINNING WAS STOPPED AND THE TIP BUSHING WAS ATTEMPTED TO BE ADVANCED FURTHER INTO THE LESION WITH THE OAD OFF TO ADD SUPPORT TO ADVANCING THE VIPERWIRE FURTHER INTO THE RCA BUT THE WIRE COULD NOT BE ADVANCED DUE TO LACK OF GUIDE SUPPORT. AROUND THIS TIME, IT WAS REALIZED THE TIP BUSHING OF THE OAD APPEARED TO BE OUTSIDE THE VESSEL WALL. ANGIOGRAPHIC IMAGE SHOWED A LARGE VESSEL PERFORATION THAT WAS BLEEDING INTO THE PERICARDIUM. THE OAD WAS THEN REMOVED, AND ALL WIRE POSITIONS WERE LOST DURING OAD REMOVAL. THE PHYSICIAN WAS ABLE TO WIRE

  Patient problems: Ischemia; Perforation of Vessels

  MAUDE report 22386444 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A DISTAL RIGHT CORONARY ARTERY. THE SITE DID NOT REPORT ANY ADVERSE EVENTS. FOLLOWING REVIEW OF PROCEDURAL FILMS, THE CLINICAL EVENTS COMMITTEE OBSERVED A MYOCARDIAL INFARCTION. THE CEC CONCLUDED THAT ORBITAL ATHERECTOMY WAS POSSIBLY RELATED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 21893910 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY, A DISSECTION WAS NOTED PROXIMAL TO THE STENT EXTENDING INTO THE OSTIUM ACROSS THE AORTA. STENT PLACEMENT AND BALLOON ANGIOPLASTY WERE PERFORMED. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION RECEIVED FOLLOWING REVIEW FROM CLINICAL EVENTS COMMITTEE CONCLUDED THAT A MYOCARDIAL INFRACTION OCCURRED DURING THE PROCEDURE AND ORBITAL ATHERECTOMY WAS POSSIBLY RELATED.

  Patient problems: Myocardial Infarction; Vascular Dissection

  MAUDE report 21893830 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING THE PROCEDURE, THE CLINICAL EVENTS COMMITTEE OBSERVED A MYOCARDIAL INFARCTION AND CONCLUDED THAT ATHERECTOMY MAY HAVE CONTRIBUTED. THE SITE DID NOT REPORT ANY PATIENT ADVERSE EFFECTS DURING THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 21893127 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 80% STENOSED, SEVERELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA) AND A 71% STENOSED, SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THREE LOW SPEED TREATMENTS WERE PERFORMED ON THE MID LAD. FOUR LOW SPEED TREATMENTS WERE PERFORMED AND ONE HIGH SPEED TREATMENT WAS PERFORMED ON THE MID RCA. THERE WERE NO DEVICE DEFICIENCIES NOTED DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS RELATED TO ORBITAL ATHERECTOMY NOTED DURING THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION, AS SIDE BRANCH OCCLUSION WAS OBSERVED.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 21891355 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE CORONARY WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF HEAVILY CALCIFIED, NON-TORTUOUS, 98% STENOSED LESION IN OBTUSE MARGINAL ARTERY (OM) THROUGH FEMORAL ARTERY ACCESS. ACCESS WAS GAINED USING NON-ABBOTT GUIDE WIRE. AN UNSPECIFIED MICROCATHETER WAS PLACED ON TOP OF IT AND THE NON-ABBOTT GUIDE WIRE WAS EXCHANGED WITH THE VIPERWIRE. THE OAD WAS CONFIRMED TO BE WORKING EX VIVO. THE OAD WAS ADVANCED AND ANTEGRADE LOW-SPEED TREATMENT WAS PERFORMED. A PITCH CHANGE TO LOW-PITCH SOUND WAS HEARD INSTEAD OF THE NORMAL HIGH PITCH TRANSITION BUT THE PHYSICIAN THOUGHT THIS WAS NORMAL AND CONTINUED TREATMENT. THE OAD WAS STOPPED FOR TWENTY-FIVE-SECOND REST. A RETROGRADE TREATMENT ON LOW SPEED FORWARD FOLLOWED. THE OAD WAS RESTED FOR TWENTY-FIVE-SECONDS. A THIRD LOW-SPEED TREATMENT WAS PERFORMED FORWARD. ANGIOGRAPHIC IMAGES SHOWED PERFORATION IN OM. ECHOCARDIOGRAM WAS PERFORMED DUE TO CONCERN FOR TAMPONADE. NO PLEURAL EFFUSION WAS FOUND. THE OAD WAS REMOVED. TO RESOLVE THE PERFORATION, A 2.0 X 12 NON-ABBOTT BALLOON WAS ADVANCED OVER THE VIPERWIRE BUT IT WAS OBSERVED THE VIPERWIRE WAS NOT TRACKING IN THE RIGHT

