Diamondback Peripheral DBP-200SOLID145Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10850000491202), received between Jul 16, 2020 and Jul 27, 2026 — classified as 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Unexpected Shutdown

  It was reported that during procedure to treat right superficial femoral artery (SFA) using a Diamondback 360 Peripheral Orbital Atherectomy Device (OAD), after several treatments on low and medium speed, the device shut down due to what was believed to be dissection. The physician ensured the Viperwire guidewire and OAD handle were all straight, and ran the device again but the same issue occurred. It was noted that there might be a dissection the crown was getting caught in. The device was removed from the body. There was no dissection noted prior to using OAD. Type A dissection was observed when the picture was taken after the OAD was removed, and percutaneous transluminal angioplasty (PTA) was done. The procedure was completed using non-Abbott intravascular lithotripsy (IVL), PTA, and use of non-Abbott stents to treat dissection. The patient was stable.

  Patient problems: Vascular Dissection

  MAUDE report 50039229 ↗
• InjuryJun 1, 2026Entrapment of Device; Difficult to Remove

  IT WAS REPORTED A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. IT WAS INDICATED THE OAD AND VIPERWIRE WERE STUCK TOGETHER, AND THE OAD WAS STUCK IN THE VESSEL. THE PHYSICIAN WAS UNABLE TO REMOVE THE OAD AND VIPERWIRE FROM EACH OTHER. THIS OCCURRED AFTER ORBITAL ATHERECTOMY TREATMENT WAS COMPLETE AND THE DEVICES WERE ATTEMPTED TO BE REMOVED. A NON-ABBOTT GUIDE WIRE AND A NON-ABBOTT BALLOON WERE INSERTED TO ASSIST WITH DISLODGING THE OAD FROM THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PROCEDURE WAS CONSIDERED SUCCESSFUL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25350491 ↗
• InjuryNov 27, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN WAS AWARE THAT OAS IS CONTRAINDICATED FOR USE IN THE SUBINTIMAL SPACE. IN THE PHYSICIAN'S OPINION, THE PERFORATION WAS CAUSED BY ORBITAL ATHERECTOMY.

  Patient problems: Perforation of Vessels

  MAUDE report 20803004 ↗
• InjurySep 26, 2024Entrapment of Device; Device Contaminated at the User Facility; Entrapment of Device; Device Contaminated at the User Facility

  THE PHYSICIAN TOOK IMAGING OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) PRIOR TREATMENT. THE VESSEL WAS WIRED AND BALLOONED. THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 80-90% DIFFUSE, DISEASED SFA. TWO OR THREE TREATMENTS OF 20 SECONDS WERE PERFORMED WITH FLUSHING IN BETWEEN. THE OAD WAS ATTEMPTED TO BE REMOVED, BUT THERE WAS RESISTANCE. THE OAD WAS STUCK IN TISSUE RIGHT ABOVE THE SHEATH. THE PHYSICIAN BELIEVED THE ACCESS SHEATH WAS KINKED. ALL PRODUCTS WERE REMOVED EX-VIVO AND PRESSURE WAS APPLIED. POPLITEAL PULSE WAS PALPABLE, AS WELL AS DISTAL PULSES. THE PATIENT WAS IN STABLE CONDITION. UPON REMOVAL OF THE OAD, THERE WAS TISSUE WRAPPED AROUND THE CROWN AND CATHETER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20310100 ↗
• InjurySep 18, 2024Unexpected Shutdown; Unexpected Shutdown

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). TWO TREATMENTS WERE PERFORMED BEFORE THE OAD MADE A SOUND AND STOPPED SPINNING. THE YELLOW LED LIGHT WAS DISPLAYING AT THE TIME THE DEVICE STOPPED SPINNING. A SECOND ATTEMPTED TREATMENT WAS PERFORMED AFTER THE OAD STOPPED SPINNING, AND THE SAME RESULT OCCURRED. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE. AN EXTRAVASATION WAS OBSERVED, AND A COVERED STENT WAS PLACED TO RESOLVE THE ISSUE. IN THE PHYSICIAN'S OPINION, THE OAD ENTERED SOFT PLAQUE WHICH LED TO THE ADVERSE EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 20249106 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT AN 80% STENOSED, MODERATELY CALCIFIED LESION IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA). ALL THREE SPEEDS WERE USED TO TREAT THE LESION AND THE ANGIOGRAPHIC RESULT WAS SATISFACTORY. UPON OBSERVING FINAL RUNOFF ANGIOGRAMS, A BLOCKAGE WAS OBSERVED IN THE PATIENT'S DORSALIS PEDIS (DP) ARTERY THAT WAS NOT PRESENT DURING THE FIRST ANGIOGRAM. AN ASPIRATION CATHETER WAS USED TO REMOVE A PIECE OF PLAQUE OR TISSUE. THE PHYSICIAN DESCRIBED IT AS ATHEROMA. FULL FLOW WAS ESTABLISHED AFTER REMOVING THE PIECE OF PLAQUE/TISSUE. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Embolism/Embolus

