Diamondback Coronary DBEC-125 (REF 70058-13)Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 10852528005787), received between Jun 24, 2019 and May 2, 2025 — classified as 11 deaths, 65 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 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 85 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 80% STENOSED, HEAVILY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY (LCX) AND A 90% STENOSED, HEAVILY CALCIFIED DISTAL CIRCUMFLEX ARTERY (CX). TWO LOW SPEED TREATMENTS WERE PERFORMED IN THE LCX AND ONE LOW SPEED TREATMENT WAS PERFORMED IN THE DISTAL CX. THERE WERE NO DEVICE ISSUES OR PATIENT COMPLICATIONS NOTED POST ORBITAL ATHERECTOMY TREATMENT. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 21950171 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - ELEVATED CARDIAC BIOMARKERS WERE OBSERVED DURING POST-PROCEDURE MONITORING FOLLOWING TREATMENT WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE. A TYPE A DISSECTION WAS ALSO NOTED. THE HEALTHCARE PROVIDER DOCUMENTED THAT THE ELEVATION IN BIOMARKER LEVELS AND TYPE A DISSECTION WERE NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, DID NOT LEAD TO A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE EVENT DID NOT RESULT IN ADDITIONAL OR EXTENDED HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED INDICATED THE CLINICAL EVENT COMMITTEE REVIEWED IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction; Vascular Dissection

  MAUDE report 21950143 ↗
• InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ECL-088-045 - FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A TYPE C DISSECTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. ADDITIONAL INFORMATION RECEIVED INDICATED THE CLINICAL EVENT COMMITTEE REVIEWED IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A PERIPROCEDURAL MYOCARDIAL INFARCTION WITH SIDE BRANCH OCCLUSION OBSERVED.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 21950109 ↗
• InjuryMar 21, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS POSITIONED PROXIMAL TO THE 90% STENOSED, HEAVILY CALCIFIED, AND HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH GLIDEASSIST. THERE WAS RESISTANCE AT THE PROXIMAL LAD. DURING THE FIRST TREATMENT ON LOW SPEED, A DRIVESHAFT FRACTURE WAS OBSERVED. A BALLOON CATHETER WAS ADVANCED UNDER THE VIPERWIRE AND THE FRACTURED COMPONENT WAS SUCCESSFULLY REMOVED. NON-ABBOTT DEVICES WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE WITH NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664378 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ECL-152-020 - THE TARGET TREATMENT AREA WAS A 38MM LESION IN 80% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN EIGHT TIMES ON LOW SPEED. ANGIOGRAPHIC IMAGING WAS PERFORMED THAT SHOWED NO PROCEDURAL COMPLICATIONS. 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 19931209 ↗
• InjuryApr 30, 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 IN 3MM, 90% STENOSED, HEAVILY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OAD WAS SPUN FOR 4 TREATMENTS ON LOW SPEED FOR THIRTY SECONDS. ANGIOPLASTY AND A STENT WERE PLACED USING NON-CSI/ABBOTT DEVICES. THE PATIENT HAD ELEVATED TROPONIN THE MORNING POST PROCEDURE. MEDICATIONS OF ASPIRIN, BLOOD THINNER AND BETA BLOCKER WERE ADMINISTERED. THERE WERE NO COMPLAINTS OF CHEST PAIN OR SHORTNESS OF BREATH. THE PATIENT WAS DISCHARGED WITH NO FURTHER COMPLICATIONS. THE CLINICAL EVENT COMMITTEE REVIEW CONCLUDED THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) MAY HAVE CAUSED OR CONTRIBUTED TO THE MYOCARDIAL INFARCTION TYPE 4A IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD).

  Patient problems: Myocardial Infarction

  MAUDE report 19212445 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY WITH A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE DISTAL CIRCUMFLEX ARTERY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18497475 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A TYPE C DISSECTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18495606 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A MYOCARDIAL INFARCTION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Myocardial Infarction

  MAUDE report 18493536 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A TYPE D DISSECTION IN THE MID RIGHT CORONARY ARTERY (RCA). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE CONTRIBUTED.

