Diamondback Coronary DBEC-125 (REF 7-10098-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10850026568698), received between Mar 11, 2024 and Sep 21, 2026 — classified as 18 deaths, 30 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (9 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 60 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Entrapment of Device

  It was reported a Diamondback 360 Coronary Orbital Atherectomy System (OAS) was stuck in a heavily calcified, heavily tortuous right coronary artery (RCA). This resulted in a small perforation. The vessel was attempted to be wired for a balloon to be inserted in an attempt to free the device, however, this was aborted and the OAD was able to be removed from the patient without intervention. The perforation was treated with balloon tamponade with two long inflations.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 50838133 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Perforation of Vessels

  MAUDE report 50573555 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the procedure was to treat a de novo, heavily calcified, moderately tortuous left anterior descending (LAD) artery lesion with 98% stenosis. The vessel was ballooned and a 1.25mm Diamondback coronary orbital atherectomy device was used. Both a 3x28 mm Xience Skypoint drug-eluting stent (DES) and a 3.25x18 mm Xience Skypoint DES were implanted without issue. A non-Abbott guide wire caused the LAD to dissect and shut down flow distal to the stent edge. The circumflex (CX) artery also shut down. Angios performed before and after the procedure confirmed the circumflex was no longer open and likely clotted with persistent no flow. It was noted that the non-Abbott wire had lost position. When the wire lost position, the physician was able to get the guide back in left main artery and took a picture that confirmed dissection. The dissection was distal to the stent and spiraled down the LAD. Dissection and shut down of CX were not treated. The physician attempted to use a balloon pump and performed chest compressions shocking the patient. The patient later died due to dissection. The physician was not sure about what caused the CX to shut down but believed the non-Abbo

  Patient problems: Obstruction/Occlusion

  MAUDE report 50409067 ↗
• InjuryAug 3, 2026Entrapment of Device

  It was reported that a Diamondback 360 Coronary Orbital Atherectomy Device (OAD) was used to treat the left main and circumflex arteries. Upon removal, the crown became stuck in the vessel. A secondary wire and balloon were used to free the crown from the vessel. There was no clinically significant delay to the procedure and no patient adverse effects. There is no additional information.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 50122270 ↗
• MalfunctionJul 31, 2026Fluid/Blood Leak; Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50101639 ↗
• MalfunctionJul 1, 2026Material Separation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN ATTEMPTED TO USE A 1.5 ROTATIONAL ATHERECTOMY DEVICE BUT IT STALLED AND GOT STUCK IMMEDIATELY. A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS THEN INSERTED AND 4 PROXIMAL-TO-DISTAL TREATMENTS WERE PERFORMED ON LOW SPEED. WHILE REMOVING THE OAD FROM THE BODY, IT WAS NOTICED THAT THE DRIVESHAFT WAS FRACTURED AT THE CROWN. THE OAD AND THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WERE REMOVED AS A SYSTEM. THE VESSEL WAS REWIRED AND A 3.0 NON-ABBOTT BALLOON WAS USED TO FULLY TREAT THE CALCIUM FOLLOWED BY BALLOONING AND STENT PLACEMENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN BELIEVED THE FRACTURE OCCURRED DUE TO THE ANGULATION AND SEVERITY OF CALCIFICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681392 ↗
• DeathJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 90% STENOSED HEAVILY CALCIFIED MID PROXIMAL CIRCUMFLEX ARTERY WITH MILD TORTUOSITY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). PERFORATION OCCURRED IN THE LEFT MAIN (LM) TO OSTIAL CIRCUMFLEX DURING ATHERECTOMY. THE PATIENT EXPERIENCED CARDIAC ARREST AND EXPIRED. IT WAS NOTED THAT THE PHYSICIAN USED CORRECT PROCEDURE TECHNIQUE AND THERE WAS NO ALLEGED MALFUNCTION OF THE DEVICE.