  Patient problems: Angina; Perforation of Vessels

  MAUDE report 21733796 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF MEDIUM-TO-HEAVILY CALCIFIED, 85% STENOSED, 3.0MM-DIAMETER LESION IN CIRCUMFLEX ARTERY (CFX) VIA FEMORAL ACCESS. THE OAD WAS ADVANCED TO THE LESION WITHOUT ANY ISSUES. THREE LOW-SPEED TREATMENTS FOR 25 SECONDS OR LESS EACH WERE PERFORMED. A TEST OF CONTRAST WAS TAKEN, AND NO ISSUES WERE FOUND. AFTER THE THIRD RUN, THE OAD WAS REMOVED. IMAGE WAS TAKEN WHICH SHOWED A SMALL PERFORATION. AN ABBOTT TELEPORT MICROCATHETER WAS QUICKLY LOADED OVER THE VIPERWIRE GUIDE WIRE. THE VIPERWIRE WAS EXCHANGED WITH NON-CSI/NON-ABBOTT GUIDE WIRE FOR MORE SUPPORT AND USED TO DEPLOY A 3.0MM ABBOTT TREK BALLOON. THE TELEPORT WAS REMOVED. THE 3.0MM ABBOTT TREK BALLOON WAS USED TO TAMPONADE THE PERFORATION. A 35 X 20 NON-ABBOTT STENT PLACEMENT WAS ALSO PERFORMED TO RESOLVE THE PERFORATION. POST DILATION WITH 3.25 X 8MM ABBOTT NC TREK NEO CORONARY DILATATION CATHETER FOLLOWED. AN ECHOCARDIOGRAM WAS TAKEN TO ENSURE THERE WAS NO SIGNIFICANT BLEEDING AROUND THE HEART. ABBOTT PERCLOSE PROGLIDE SUTURE-MEDIATED CLOSURE SYSTEM WAS USED TO CLOSE THE ACCESS SITE. IN THE OPINION OF THE PHYSICIAN, THERE MUST HAVE BEEN A SHORT KINK IN

  Patient problems: Perforation of Vessels

  MAUDE report 20525791 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF 80% STENOSED, SEVERELY CALCIFIED, 3MM-DIAMETER LESION IN PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY VIA RIGHT FEMORAL APPROACH. FOUR LOW-SPEED TREATMENTS WERE PERFORMED AT THE TARGET LESION. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19986384 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF AN 80% STENOSED, SEVERELY CALCIFIED LESION IN MID RIGHT CORONARY ARTERY (RCA) VIA RIGHT FEMORAL ON (B)(6) 2022. SIX LOW-SPEED TREATMENTS WERE PERFORMED. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. DURING A FOLLOW-UP VISIT IN CLINIC ON (B)(6) 2023, THE PATIENT WAS ADMITTED FOR RECURRENT CHEST DISCOMFORT AND ELEVATED TROPONINS CONSISTENT WITH TYPE ONE NON-Q-WAVE NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WITH ACUTE MYOCARDIAL ISCHEMIA. THE MID RCA LESION WAS FOUND TO BE 90% STENOSED WITH IN-STENT RESTENOSIS (ISR). BALLOON ANGIOPLASTY AND TWO STENT PLACEMENTS WERE PERFORMED TO RESOLVE THE NSTEMI. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY WITHOUT FURTHER COMPLICATIONS AND MEDICAL INTERVENTION. IN THE OPINION OF THE PHYSICIAN, THE CSI DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE MYOCARDIAL INFARCTION AND ISR - NSTEMI WAS SECONDARY TO ISR. ON 15JULY2024, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL EVENT COMMITTEE (CEC). THE CEC REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED T

  Patient problems: Angina; Cardiac Enzyme Elevation; Ischemia; Myocardial Infarction; Restenosis

  MAUDE report 19963588 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TARGET TREATMENT AREA WAS A 4MM, 75% STENOSED, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN FOR A TOTAL OF 11 TIMES FOR TREATMENT, 8 TIMES ON LOW SPEED AND 3 TIMES OH HIGH SPEED. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19762114 ↗
• InjuryJul 10, 2024Activation Failure; Activation Failure