  Patient problems: Vascular Dissection

  MAUDE report 18493533 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A TYPE C DISSECTION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Vascular Dissection

  MAUDE report 18493531 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND BALLOON ANGIOPLASTY, ANGIOGRAPHIC IMAGING OBSERVED A TYPE C DISSECTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Vascular Dissection

  MAUDE report 18493526 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A TYPE F DISSECTION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18478119 ↗
• InjuryAug 29, 2023Adverse 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 THE DISTAL RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS 3 MM AND 36 MM IN LENGTH, 99% STENOSED AND HEAVILY CALCIFIED. AFTER THREE TREATMENTS A MAJOR DISSECTION WAS OBSERVED. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. NO COMPLICATIONS WERE NOTED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 17644769 ↗
• InjuryFeb 19, 2021Entrapment of Device; Entrapment of Device

  TREATMENT WAS PLANNED FOR A 99.9% STENOSED LESION LOCATED IN THE TORTUOUS MID-RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH BALLOON ANGIOPLASTY AND PLAQUE RUPTURE WAS OBSERVED ON IMAGING. A MICROCATHETER AND BALLOON WERE UNABLE TO PASS THE LESION FOR ADDITIONAL TREATMENT. AS THE VIPERWIRE GUIDE WIRE HAD PASSED THE LESION, DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT. ON THE SECOND TREATMENT PASS TISSUE WRAP OF THE SUBINTIMAL PLANE OCCURRED, AND THE OAD BECAME STUCK IN THE VESSEL. ALL DEVICES WERE REMOVED FROM THE PATIENT, AND A PERFORATION OCCURRED. UNSUCCESSFUL ATTEMPTS WERE MADE TO REWIRE THE LESION FOR 2 HOURS, AND THE PERFORATION WAS LEFT UNTREATED. IT WAS OBSERVED THAT FLOW HAD BEEN RESTORED DISTALLY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE PATIENT WAS STABLE AND DISCHARGED HOME ON (B)(6) 2021 WITH NO ADDITIONAL ANGIOGRAPHY.

  Patient problems: Perforation of Vessels

  MAUDE report 11348085 ↗
• InjuryFeb 16, 2021Material Separation; Material Separation

  FOLLOWING APPROXIMATELY FIVE TREATMENTS ON LOW SPEED IN THE MID RIGHT CORONARY ARTERY (RCA), THE OAD WAS ADVANCED PROXIMAL TO THE NEXT AREA OF INTENDED TREATMENT. BEFORE THE PHYSICIAN COULD PRESS THE ON/OFF BUTTON, THE OAD PITCH CHANGED, AND THE OAD STALLED. THE DISTAL DRIVESHAFT AND CROWN THEN APPEARED TO BE DETACHED FROM THE DEVICE ON IMAGING. THE OAD WAS REMOVED FROM THE PATIENT. THE OAD FRAGMENT WAS SNARED, AND A STENT WAS PLACED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11332190 ↗
• DeathFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING TREATMENT OF A LESION WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE, IMAGING WAS PERFORMED AND SHOWED A SUCCESSFUL RESULT WITH NO VESSEL ISSUE. DURING POST DILATATION WITH NON-COMPLIANT BALLOONS, HIGH PRESSURES WERE USED AND A PERFORATION OCCURRED. BALLOON TAMPONADE WAS PERFORMED TO ADDRESS THE PERFORATION AND IT APPEARED TO BE RESOLVED. DURING BALLOON ANGIOPLASTY IN OTHER AREAS OF THE VESSEL, THE PERFORATION RE-OPENED. STENTS WERE DEPLOYED AND BLOOD THINNERS WERE REVERSED, HOWEVER THIS LED TO CLOTTING IN THE RIGHT CORONARY ARTERY AND BLOOD THINNERS WERE RE-INTRODUCED TO ADDRESS THIS. THE PATIENT LOST PULSE AND A TEMPORARY PACEMAKER WAS INSERTED. THE PATIENT WAS RECOVERED BUT IT WAS REPORTED THAT THE PATIENT LATER EXPIRED.