  MAUDE report 16787491 ↗
• MalfunctionMar 24, 2023Material Separation; Material Separation

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE COMMON FEMORAL ARTERY. THE DEVICE WAS RETRACTED TO THE LESION IN THE COMMON ILIAC ARTERY. TWO TREATMENTS ON LOW SPEED WERE PERFORMED. WHEN CHANGING THE SPEED TO MEDIUM, THE OAD STOPPED SPINNING. THE OAD WAS DIFFICULT TO REMOVE AND SEEMED TO BE STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE. THE OAD AND GUIDE WIRE WERE REMOVED. DAMAGE WAS OBSERVED ON THE DRIVESHAFT NEAR THE CROWN. A NEW GUIDE WIRE WAS USED AND THE PROCEDURE WAS COMPLETE WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612264 ↗
• MalfunctionMar 2, 2023Entrapment of Device; Detachment of Device or Device Component

  LEFT FEMORAL ARTERY WAS ACCESSED FOR THE PROCEDURE. DURING THE INSERTION OF THE CSI ORBITAL ATHERECTOMY DEVICE THE TIP OF THE DEVICE EMBOLIZED IN THE RIGHT COMMON FEMORAL REQUIRING SNARING OF THE TIP. ALL PIECES WERE REMOVED AND NO HARM NOTED TO PATIENT.

  Patient problems: Foreign Body Embolism

  MAUDE report 16467118 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A LESION THAT WAS 40 MM IN LENGTH, 5 MM DIAMETER, AND 80% STENOSED AT THE JOINT LINE IN THE POPLITEAL ARTERY. THE PATIENT EXPERIENCED PERSISTENT SLOW FLOW, AND IMAGING REVEALED THROMBUS. AN INFUSION CATHETER WAS QUICKLY INSERTED TO PROVIDE OVERNIGHT TISSUE PLASMINOGEN ACTIVATOR (TPA) ALONG WITH A HEPARIN DRIP. THE FOLLOWING DAY, COVERED STENT PLACEMENT WAS PERFORMED IN THE LOCATION ATHERECTOMY HAD BEEN INITIALLY PERFORMED. FLOW WAS STRONG TO THE DORSALIS PEDIS ARTERY. THE PATIENT WAS STABLE.

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

  MAUDE report 15683572 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CALCIFIED EXTERNAL ILIAC LESION, NEAR CHRONIC TOTAL OCCLUSION (CTO). THE VESSEL ANATOMY WAS NORMAL, NOT VERY TORTUOUS NOR WERE THERE TIGHT CURVES. A TREATMENT WAS PERFORMED ON LOW-SPEED WHEN THE PATIENT EXPERIENCED PAIN. ANGIOGRAPHY REVEALED NO ISSUES. IN THE OPINION OF THE PHYSICIAN, THE SECOND TREATMENT, WHICH WAS PERFORMED ON MEDIUM SPEED, LED TO A PERFORATION OF THE VESSEL. THE PHYSICIAN BELIEVED THE OAD BECAME SUBINTIMAL DURING THE SECOND TREATMENT. BALLOON ANGIOPLASTY WAS USED TO CONTROL THE PERFORATION, AND AN UPSIZED SHEATH WAS USED TO DELIVER A COVERED STENT FROM THE EXTERNAL ILIAC ARTERY TO THE COMMON ILIAC ARTERY. A SECOND STENT WAS EVENTUALLY PLACED, AND ANOTHER DISSECTION OCCURRED. DURING THIS INTERVENTION, THE PATIENT EXPERIENCED HYPOTENSION, WHICH WAS MANAGED WITH MEDICATION. THE PATIENT REQUIRED AN ADDITIONAL SURGERY AND REMAINED HOSPITALIZED TEN DAYS POST PROCEDURE IN STABLE CONDITION.