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WOULD NOT POWER ON DURING THE PROCEDURE. THIS RESULTED IN A CLINICALLY SIGNIFICANT DELAY TO THE PATIENT. THE PATIENT EXPERIENCED AMINOPHYLLINE TOXICITY DUE TO THE PROLONGED CASE. A NEW OAD WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19714533 ↗
• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN A 95% STENOSED, CALCIFIED AND TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A DIAGONAL BRANCH BEND. FOLLOWING AN UNSUCCESSFUL ATTEMPT TO ADVANCE A SAPPHIRE BALLOON, THE OAD WAS ADVANCED. THE OAD WAS SPUN FOR TWO TREATMENTS ON LOW SPEED. A PERFORATION WAS OBSERVED IN THE BEND OF THE LAD. THE PATIENT BEGAN EXPERIENCING CHEST PAIN, LOW BLOOD PRESSURE AND LOSS OF THE DIAGONAL BRANCH. SEVERAL STENTS, FOLLOWED BY TWO COVERED STENTS PLACED DISTAL AND PROXIMAL WAS PERFORMED TO TREAT THE PERFORATION. ECHO SHOWED A SMALL AMOUNT OF FLUID IN THE PERICARDIUM, BUT NO ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED (PCI). THE PATIENT WAS STABLE. THE PHYSICIAN'S OPINION WAS THE OAD CAUSED THE PERFORATION, BUT THE PATIENT'S ANATOMY MAY HAVE CONTRIBUTED.

  Patient problems: Chest Pain; Low Blood Pressure/ Hypotension; Perforation of Vessels; Pericardial Effusion; Reduced Blood Flow

  MAUDE report 19340655 ↗
• DeathMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT 95% STENOSED, HEAVILY CALCIFIED, 3.5MM PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THREE LOW-SPEED TREATMENTS WERE PERFORMED WITH INJECTIONS IN BETWEEN EACH TREATMENT. AFTER SUCCESSFUL TREATMENT, THE OAD WAS REMOVED, HOWEVER, THE VIPERWIRE ADVANCE GUIDE WIRE WAS PULLED DURING THE REMOVAL OF THE OAD AND THE WIRE POSITION WAS LOST. THE OAD AND VIPERWIRE WERE REMOVED TOGETHER. THE VESSEL WAS RE-WIRED WITH A NON-CSI GUIDE WIRE. A PERFORATION WAS OBSERVED ON FLUOROSCOPY. MULTIPLE BALLOONS AND STENTS WERE USED IN AN ATTEMPT TO TREAT THE PERFORATION. THE PATIENT'S ACTIVATED CLOTTING TIME WAS OVER 600 SECONDS. PERICARDIOCENTESIS WAS PERFORMED AND AN ECHOCARDIOGRAM WAS USED. HEMATOMA DEVELOPED. THE PATIENT CODED AND EXPIRED.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 19330800 ↗
• InjuryMay 3, 2024Entrapment of Device; Entrapment of Device

  THE TREATMENT WAS PERFORMED ON TWO SERIAL LESIONS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. BOTH LESIONS WERE 99% STENOSED AND SEVERELY CALCIFIED WITH VESSEL SIZE OF 3 MM. DURING PROXIMAL TREATMENT OF THE SECOND LESION WHICH WAS DISTAL TO THE FIRST LESION IN A TORTUOUS LOCATION, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) STALLED DUE TO HEAVY AND SEVERE CALCIFICATION OF THE DISTAL LESION WITH SOME TORTUOSITY AND THE CROWN WAS STUCK IN THE SEVERELY CALCIFIED LESION. GLIDE ASSIST WAS TURNED ON IN AN ATTEMPT TO MOVE THE CROWN OUT OF THE LESION. WHEN LOW SPEED WAS TURNED ON, THE CROWN COULD NOT MOVE WITH ADVANCEMENT OF THE CROWN ADVANCER KNOB. A SECOND NON-CSI/NON-ABBOTT GUIDEWIRE WAS USED TO ADVANCE PAST THE CROWN TO DILATE WITH A SMALL RX SEMI-COMPLIANT BALLOON WHICH WAS UNSUCCESSFUL. THE SALINE SHEATH AND DRIVESHAFT WERE CUT FROM THE OAD IN AN ATTEMPT TO USE AS A MICROCATHETER OVER THE DRIVESHAFT AND CROWN. THE SHEATH WAS UNABLE TO ADVANCE ON THE DRIVESHAFT. SECOND RIGHT FEMORAL ACCESS WAS OBTAINED TO USE A "PING PONG" METHOD BY DISENGAGING THE RADIAL GUIDE CATHETER FROM THE LEFT MAIN ARTERY AND PLANT IT IN THE AORTA AND PLACE A FEMORAL GUIDE CATHETER IN TH