  Patient problems: Cardiac Arrest; Perforation of Vessels; Vascular Dissection

  MAUDE report 25616643 ↗
• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ATHERECTOMY WAS PERFORMED TO TREAT 80% STENOSED MODERATELY CALCIFIED, MILDLY TORTUOUS MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER MULTIPLE GUIDE SELECTIONS WERE MADE, A NON- ABBOTT WIRE WAS ADVANCED PAST THE LESION. A MICROCATHETER WAS ADVANCED OVER THE GUIDEWIRE AND EXCHANGED FOR THE VIPERWIRE CORONARY FLEX TIP GUIDEWIRE. THE MICROCATHETER WAS REMOVED AND A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED OVER THE VIPERWIRE CORONARY GUIDEWIRE. SEVEN TREATMENTS VARYING BETWEEN 30 AND 32 SECONDS WERE PERFORMED AT LOW SPEED. PATIENT TOLERATED WELL AND THE LESION WAS TREATED. THE PATIENT¿S PRESSURE BEGAN TO DROP AND A QUICK ANGIOGRAM WAS PERFORMED DISCOVERING A PERFORATION OF THE MID LAD. ALL ATHERECTOMY EQUIPMENT WAS REMOVED FROM THE PATIENT AND LIFE SAVING MEASURES WERE STARTED. AFTER CONSULTING WITH OTHER INTERVENTIONAL CARDIOLOGIST AND AS IT WAS UNABLE TO GET A BALLOON OR A COVERED STENT DOWN THE VESSEL, THE PATIENT WAS TRANSFERRED TO OPEN HEART SURGERY THAT WAS SUCCESSFUL. IN THE OPINION OF THE PHYSICIAN, THE OAD CAUSED PATIENT'S HYPOTENSION AND PERFORATION. THE PATIENT'S BASE HEART RATE WAS IN 70S. THE PERFORATION CAUSED BY THE OAD

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 25487925 ↗
• DeathApr 24, 2026Difficult to Remove; Material Separation; Unexpected Shutdown

  It was reported a Diamondback 360 Coronary Orbital Atherectomy Device (OAD) was being used to treat a heavily calcified, heavily tortuous, 99% stenosed distal left main (LM)/ostial left circumflex (CX). The patient was given heparin prior to orbital atherectomy, and an Impella CP was placed in the patient's right femoral artery. A single access 7Fr sheath and guide system was utilized. A non-Abbott interventional wire, along with a non-Abbott microcatheter, were used to get across the lesion initially. The ViperWire Guide Wire was able to be exchanged in. There were no apparent issues during preparation of the OAD. The OAD was successfully loaded onto the ViperWire, and advanced just proximal to the lesion. A low-speed treatment was performed for five seconds, as the guide catheter was pushing out and there was difficulty remaining engaged. It was determined at this time that the physician was to use GlideAssist mode to get closer to the lesion and help seat the guide catheter better. GlideAsisst mode was used to get the OAD next to the lesion better. During this time, the brake lever was not engaged, as they were moving the entire OAD at the time. The brake lever was locked prior

  Patient problems: Cardiac Arrest; Foreign Body In Patient; Perforation of Vessels; Vascular Dissection

  MAUDE report 24984289 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI), RADIAL ACCESS WAS USED AS BOTH LEG ARTERIES WERE TOO COMPLICATED TO PERFORM THE PROCEDURE. A WORKHORSE WIRE WAS ADVANCED ACROSS THE LESION IN THE RIGHT CORONARY ARTERY (RCA) WITHOUT COMPLICATION, THEN A TURNPIKE WAS USED TO EXCHANGE FOR THE VIPERWIRE FLEX TIP CORONARY GUIDEWIRE. AFTER SUCCESSFULLY GETTING THE VIPERWIRE IN THE VESSEL AND ACROSS THE LESION, A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SET UP. AFTER SEVEN TREATMENTS ON LOW SPEED, THE OAD WAS REMOVED AND A SEMI-COMPLIANT BALLOON WAS ADVANCED TO TREAT THE LESION. AFTER GOING UP ON THE BALLOON, A CINE WAS PERFORMED AND PERFORATION WAS OBSERVED IN THE PROXIMAL SEGMENT OF THE RCA. THREE COVERED STENTS AND ONE NON-COVERED STENT WERE USED ALONG WITH A SERIES OF BALLOONS SUCCESSFULLY. THE PATIENT WAS STABLE. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FURTHER MEDICAL TREATMENT. IN THE OPINION OF THE PHYSICIAN, THE OAD CAUSED PERFORATION.