  Patient problems: Intraoperative Pain; Low Blood Pressure/ Hypotension; Perforation of Vessels; Vascular Dissection

  MAUDE report 15498479 ↗
• MalfunctionSep 22, 2022Difficult to Remove; Difficult to Remove

  FOLLOWING TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY, THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL UPON REMOVAL. THE OAD WAS TURNED ON AND PULLED RETROGRADE. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463313 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER A TREATMENT IN A 6 MM, TOTALLY OCCLUDED LESION FROM THE MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) ON LOW SPEED, MEDIUM SPEED, AND HIGH SPEED, USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THE CROWN STOPPED SPINNING. THE CROWN WAS TEMPORARILY STUCK. USING THE ADVANCER KNOB, THE DEVICE WAS RETRACTED AND REMOVED FROM THE BODY. A PERFORATION IN THE SFA WAS NOTICED. THE PERFORATION WAS RESOLVED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS RESPONSIVE WITH GOOD FLOW TO THE FOOT.

  Patient problems: Perforation of Vessels

  MAUDE report 15294250 ↗
• InjuryApr 22, 2022Material Separation; Material Separation

  A DIAMONDBACK GEN 2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE PERONEAL ARTERY. THE 3.5MM VESSEL WAS 90% STENOSED, WITH CALCIFICATION. THE OAD BUCKLED NEAR THE DISTAL END OF THE CROWN AFTER ONE-TO-ONE MOTION WAS LOST. IMAGING INDICATED THE NOSE OF THE OAD HAD SEPARATED FROM THE CROWN. FURTHER IMAGING CONFIRMED THE NOSE OF THE OAD AND A PORTION OF THE GUIDEWIRE HAD FRACTURED. THE OAD AND WIRE WERE REMOVED FROM THE PATIENT. ATTEMPTS TO RETRIEVE THE OAD NOSE AND WIRE FRAGMENT WERE MADE. THE NOSE OF THE OAD WAS COVERED WITH PLACEMENT OF A COVERED STENT. PERONEAL ACCESS WAS OBTAINED, AND THE PHYSICIAN WAS ABLE TO SNARE THE WIRE FRAGMENT AND REMOVE IT FROM THE PATIENT. THE PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE. HOWEVER, THE PATIENT'S LOWER EXTREMITY HAD BECOME SWOLLEN, AND HIGH PRESSURES WERE NOTED. THE PATIENT REQUIRED A FASCIOTOMY. FOLLOWING THE FASCIOTOMY, THE PATIENT WAS STABLE AND AWAITING DISCHARGE. IN THE OPINION OF THE PHYSICIAN, THE SPECIFIC CAUSE OF THE ADVERSE EVENT WAS DEVICE ENTRAPMENT AND PROLONGED SHEATH PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14189472 ↗
• InjuryApr 13, 2022Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA LEFT COMMON FEMORAL (CFA) ACCESS AND CONTRALATERAL APPROACH. A 6FR SHEATH WAS USED. ATHERECTOMY WAS PLANNED FOR A RIGHT CFA LESION. A VIPERWIRE WAS USED TO WIRE THE VESSEL, AND A NON-CSI FILTER WAS DEPLOYED IN THE PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA). THE OAD WAS THEN ADVANCED, AND ATHERECTOMY WAS PERFORMED WITHOUT ISSUE. DURING REMOVAL THE OAD CROWN BECAME ENTRAPPED IN THE RIGHT EXTERNAL ILIAC ARTERY. (THIS LESION HAD NOT APPEARED ANGIOGRAPHICALLY SIGNIFICANT.) THE SHEATH WAS ABOVE/PROXIMAL TO WHERE THE CROWN HAD BECOME ENTRAPPED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE OAD. THE OAD COULD BE ACTIVATED, BUT IT WOULD STALL EACH TIME. A NON-CSI WIRE WAS ADVANCED TO AID IN REMOVAL OF THE OAD. IN THE OPINION OF THE PHYSICIAN , THE PATIENT'S ANATOMY WAS THE CAUSE OF THE OAD BECOMING ENTRAPPED. THE FILTER BECAME ENTRAPPED AT THE SAME LOCATION LATER IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102586 ↗
• MalfunctionMar 31, 2022Material Separation; Material Separation