  Patient problems: Perforation of Vessels

  MAUDE report 11315108 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT TWO LESIONS IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY. THREE TREATMENT PASSES ON LOW SPEED WERE PERFORMED ON EACH LESION, FOLLOWED BY BALLOON ANGIOPLASTY AND STENT PLACEMENT. FOLLOWING FINAL ANGIOGRAPHY, THE POSTERIOR DESCENDING ARTERY WAS NOTED TO HAVE NO DISTAL FLOW. THE VESSEL WAS REWIRED AND BALLOON ANGIOPLASTY WAS PERFORMED TO RESTORE FLOW AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

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

  MAUDE report 11265296 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE TREATMENT PASSES ON LOW SPEED WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) FROM THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TREATMENT TIMES WERE LONG. ANOTHER TREATMENT WAS PERFORMED AT HIGH SPEED IN THE PROXIMAL LAD, AND THE OAD WAS REMOVED. IMAGING WAS PERFORMED, AND SLOW FLOW WAS IDENTIFIED IN THE DISTAL LAD. THE PATIENT COMPLAINED OF CHEST PAIN. NITROGLYCERIN AND ADENOSINE WERE ADMINISTERED; NORMAL FLOW WAS RESTORED, AND THE PATIENT'S CHEST PAIN WAS RESOLVED THEREAFTER. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS STABLE AND WAS SCHEDULED FOR DISCHARGE AS PLANNED.

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

  MAUDE report 11095351 ↗
• InjuryNov 4, 2020Material Separation; Material Separation

  ORBITAL ATHERECTOMY (OA) WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) OF A PATIENT WHO HAD A TEMPORARY PACEMAKER PLACED PRIOR TO THE PROCEDURE. A GUIDE CATHETER WAS INSERTED, AND THE PATIENT'S BLOOD PRESSURE TEMPORARILY DECREASED. THE OAD WAS INSERTED, AND GLIDEASSIST MODE WAS USED TO ADVANCE THE CROWN. THE RCA WAS HIGHLY CALCIFIED AND TORTUOUS. TWO DISTAL-TO-PROXIMAL OA TREATMENTS WERE ADMINISTERED. PRIOR TO THE THIRD TREATMENT PASS, GLIDEASSIST WAS ACTIVATED AGAIN, HOWEVER AN UNEXPECTED AUDIBLE NOISE WAS OBSERVED. ATTEMPTS TO MOVE THE CROWN WERE MADE BY MOVING THE CONTROL KNOB DISTAL AND PROXIMAL AND PULLING ON THE OAD, BUT REMOVAL WAS UNSUCCESSFUL. THE PATIENT'S BLOOD PRESSURE DECREASED AGAIN AND CONTINUED TO FLUCTUATE. A BALLOON PUMP WAS INSERTED TO STABILIZE THE PATIENT'S BLOOD PRESSURE. THE OAD WAS STUCK ON THE WIRE AND BOTH THE OAD AND WIRE WERE REMOVED TOGETHER. THE CROWN AND TIP FRACTURED AND REMAINED IN VIVO. WIRES WERE USED IN AN ATTEMPT TO TRAP THE FRAGMENT, HOWEVER THE FRAGMENT MIGRATED INTO A SMALL BRANCH OF THE POSTEROLATERAL ARTERY. THE PATIENT EXPERIENCED CHEST PAIN AND PRESSURE CHANGES.

  Patient problems: Chest Pain; Foreign Body In Patient; Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 10786573 ↗
• MalfunctionOct 14, 2020Material Separation; Material Separation