  Patient problems: Perforation of Vessels

  MAUDE report 24915407 ↗
• DeathMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT HEAVILY CALCIFIED, NON-TORTUOUS, 85% STENOSED PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH DIAMONDBACK 360 PRECISION ORBITAL ATHERECTOMY DEVICE (OAD). THE LESION WAS PRIMARY WIRED WITH VIPERWIRE ADVANCE CORONARY GUIDE WIRE (FLOPPY) THROUGH RIGHT FEMORAL ARTERY ACCESS. FROM ANGIOGRAM IT APPEARED THE VIPERWIRE WAS IN TRUE LUMEN, SITTING IN MID TO DISTAL RCA, STRAIGHT AND NOT IN A BRANCH. NO VESSEL PREPARATION WAS PERFORMED. SEVERAL LOW-SPEED OAD TREATMENTS WERE PERFORMED FOLLOWED BY 2 HIGH-SPEED TREATMENTS. AFTER OAD REMOVAL, ANGIOGRAPHIC IMAGES SHOWED NO REFLOW IN THE TREATED RCA. THE PATIENT BECAME APNEIC (SHORT OF BREATH) AND BLOOD PRESSURE DROPPED TO LOW (HYPOTENSION). CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY MEDICATIONS WERE ADMINISTERED INCLUDING ATROPINE BUT PATIENT DID NOT RESPOND. ECHO CARDIOGRAM WAS TAKEN BUT NO PERFORATION WAS OBSERVED. THE PATIENT EXPIRED AFTER 45 MINUTES OF UNSUCCESSFUL RESUSCITATION EFFORTS. THE PHYSICIAN THINKS THE PATIENT¿S DISEASE CONTRIBUTED TO THE EVENT AND THERE WAS SOMETHING ELSE GOING ON WITH PATIENT¿S STABILITY AND SICKNESS MAKING HER UNABLE TO TOLERATE THE TREATMENT. IN THE OPINION OF THE P

  Patient problems: Cardiac Arrest; Dyspnea; Embolism/Embolus; Low Blood Pressure/ Hypotension

  MAUDE report 24729264 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 95% STENOSED SEVERELY CALCIFIED TIGHT MID RIGHT CORONARY ARTERY LESIONS WITH MILD TORTUOSITY, A NON-ABBOTT 6F GUIDE WAS USED TO PRIMARILY WIRE THE VESSEL WITH VIPERWIRE ADVANCE CORONARY GUIDEWIRE. THE VESSEL WAS 2.75-3.0MM IN DIAMETER AND 50 MM IN LENGTH. THE VESSEL WAS PREPPED AND A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED JUST PROXIMAL TO THE LESION. WITHIN THE SPECIFIC AREA/LESION THAT WAS BEING TREATED, THERE WERE TWO TIGHTER SPOTS. TWO TREATMENTS WERE PERFORMED WITHOUT ANY JUMP FOR APPROXIMATELY 27 SECONDS ALL THE WAY TO THE END OF THE PLANNED TREATMENT AREA. THE TREATMENT WAS PAUSED 1:1 AND THEN TREATMENT WAS PERFORMED FOR APPROXIMATELY 27 SECONDS. THE TREATMENT WAS RESTED 1:1 AND REPEATED THRICE. THERE WERE PUFFS TAKEN BETWEEN RUNS TO MAKE SURE VESSEL REMAINED OPEN AND THERE WERE NO ISSUES. OCCASIONAL PUFFS OF CONTRAST TAKEN BETWEEN TREATMENTS. AT THE END OF THE LAST TREATMENT, THE PATIENT'S HEART RATE SLOWED. IT WAS NOTED THAT THE PATIENT ALREADY HAD A SLOW HEART RATE, THEREFORE TEMPORARY PACER WAS PLACED AT THE BEGINNING AND PACER SETTING WERE ESTABLISHED AT THE BEGINNING. THE PACER KICK