  A DIAMONDBACK GEN 2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE COMMON FEMORAL ARTERY (CFA) VIA CONTRALATERAL ACCESS. TORTUOSITY WAS MINIMAL, AND THE LESION WAS HEAVILY CALCIFIED. THE STENOSIS EXTENDED INTO THE SUPERFICIAL FEMORAL ARTERY, WHICH WAS CHRONICALLY OCCLUDED; THERE WAS PRE-EXISTING NO FLOW AFTER THE CFA AND PROFUNDA. STENOSIS WAS 90%. TWO LOW-SPEED TREATMENTS WERE PERFORMED, FOLLOWED BY TWO MEDIUM-SPEED TREATMENTS, AND A HIGH-SPEED TREATMENT. DURING THE SECOND HIGH-SPEED TREATMENT, AN UNEXPECTED AUDIBLE NOISE WAS OBSERVED, AND THE OAD BECAME STUCK ON THE GUIDEWIRE. AT THIS TIME THE PHYSICIAN WAS NOT SURE IF THE OAD WAS STUCK ON THE WIRE OR STUCK IN A DISSECTION PLANE. THE PHYSICIAN WAS ABLE TO REMOVE THE OAD AND WIRE TOGETHER, AND IT WAS THEN NOTED THE WIRE HAD FRACTURED AND THE FRAGMENT REMAINED IN THE TIP BUSHING OF THE OAD. THE VESSEL WAS REWIRED, AND THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. THE PHYSICIAN WAS CONFIDENT THERE WERE NO FRAGMENTS LEFT IN VIVO. DEVICE ANALYSIS DETERMINED THE FRACTURED COMPONENT WAS A DRIVESHAFT FILAR AS OPPOSED TO A GUIDEWIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13966411 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF DISEASE IN THE COMMON FEMORAL ARTERY (CF) AND SUPERFICIAL FEMORAL ARTERY (SFA). TREATMENT WAS INTENTIONALLY PLANNED FOR THE DISTAL TWO THIRDS OF THE SFA, WHERE A PREEXISTING STENT WAS IMPLANTED. THE STENTED AREA WAS DISEASED THROUGHOUT WITH A FOCAL AREA IN THE CENTER. THE STENTS APPEARED TO BE 6.0MM IN DIAMETER, AND A 2.0MM CROWN WAS USED. THE TREATMENT AREA APPEARED TO BE ABOUT 300MM IN LENGTH. ONE TREATMENT PASS EACH WAS PERFORMED ON LOW AND MEDIUM SPEEDS FOLLOWED BY TWO HIGH SPEED TREATMENTS IN THE DISTAL HALF OF THE TARGET AREA. THE SAME SEQUENCE WAS REPEATED FOR THE PROXIMAL HALF OF THE STENT. APPROPRIATE REST TIMES WERE OBSERVED BETWEEN TREATMENTS. TREATMENT WAS THEN PERFORMED IN THE CF THROUGH THE PROXIMAL SFA WHERE NO PREEXISTING STENT WAS. IMAGING THEREAFTER REVEALED SLOW FLOW THROUGH THE VESSEL. A DRUG COATED BALLOON WAS USED TO TREAT THE CF THROUGH PROXIMAL SFA. TREATMENT WAS SUCCESSFUL. IMAGING THEREAFTER REVEALED NO FLOW IN THE PROXIMAL SFA AND DISTAL. A CATHETER WAS ADVANCED INTO THE VESSEL, AND THE DISTAL POPLITEAL APPEARED TO BE BLOCKED. THE BLOCKAGE APPEARED TO BE THROMBUS. WHEN THE

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

  MAUDE report 13403620 ↗
• InjuryNov 30, 2021Entrapment of Device; Entrapment of Device