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19240131 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A HIGH-RISK TREATMENT OF A 99% STENOSED, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD), A 6F EXTRA BACK UP (EBU) GUIDE CATHETER WAS ADVANCED, FOLLOWED BY THE VIPERWIRE ADVANCE GUIDE WIRE AND DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). THE OAD WAS SPUN FOR FIVE TREATMENTS ON LOW SPEED. THE PATIENT THEN DEVELOPED HEMODYNAMIC INSTABILITY. THE OAD WAS REMOVED, BUT IMAGING COULD NOT BE TAKEN AS ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) STEPS WERE PRIORITY. CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED SEVERAL TIMES, IMPELLA AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WERE PLACED. THE PATIENT'S BLOOD FLOW AND PULSE RESTORED. THE PHYSICIAN'S OPINION, PATIENT'S ANATOMY ATTRIBUTED TO THE HEMODYNAMIC INSTABILITY.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 19212005 ↗
• InjuryApr 17, 2024Material Separation; Material Separation

  DURING CORONARY PROCEDURE TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) VESSEL, FOUR TREATMENTS ON LOW SPEED AND FOUR TREATMENTS ON HIGH SPEED WERE PERFORMED IN THE LEFT CIRCUMFLEX VESSEL USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). FOLLOWING THE LAST TREATMENT, THE DRIVESHAFT WAS OBSERVED TO BE FRACTURED DISTAL TO THE CROWN. THE FRACTURED FRAGMENT WAS SUCCESSFULLY RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED BY INTRAVASCULAR LITHOTRIPSY (IVL) AND STENTING. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND IS NOW DISCHARGED AND IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19128594 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 2.5MM, 90% STENOSED, HEAVILY CALCIFIED WITH MILD TORTUOSITY LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OAD WAS SPUN FOR ONE TREATMENT ON LOW SPEED AND A PERFORATION WAS OBSERVED IN THE MID LAD. THE PATIENT DECLINED, CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED FOR TWENTY TO THIRTY MINUTES WHILE SIMULTANEOUSLY PERFORMING PERICARDIOCENTESIS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ONE LITER OF BLOOD WAS DRAINED FROM THE HEART. THREE NON-CSI/ABBOTT BALLOONS AND THREE NON-CSI/ABBOTT STENTS WERE USED AND PLACED TO SUCCESSFULLY TREAT THE PERFORATION. FLOW WAS RESTORED AND THE PATIENT WAS STABLE AND PLACED ON A VENTILATOR AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE FOLLOWING DAY THE PATIENT'S DEPENDANCE ON THE VENTILATOR WAS REDUCED. IT WAS THE PHYSICIAN'S OPINION THE OAD CAUSED THE PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 19095968 ↗
• InjuryApr 1, 2024Material Separation; Material Separation

  DURING TREATMENT WITH THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) ON A CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA), THE CROWN FRACTURED FROM THE NOSE CONE. THE FRACTURE OCCURRED AFTER THE FIFTH LOW SPEED TREATMENT WAS PERFORMED. A PARALLEL WIRE WAS USED TO RETRIEVE THE OAD AND VIPERWIRE ADVANCE GUIDE WIRE. NO COMPONENTS REMAINED IN THE PATIENT. A HIGH-PRESSURE BALLOON AND INTRAVASCULAR LITHOTRIPSY (IVL) WERE PERFORMED, FOLLOWED BY A STENT PLACEMENT TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY AND IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 19014206 ↗
• MalfunctionMar 27, 2024Off-Label Use; Off-Label Use

  THE TARGET TREATMENT AREA WAS A 90% STENOSED, HEAVILY CALCIFIED, LEFT ANTERIOR DESCENDING ARTERY (LAD). A PREVIOUSLY PLACED STENT WAS NOTED IN THE LEFT MAIN THAT HAD IN STENT RESTENOSIS (ISR) WITH CALCIUM OUTLINES UNDER ANGIOGRAPHY. A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED OFF LABEL TO SPIN WITHIN THE PREVIOUSLY PLACED STENT. THE OAD WAS SPUN ON LOW SPEED FOR 4 TO 5 TREATMENTS. THE OAD WAS REMOVED, AND NO DAMAGE WAS OBSERVED TO THE OAD OR VIPERWIRE ADVANCE GUIDE WIRE. AN XIENCE SKYPOINT STENT WAS THEN PLACED IN THE LEFT MAIN AND PROXIMAL (LAD) AND ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985809 ↗
• InjuryMar 26, 2024Material Separation; Material Separation