  Patient problems: Ischemia; Non specific EKG/ECG Changes; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24709227 ↗
• InjuryMar 18, 2026Entrapment of Device; Material Separation; Unexpected Shutdown

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT SEVERELY CALCIFIED, SEVERELY ANGULATED LEFT MAIN (LM) INTO THE LEFT CIRCUMFLEX (CX). A WORKHORSE WIRE WAS PLACED DOWN THE CX AND EXCHANGED FOR A VIPERWIRE GUIDE WIRE USING AN UNSPECIFIED MICROCATHETER. TWO LOW SPEED TREATMENTS WERE PERFORMED. DURING THE THIRD TREATMENT, THE OAD CROWN WAS MOVING RETROGRADE AND BECAME TRAPPED IN THE MID CX. THE PHYSICIAN ATTEMPTED TO USE GLIDEASSIST MODE TO FREE THE OAD, HOWEVER, THIS WAS UNSUCCESSFUL. THE OAD WAS THEN STARTED ON LOW SPEED, BUT THIS WAS UNSUCCESSFUL AND THE OAD STALLED. UPON FURTHER ANGIOGRAPHIC INSPECTION, IT WAS NOTED THE OAD DRIVESHAFT HAD FRACTURED AT THE PROXIMAL EDGE OF THE OAD CROWN. A SECOND WIRE WAS PLACED DOWN THE VESSEL, AND AN UNSPECIFIED 1.25 BALLOON WAS INFLATED SEVERAL TIMES TO ENTRAP THE FRACTURED COMPONENT. THE VIPERWIRE WAS PULLED BACK TO THE TIP OF THE OAD AND THE GUIDE CATHETER WAS ADVANCED TO THE OSTIUM OF THE CIRCUMFLEX. ALL COMPONENTS WERE REMOVED AND NOTHING REMAINED IN-VIVO. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION. IT WAS INDICATED THE FRACTURE MOST LIKE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24626698 ↗
• DeathMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT ON TWO LOW SPEED TREATMENTS AND ONE HIGH SPEED TREATMENT ON A LEFT ANTERIOR DESCENDING ARTERY (LAD) AND TWO LOW SPEED TREATMENTS AND ONE HIGH SPEED TREATMENT ON A MODERATELY CALCIFIED RIGHT CORONARY ARTERY (RCA). SLOW FLOW WAS OBSERVED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) POST ATHERECTOMY. THERE WERE NO ISSUES WITH THE OAD OBSERVED. THE PATIENT EXPIRED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24483654 ↗
• InjuryFeb 13, 2026Entrapment of Device; Difficult to Remove; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT 80% STENOSED MILDLY TORTUOUS HEAVILY CALCIFIED MID RCA, DURING PROCEDURE TO TREAT MID RCA, THREE TREATMENTS WERE PERFORMED USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). DURING THIRD TREATMENT, THE OAD STALLED AND STOPPED SPINNING. THE LIGHTS ON THE OAD WERE ON. THE OAD WAS STUCK IN THE LESION. THE PHYSICIAN ATTEMPTED TO USE GLIDE ASSIST, AND THE OAD SPUN FOR A SECOND AND THEN STOPPED. ACCESS WAS GAINED VIA THE GROIN AND THE PHYSICIAN BALLOONED THE LESION. THE OAD WAS PULLED AND REMOVED. FLOW LIMITING DISSECTION WAS OBSERVED AND A STENT WAS PLACED. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 24335336 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING 5 LOW-SPEED TREATMENTS WITH THE DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD) PROXIMAL DISSECTION OF THE LAD WAS NOTICED ALONG WITH NO FLOW THROUGH THE VESSEL. THE OAD WAS REMOVED. FLOW WAS RESTORED WHEN THE PHYSICIAN STARTED PLACING STENTS. THE PHYSICIAN PLACED THE FIRST STENT WHERE THE KNOWN LESION WAS LOCATED. AT THAT TIME THE FLOW WAS RESTORED TO THE PROXIMAL VESSEL. THE PHYSICIAN THEN BEGAN PLACING STENTS DISTAL TO THE FIRST STENT WHEN FLOW WAS EVENTUALLY RESTORED. A TOTAL OF 5 MEDIUM-LENGTH STENTS WERE USED TO TREAT THE DISSECTION. THE PATIENT WAS STABLE. IN THE OPINION OF THE PHYSICIAN THE NO FLOW WAS DUE TO THE DISSECTION OF THE LAD CAUSED BY THE OAD.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24327216 ↗
• DeathFeb 6, 2026Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A SEVERELY CALCIFIED MODERATELY-TO-SEVERELY TORTUOUS CIRCUMFLEX ARTERY. A VIPERWIRE FLEX TIP CORONARY GUIDEWIRE PASSED WAS ADVANCED DOWN INTO CIRCUMFLEX. THE OAD WAS ADVANCED AND ATTEMPTED TO BE SPUN, BUT COULD NOT CROSS THE LESION DUE TO CALCIUM. DURING THIS TIME, THE VIPERWIRE GUIDEWIRE RETRACTED BACK INTO THE OAD AND GOT STUCK WITHIN THE OAD. THE OAD WAS UNABLE TO BE SPUN. THE OAD WAS SWITCHED TO GLIDEASSIST MODE TO HELP SPIN OUT BUT, AT THAT POINT, WITH THE VIPERWIRE GUIDEWIRE BEING STUCK IN THE OAD CROWN, THE VIPERWIRE GUIDEWIRE SHEARED OFF. A NON-ABBOTT GUIDEWIRE WAS INSERTED INTO THE CIRCUMFLEX TO MAINTAIN ACCESS, HOWEVER, THE OAD WAS UNABLE TO BE REMOVED FROM THE PATIENT. IN THE PHYSICIAN'S OPINION, IT WAS LIKELY THE OAD CROWN WENT OUTSIDE OF THE VESSEL AND CAUSED A PERFORATION. THE PHYSICIAN DID NOT WANT TO CONTINUE TO PULL THE OAD TO WORSEN THE ISSUE. PERICARDIAL EFFUSION DEVELOPED, PERICARDIAL CENTESIS WAS PERFORMED AND 100CC OF BLOOD WAS REMOVED TO RESOLVE THE PERFORATION. THE OAD REMAINED IN THE PATIENT WHILE WAITING FOR THE PATIENT TO BE TRANSFERRED TO ANOTHER HOS