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE WAS SELECTED FOR TREATMENT OF LESIONS IN THE MID AND PROXIMAL SEGMENTS OF THE RIGHT CORONARY ARTERY (RCA). THE VESSEL WAS TORTUOUS, AND DIFFICULTY WAS ENCOUNTERED DURING PLACEMENT OF THE GUIDE CATHETER. MULTIPLE GUIDE CATHETERS WERE INSERTED IN AN ATTEMPT TO OBTAIN ADEQUATE SUPPORT. ONCE A GUIDE CATHETER WAS SUCCESSFULLY PLACED, THE VESSEL WAS PRIMARY WIRED WITH A VIPERWIRE GUIDE WIRE. GLIDEASSIST WAS ACTIVATED TO ADVANCE THE CROWN PAST THE TORTUOUS PORTION OF THE PROXIMAL RCA IN ORDER TO TREAT THE DISTAL LESION FIRST. SEVERAL ATHERECTOMY TREATMENTS WERE ADMINISTERED IN THE MID RCA ON LOW SPEED FOR 25 TO 30 SECONDS EACH. THE OAD WAS PULLED BACK IN ORDER TO TREAT THE PROXIMAL LESION. DURING DISTAL TO PROXIMAL TREATMENT, THE GUIDE CATHETER WAS INADVERTENTLY PULLED FARTHER INTO THE VESSEL, AND THE OAD WAS PULLED INTO THE GUIDE CATHETER. THE OAD STALLED. THE DRIVESHAFT HAD ALSO FRACTURED ON THE PROXIMAL SIDE OF THE CROWN. THE GUIDE CATHETER WAS USED TO RETRIEVE THE FRAGMENT, AND EVERYTHING WAS REMOVED FROM THE PATIENT. ANOTHER GUIDE CATHETER WAS PLACED, AND THREE STENTS WERE DEPLOYED. THE PATIENT TOLERATED THE PROCEDURE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10676964 ↗
• InjurySep 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN NSTEMI AND SURGICAL DENIAL, A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE WAS PERFORMED TO TREAT A CALCIFIED CIRCUMFLEX AND A CHRONIC TOTAL OCCLUSION IN THE RIGHT CORONARY ARTERY (RCA). A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED, AND FIVE TREATMENT PASSES WERE PERFORMED ON LOW SPEED; HOWEVER, THE OAD WOULD NOT CROSS THE LESION. DURING TREATMENT, COMPLEX ANATOMY RESULTED IN LACK OF SUPPORT FROM THE FLEX TIP VIPERWIRE GUIDE WIRE. THE OAD DRIVESHAFT AND SALINE SHEATH BECAME PROLAPSED AGAINST THE WALL OF THE LEFT MAIN (LM), AND THE OAD STALLED. THE OAD WAS REMOVED, AND A BALLOON WAS INSERTED; HOWEVER, THE BALLOON WOULD NOT CROSS THE LESION. THE BALLOON WAS INFLATED ONE TIME PROXIMAL TO THE LESION AND WAS REMOVED. A GUIDE CATHETER WAS INSERTED TO PROVIDE SUPPORT, AND THE BALLOON WAS REINSERTED; HOWEVER, IT WOULD AGAIN NOT CROSS THE LESION. A VIPERWIRE GUIDE WIRE ADVANCE WITHOUT FLEX TIP WAS INSERTED FOR ADDED SUPPORT, THE OAD CROSSED THE LESION, AND ADDITIONAL TREATMENT WAS PERFORMED IN THE CIRCUMFLEX ARTERY (CX). ANGIOGRAPHY WAS THEN PERFORMED FOR THE FIRST TIME DURING THE PROCEDURE (DUE TO THE CREATININE LEVELS OF THE PATIENT), AND A PSEUDOANEUR

  Patient problems: Pseudoaneurysm

  MAUDE report 10520790 ↗
• InjurySep 4, 2020Break; Material Separation; Failure to Advance; Device Contamination with Chemical or Other Material

  UNDER LIDOCAINE 1% LOCAL ANESTHESIA A 6 FR INTRODUCER WAS PLACED IN THE RIGHT RADIAL ARTERY USING MODIFIED SELDINGER TECHNIQUE. THE CIRCUMFLEX INTO OM LESION WAS CROSSED USING A 300 CM LENGTH PT MODERATE SUPPORT WIRE. AN ATTEMPT TO ADVANCE A 1.25 OTW BALLOON WAS NOT SUCCESSFUL. A FINE CROSS CATHETER WAS USED TO ADVANCE BEYOND THE BLOCKAGE. THE LONG PT WIRE WAS EXCHANGED TO VIPER WIRE. THE 1.25 TIP ORBITAL ATHERECTOMY DEVICE (CSI) WAS ADVANCED USING THE USUAL TECHNIQUE. LOW SPEED ORBITAL ATHERECTOMY WAS DONE AT THE PROXIMAL LESION, FOLLOWED BY DISTAL OM LESION. THE BURR ADVANCED ANTEGRADE INTO THE LESION. UPON PERFORMING THE CSI FROM THE DISTAL END INTO THE PROXIMAL END OF THE DISTAL LESION USING LOW SPEED RPM, THE DEVICE TIP SEPARATED FROM SHAFT. APPROXIMATELY 3-4 CM OF THE DISTAL DEVICE BROKE OFF. A SECOND WIRE WAS USED TO REWIRE THE LESION. UNDER LIDOCAINE 1% LOCAL ANESTHESIA A 6 FR INTRODUCER WAS PLACED IN THE RIGHT FEMORAL ARTERY USING MODIFIED SELDINGER TECHNIQUE. SEVERAL ATTEMPTS WERE MADE TO PULL BACK THE TIP INTO THE GUIDING CATHETER BUT WERE UNSUCCESSFUL. THIS INCLUDED INFLATING THE BALLOON DISTAL TO THE TIP AND PULLING IT BACK. ALSO INCLUDED USING BALLOON WITH NTG PROXIMA