  THE INTENDED PROCEDURE WAS LEFT HEART CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION ON A PATIENT. THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN THE RIGHT CORONARY ARTERY AND CIRCUMFLEX ARTERY. UPON REMOVAL OF OAD, IT WAS OBSERVED THAT THE TIP OF THE OAD PROXIMAL TO BURR WAS BROKEN OFF. THE FRAGMENT WAS RETRIEVED ON THE GUIDE WIRE. BREAKAGE WAS NOTED AFTER ATHERECTOMY WAS COMPLETE AND AFTER VESSEL PREPARATION WAS FINISHED. MEDWATCH REPORT NUMBER: (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 18978009 ↗
• MalfunctionMar 8, 2024Material Separation; Material Separation

  DURING TREATMENT OF A MODERATELY TORTUOUS, HEAVILY CALCIFIED 80% STENOSED LESION ABOUT 4MM IN DIAMETER IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN FIVE TIMES ON LOW SPEED WITH NO ISSUES. UPON REMOVAL OF OAD, IT WAS OBSERVED THAT THE DRIVESHAFT OR TIP OF THE OAD HAD DETACHED, BUT REMAINED ON THE VIPERWIRE ADVANCE GUIDEWIRE AND WAS REMOVED WITH THE VIPER WIRE. THE DETACHED PART WAS COMPLETELY REMOVED FROM THE BODY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866391 ↗
• MalfunctionFeb 27, 2024

  WHILE REMOVING CSI ATHERECTOMY DEVICE, PROCEDURALIST NOTICED THAT TIP OF EQUIPMENT PROXIMAL TO BURR WAS BROKEN OFF. WAS RETRIEVED ON WIRE PER PROCEDURAL OPERATOR. DEVICE HAD BEEN USED IN RCA (RIGHT CORONARY ARTERY) AND CIRCUMFLEX AR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788199 ↗
• DeathFeb 21, 2024Unintended System Motion; Adverse Event Without Identified Device or Use Problem; Unintended System Motion; Adverse Event Without Identified Device or Use Problem

  FOLLOWING TREATMENT AND BALLOON RUPTURE OF THE SHOCKWAVE DEVICE, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED AND USED FOR TREATMENT. THE PATIENT EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chest Pain; Device Embedded In Tissue or Plaque; Insufficient Information; Vascular Dissection

  MAUDE report 18746819 ↗
• DeathFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A HIGHLY CALCIFIED, 99% STENOSED, 3.5MM LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) VIA RETROGRADE FEMORAL ACCESS. THE PROXIMAL LESION WAS TREATED WITH THREE LOW SPEED TREATMENTS. GLIDEASSIST WAS USED TO ADVANCE THE CROWN TO THE MID RCA PRIOR TO ENGAGING AND TREATING THE MID RCA LESION. TWO OAD LOW-SPEED TREATMENTS WERE PERFORMED. CINE CARDIAC IMAGING DID NOT SHOW EXTRAVASATION. AFTER THE THIRD LOW-SPEED TREATMENT, THE PATIENT FELT CHEST DISCOMFORT. AN ANGIOGRAM REVEALED A LARGE EXTRAVASATION TO PERICARDIUM. SEVERAL SIZES OF BALLOONS WERE USED IN AN ATTEMPT TO PREVENT THE CARDIAC TAMPONADE. INTERVENTIONS TO RESOLVE THE ADVERSE EVENT WERE UNSUCCESSFUL, AND THE PATIENT EXPIRED.

  Patient problems: Chest Pain; Perforation of Vessels

  MAUDE report 18685081 ↗
• InjuryJan 31, 2024Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  FOLLOWING A DIFFICULT WIRE EXCHANGE FOR THE VIPERWIRE ADVANCE GUIDE WIRE, THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN A 3.5MM, 95% STENOSED AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). DIFFICULTY WAS EXPERIENCED WHEN ADVANCING THE OAD AND THE OAD COULD NOT CROSS THE LONG DIFFUSED, HEAVILY CALCIFIED LESION. 15 SPIN ATTEMPTS AT 30 SECONDS WERE MADE TO CROSS THE LESION BUT WERE UNSUCCESSFUL. THE OAD WAS REMOVED AND THE DIAMOND COATING ON THE OAD CROWN APPEARED TO HAD BEEN COMPLETELY WORN OFF. A NEW OAD WAS NOT AVAILABLE ONSITE, CAUSING THE PROCEDURE TO BE ABORTED. THE PATIENT WAS SENT TO ICU AND GIVEN THE OPTION TO TRY ROTATIONAL ATHERECTOMY OR BYPASS. DURING DEVICE ANALYSIS, IT WAS IDENTIFIED THE OAD CROWN WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614525 ↗