  Patient problems: Myocardial Infarction; Perforation of Vessels; Pericardial Effusion

  MAUDE report 24279186 ↗
• DeathFeb 3, 2026Failure to Advance

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT A SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA) WITH 7FR RIGHT GROIN ACCESS, MULTIPLE GUIDES WERE USED TO ENGAGE THE VESSEL PROPERLY. A 7FR 3DRC WAS USED WITH 6FR NON-ABBOTT EXCHANGE CATHETER. A TEMPORARY PACEMAKER PLACED AS THE PATIENT WENT INTO SECOND DEGREE HEART BLOCK PRIOR TO WIRING THE VESSEL. THE VESSEL WAS WIRED WITH A ABBOTT WHISPHER MS GUIDEWIRE AND A NON-ABBOTT CATHETER WAS PLACED DOWN THE VESSEL TO EXCHANGE OUT FOR VIPERWIRE CORONARY GUIDEWIRE. BOTH 6FR NON-ABBOTT EXCHANGE CATHETER AND ANOTHER NON-ABBOTT CATHETER WERE REMOVED. A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED AND FIRST TREATMENT ON LOW SPEED (80K RPM) WAS COMPLETED WITH POOR TECHNIQUE. THE PHYSICIAN CORRECTED FOR SPEED AND TWO MORE TREATMENTS WERE COMPLETED ON LOW SPEED WITH BETTER TECHNIQUE. AN ATTEMPT WAS MADE TO GLIDE ASSIST THE DEVICE DOWN TO TREAT MORE DISTAL VESSEL, BUT IT WAS UNABLE TO CROSS DUE TO PATIENT ANATOMY. THE OAD WAS PULLED BACK INTO GUIDE AND PERFORATION WAS NOTED. THE OAD WAS REMOVED, AND NON-ABBOTT EXCHANGE CATHETER WAS PLACED BACK IN AND 2.5X15 NC BALLOON WAS IMMEDIATELY PUT IN AND INFLATED. ECHO WAS CALLED AND A