  Patient problems: Injury; Low Blood Pressure/ Hypotension; Myocardial Infarction; Thrombus

  MAUDE report 10493421 ↗
• DeathAug 28, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. SEVERAL TREATMENTS WERE ADMINISTERED WITHOUT ISSUE. THROUGHOUT THE PROCEDURE THE PATIENT EXPERIENCED NAUSEA AND VOMITING. GLIDEASSIST MODE WAS USED TO SUCCESSFULLY ADVANCE THE OAD TO MID LESION, AND SEVERAL TREATMENT PASSES WERE ADMINISTERED ON LOW SPEED. PER THE PHYSICIAN, IT FELT LIKE THE DEVICE HAD JUMPED, HOWEVER THIS WAS NOT VISIBLY SEEN ON THE ANGIOGRAM. IMAGING WAS PERFORMED, AND NO ISSUES WERE NOTED. ONE MORE TREATMENT PASS WAS PERFORMED, AND THE OAD STALLED. THE PHYSICIAN WAS ADVISED TO STOP TREATMENT AND REMOVE THE DEVICE. IMAGING REVEALED A VESSEL PERFORATION, AND THE PATIENT COMPLAINED OF CHEST PAIN. A BALLOON WAS INSERTED TO TAMPONADE THE VESSEL, AND A RIGHT VENTRICLE INFARCTION OCCURRED AS A RESULT. THE PATIENT WENT INTO PULSELESS ELECTRICAL ARREST AND CODED. ADVANCED LIFE SUPPORT WAS ADMINISTERED FOR 40 (FORTY) MINUTES. A PERICARDIAL TAP WAS PERFORMED, AND A BALLOON PUMP WAS INSERTED. THE PATIENT WAS INTUBATED. WHEN THE PATIENT WAS STABLE, THE PERFORATION WAS RE-ASSESSED AND CONFIRMED TO BE SEALED. THE PATIENT EXPIRED TWO (2) DAYS LATE

  Patient problems: Chest Pain; Death; Perforation of Vessels

  MAUDE report 10464672 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY (LCX). THE VESSEL WAS OCCLUDED WITH GRAFTS, AND THERE WAS NO FLOW INITIALLY THROUGH THE VESSEL. WIRING OF THE VESSEL WAS CHALLENGING AND DONE WITH TWO NON-CSI GUIDE WIRES. A WIRE EXCHANGE WAS PERFORMED, AND THE OAD WAS PLACED AT THE LESION. ON THE FIRST TREATMENT, THE OAD MADE A STALLING NOISE, BUT DID NOT STOP SPINNING. DURING THE SECOND OAD TREATMENT, THE PATIENT PRESENTED WITH CHEST PAIN. IMAGING REVEALED THAT FLOW HAD NOT IMPROVED. THE OAD WAS REMOVED, AND IMAGING THEN SHOWED A PERFORATION IN THE PROXIMAL LCX. BALLOON ANGIOPLASTY AND STENTING WAS PERFORMED. IN THE OPINION OF THE PHYSICIAN, THE INITIAL NON-CSI GUIDE WIRES CREATED OR LIFTED A DISSECTION FLAP, AND THE OAD EXACERBATED THE DISSECTION INTO A PERFORATION. FOLLOWING THE PROCEDURE, THE PATIENT WAS STABLE AND THE VESSEL EXHIBITED ADEQUATE FLOW.

  Patient problems: Chest Pain; Perforation of Vessels

  MAUDE report 10455424 ↗