  Patient problems: Perforation of Vessels

  MAUDE report 24248683 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 99% STENOSED NON TORTUOUS RIGHT CORONARY ARTERY (RCA) WITH MULTIPLE CALCIFIED LESIONS. A TEMPORARY PACER WAS USED DURING THE PROCEDURE. FOUR LOW-SPEED TREATMENTS WERE PERFORMED PROXIMAL-TO-DISTAL AND FOLLOWING THE FOURTH TREATMENT, ELECTROCARDIOGRAM (EKG) CHANGES WERE NOTED AND PATIENT EXPERIENCED CHEST PAIN. A PERFORATION WAS OBSERVED. BALLOON TAMPONADE WAS PERFORMED TO MINIMIZE THE PERFORATION AND A COVERED STENT WAS PLACED IN THE AREA TO RESOLVE THE PERFORATION. ELECTROCARDIOGRAM CONFIRMED NO CARDIAC TAMPONADE. ACCORDING TO THE PHYSICIAN, THE ORBITAL ATHERECTOMY SYSTEM DID NOT CAUSE PERFORATION AND PERFORATION HAD CAUSED CHEST PAIN. THE CHEST PAIN RESOLVED AFTER THE TAMPONADE OF THE RCA. THE PATIENT WAS STABLE.

  Patient problems: Angina; Non specific EKG/ECG Changes; Perforation of Vessels

  MAUDE report 24211533 ↗
• InjuryDec 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ATHERECTOMY PROCEDURE IN A HIGHLY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY (RCA), THE VIPERWIRE CORONARY ADVANCE FLEXTIP GUIDEWIRE WAS POSITIONED WELL DISTAL TO THE CROWN, AND THE PROCEDURE WAS BEING PERFORMED SLOWLY WITH THE APPROPRIATE PAUSES. DUE TO THE SEVERE TORTUOSITY AND CALCIFICATION OF THE ARTERY, THE GUIDEWIRE FRACTURED, AND THE RADIOPAQUE TIP DETACHED AND MIGRATED DISTALLY IN THE ARTERY. THREE TREATMENTS WERE PERFORMED PRIOR TO GUIDEWIRE FRACTURE. IN ADDITION, PART OF THE CROWN OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) DETACHED AND MIGRATED INTO THE BLOODSTREAM. THE ENTIRE TIP OF THE OAD FRACTURED. THE PHYSICIAN REMOVED THE SYSTEM FROM THE PATIENT AND REPAIRED THE LESION WITH A STENT. AFTER THE LESION WAS TREATED, AN ATTEMPT WAS MADE TO CAPTURE THE WIRE TIP USING A SNARE, AND LATER BY APPLYING TORQUE WITH ANOTHER WIRE TO TRY TO COIL AND RETRIEVE IT INTO THE CATHETER. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS, THE RADIOPAQUE TIP OF THE VIPERWIRE WAS LEFT IN-VIVO TO AVOID ARTERIAL INJURY OR A POTENTIAL PERFORATION THAT COULD OCCUR IF OTHER RETRIEVAL METHODS WERE USED. THE PHYSICIAN LEFT THE RADIOOPAQUE TIP OF THE GUI

  Patient problems: Foreign Body In Patient

  MAUDE report 23789649 ↗
• DeathNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) PERFORMED 10 LOW-SPEED TREATMENTS IN THE SEVERELY CALCIFIED, DIFFUSE, MILDLY TORTUOUS RIGHT CORONARY ARTERY (RCA). FOLLOWING ATHERECTOMY, A 2.5 X 15MM SAPPHIRE NC24 PTCA BALLOON WAS USED TO PERFORM BALLOON ANGIOPLASTY. ANGIOGRAPHIC IMAGES TAKEN POST BALLOON ANGIOPLASTY SHOWED PERFORATION. TWO COVERED STENTS WERE DEPLOYED. THE PATIENT EXPERIENCED HYPOTENSION AND WAS INTUBATED. THE PATIENT WAS UNSTABLE AND REMAINED IN THE HOSPITAL. PER THE OPINION OF THE PHYSICIAN THE OAD LIKELY CONTRIBUTED TO THE PERFORATION. THEY SUSPECT THE PERFORATION LIKELY OCCURRED DURING BALLOON ANGIOPLASTY BUT EXACT CAUSE COULD NOT BE CONFIRMED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 23610012 ↗
• DeathOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) AND VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WERE BEING USED TO TREAT HEAVILY CALCIFIED, SEVERELY TORTUOUS, 90% STENOSED LESION IN PROXIMAL CIRCUMFLEX ARTERY (CFX). THE LESION WAS PRIMARILY WIRED WITH THE VIPERWIRE. A 6FR GUIDE EXTENSION CATHETER WAS IN USE DURING THE PROCEDURE. THREE LOW-SPEED TREATMENTS WITH THE OAD WERE PERFORMED. IT WAS NOTICED THE PATIENT FELT GENERALLY UNWELL, DIAPHORETIC, AND NAUSEOUS. CONTRAST DYE WAS INJECTED FOR POST-RUN CHECK AND A PERFORATION WAS OBSERVED IN THE PROXIMAL CFX NEAR THE AREA TREATED. THE OAD CROWN DID NOT JUMP. THE OAD WAS REMOVED. A NON-ABBOTT SEMI-COMPLIANT BALLOON WAS DILATED IN THE PERFORATED AREA IN AN ATTEMPT TO RESOLVE THE PERFORATION BUT WAS UNSUCCESSFUL. TWO NON-ABBOTT COVERED STENTS WERE PLACED TO COVER THE PERFORATION. PERICARDIOCENTESIS WAS ALSO PERFORMED TO DRAIN FLUID. THE PATIENT DECOMPENSATED. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. TOWARD THE END OF THE CPR THE PATIENT WAS INTUBATED. A SECOND PERFORATION WAS NOTED IN THE LAD. UPON RETURN OF SPONTANEOUS CIRCULATIO

  Patient problems: Cardiac Arrest; Diaphoresis; Low Blood Pressure/ Hypotension; Nausea; Perforation of Vessels

  MAUDE report 23439815 ↗
• DeathOct 24, 2025Difficult to Remove; Unexpected Shutdown; Difficult to Remove; Unexpected Shutdown

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED THROUGH FEMORAL ACCESS IN AN ATTEMPT TO TREAT HEAVILY CALCIFIED, MILDLY TORTUOUS, 90% STENOSED LESIONS IN LEFT ANTERIOR DESCENDING ARTERY (LAD) AND LEFT MAIN ARTERY (LM). THE ESTIMATED VESSEL DIAGRAM BASED ON ANGIOGRAM WAS 2.5MM-3.0MM; NO INTRACORONARY IMAGING WAS DONE PRIOR TO ORBITAL ATHERECTOMY. A HEART PUMP WAS INSERTED PRIOR TO THE PROCEDURE. AN EBU 9 (EXTRA BACK-UP) 3.75 7FR GUIDE CATHETER WAS IN USE. THE LESION WAS PRIMARY WIRED WITH A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. THE OAD WAS TESTED EX VIVO PRIOR TO ADVANCING IN VIVO. THE OAD WAS ADVANCED TO THE PROXIMAL END OF THE LESION IN LAD FOR THE FIRST TREATMENT. ONE PROXIMAL-TO DISTAL LOW-SPEED TREATMENT AND ONE DISTAL-TO-PROXIMAL LOW-SPEED TREATMENT WERE PERFORMED. AT THIS TIME, THE PHYSICIAN ELECTED TO USE GLIDEASSIST TO RETRACT THE OAD, HOWEVER, THE OAD WAS NOT MOVING AND IT FELT AS IF THE OAD AND THE VIPERWIRE WERE FUSED TOGETHER. IT WAS FURTHER EXPLAINED AS THE OAD APPEARING TO HAVE LOCKED OUT WHEN IN THE CALCIUM. FLASHING LIGHT ON THE OAD SHOWED THE OAD STALL LOCKOUT. AFTER WAITING FOR 5 SECONDS THE

  Patient problems: Arrhythmia; Cardiac Arrest; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Pain; Perforation of Vessels; Pericardial Effusion; Vascular Dissection

  MAUDE report 23381081 ↗
• MalfunctionOct 20, 2025Unintended System Motion; Device Damaged by Another Device; Unintended System Motion; Device Damaged by Another Device

  IT WAS REPORTED THAT A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF DIFFUSE, LONG, 360-DEGREE/HEAVILY CALCIFIED, NON-TORTUOUS, 90% STENOSED LESION IN MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-ABBOTT GUIDE WIRE WAS EXCHANGED FOR A VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP. THERE WAS NO DIFFICULTY WIRING OR DELIVERING DEVICES. THERE WAS NO WIRE BIAS. TWO LOW-SPEED TREATMENTS WERE PERFORMED. DURING THE THIRD TREATMENT WHICH WAS AT LOW SPEED, THERE WAS NO SUPPORT AND AN UNSPECIFIED GUIDE KEPT ON COMING BACK A LITTLE BIT. WHEN THE GUIDE STARTED PULLING BACK IT PULLED THE VIPERWIRE WITH IT AND THAT¿S WHEN THE OAD CROWN CROSSED THE LESION AND JUMPED FORWARD AND SHEARED OFF THE VIPERWIRE RADIOPAQUE SPRING TIP. THE FRAGMENT REMAINED IN DISTAL LAD. AS THE PHYSICIAN BELIEVED SNARING THE FRAGMENT WOULD HAVE BEEN MORE HARMFUL A STENT WAS USED TO PIN THE FRAGMENT ON THE ARTERY WALL IN DISTAL LAD AND A SECOND STENT PLACEMENT WAS PERFORMED IN MID LAD TO FINISH TREATING IT. THERE WERE NO FURTHER COMPLICATIONS. THE PATIENT WAS STABLE AND DISCHARGED AS PLANNED. THE PHYSICIAN DOES NOT HAVE ANY CONCERNS ABOUT POTENTIAL LONG-TERM RISK OUT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336844 ↗
• MalfunctionOct 17, 2025Unintended System Motion; Device Damaged by Another Device; Unintended System Motion; Device Damaged by Another Device

  IT WAS REPORTED A DIAMONDBACK 360 PRECISION CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN MID CIRCUMFLEX ARTERY (CFX) THROUGH FEMORAL ARTERY ACCESS USING 6 FR GUIDE CATHETER WHICH WAS INSERTED TO THE LEFT MAIN ARTERY (LM) AND CANNULATED. ANTICOAGULATION WAS STARTED. THE VIPERWIRE ADVANCE CORONARY GUIDE WIRE WITH FLEX TIP WAS ADVANCED WITHOUT RESISTANCE THROUGH THE LESION IN THE MID CFX AND THE RADIOPAQUE TIP WAS POSITIONED IN MID OBTUSE MARGINAL ARTERY (OM1). THE VESSEL WAS PRIMARILY WIRED WITH VIPERWIRE. THERE WAS MODERATE WIRE BIAS. THE OAD WAS PREPARED AND ADVANCED ON GLIDEASSIST INTO THE VESSEL. THE METHOD OF TREATMENT DUE TO CALCIFICATION AND TORTUOSITY WAS RETROGRADE. THE CROWN WAS ADVANCED PAST THE LESION AND POSITIONED DISTAL TO THE LESION. THE FIRST TREATMENT, WHICH WAS ON LOW SETTING, WAS SUCCESSFUL WITH NO ISSUES AND ONE-TO-ONE MOTION WAS IDENTIFIED. TO PERFORM A SECOND TREATMENT, GLIDEASSIST WAS AGAIN USED TO CROSS THE LESION TO REMOVE COMPRESSION BUILD UP AND ENSURE SMOOTH TRANSITION ACROSS THE LESION. MOTION WAS IDENTIFIED AS ONE-TO-ONE WHILE USING GLIDEASSIST FOR THE SECOND TREATMENT. THE VIPERWIRE WAS NOTED ON ANGIOGRAM TO BE MIDWAY D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327819 ↗