  FOLLOWING TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE PHYSICIAN RETRACTED THE DEVICE FOR REMOVAL. RESISTANCE WAS ENCOUNTERED DURING REMOVAL, AND THE OAD COULD NOT BE RETRACTED COMPLETELY. THE CROWN WAS ADVANCED TO RELIEVE THE RESISTANCE. FLUOROSCOPY WAS THEN USED DURING CONTINUED ATTEMPTS TO RETRACT THE DEVICE. THE CROWN WAS RETRACTED AND BECAME ENTRAPPED IN THE DISTAL PORTION OF THE INSERTION SHEATH. A TECHNICIAN PULLED ON THE DEVICE TO BRING IT BACK, AND THE PHYSICIAN PULLED ON THE DRIVESHAFT. THE OAD THEN CAME FREE AND WAS EXTRACTED FROM THE PATIENT. HOWEVER, A 15CM PORTION OF THE DRIVESHAFT AND CROWN REMAINED IN THE DISTAL PORTION OF THE SHEATH. THE FRAGMENT PROTRUDED FROM THE HUB OF THE SHEATH. THE PHYSICIAN PULLED THE FRAGMENT OUT. ANGIOGRAM THEN REVEALED A TYPE C DISSECTION IN THE SFA. THE DISSECTION WAS IN THE AREA OF ATHERECTOMY TREATMENT. THE PROCEDURE WAS COMPLETED AND THE DISSECTION WAS RESOLVED WITH PRE-PLANNED ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 12900545 ↗
• MalfunctionNov 30, 2021Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  THE SALINE TUBING OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DISCONNECTED DISTAL TO THE BLACK POSITIONERS. ONE OA TREATMENT WAS PERFORMED WITHOUT THE AID OF VIPERSLIDE DUE TO THE TUBING DAMAGE. THE OAD BECAME STUCK ON THE GUIDEWIRE. THE OAD AND WIRE WERE REMOVED FROM THE PATIENT. ATHERECTOMY WAS DISCONTINUED, AND THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY. THE PUMP POSITION IN THE PROCEDURE ROOM WAS DESCRIBED AS FAR AWAY FROM THE BED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12896561 ↗
• InjuryNov 24, 2021Material Separation; Material Separation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE ADVANCED VIA COMMON FEMORAL ACCESS TO THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY, WHICH WAS HEAVILY CALCIFIED. THE ILIAC BIFURCATION WAS TORTUOUS, AND DIFFICULTY WAS EXPERIENCED IN ADVANCING THE OAD ACROSS IT. THE OAD WAS BEING USED WITH A 6FR 45CM GUIDE CATHETER. THE OAD WAS REMOVED, AND THE GUIDE CATHETER WAS REPLACED WITH A 7FR CATHETER. AT THAT TIME, IT WAS NOTED THE DISTAL DRIVESHAFT AND CROWN HAD FRACTURED ON THE PROXIMAL EDGE OF THE CROWN. THE FRAGMENT WAS SNARED. DIRECTIONAL ATHERECTOMY WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12869106 ↗
• MalfunctionOct 1, 2021Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  SEVERAL TREATMENTS WERE ADMINISTERED WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). THE DEVICE THEN STOPPED SPINNING. THE CROWN HAD SPUN BACKWARDS INTO THE SHEATH, THEREBY CAUSING DAMAGE TO THE SHEATH AND OAD DRIVESHAFT. DIFFICULTY WAS ENCOUNTERED IN REMOVING THE OAD FROM THE GUIDE WIRE AND IN PULLING THE OAD BACK INTO THE SHEATH. A WIRE WAS INSERTED TO MAINTAIN WIRE POSITION, AND THE OAD, GUIDE WIRE, AND SHEATH WERE REMOVED. UPON FURTHER OBSERVATION, THE OAD DRIVESHAFT HAD UNRAVELED NEAR THE CROWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562073 ↗
• MalfunctionAug 10, 2021Material Separation; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT VIA FEMORAL ACCESS. DURING AN ATTEMPT TO ADVANCE THE OAD TO THE LESION, THE OAD BECAME STUCK INSIDE OF THE SHEATH AT THE AORTIC BIFURCATION. THE OAD WAS PULLED BACK, AND IT WAS OBSERVED THAT THE OAD DRIVESHAFT HAD FRACTURED DISTAL TO THE CROWN. THE FRACTURED SEGMENT WAS REMOVED WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12303385 ↗
• InjuryFeb 2, 2021Material Separation; Material Separation

  THE CROWN OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN A LESION IN THE COMMON FEMORAL ARTERY, WHICH CAUSED THE DEVICE TO STOP SPINNING. DURING REMOVAL ATTEMPTS, THE CROWN SEPARATED FROM THE OAD SHAFT. A GUIDE WIRE WAS INSERTED DISTAL TO THE CROWN AND A BALLOON WAS INFLATED NEAR THE CROWN TO FACILITATE REMOVAL OF THE CROWN AND OAD SHAFT. THE CASE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 11265365 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THROMBUS WAS OBSERVED IN THE TIBIOPERONEAL TRUNK FOLLOWING USE OF A STEALTH ORBITAL ATHERECTOMY DEVICE. THE PATIENT WAS TREATED OVERNIGHT WITH TISSUE PLASMINOGEN ACTIVATOR. THE THROMBUS WAS THEN EXTRACTED SUCCESSFULLY WITH AN ADDITIONAL NON-CSI DEVICE. THE OAD REPORTEDLY ALSO BECAME STUCK ON THE VIPERWIRE, THOUGH THAT EVENT IS NOT CONSIDERED A REPORTABLE MALFUNCTION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11197366 ↗
• InjuryJan 12, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  TWO TREATMENTS WERE ADMINISTERED IN THE RIGHT ILIAC ARTERY USING A DIAMONDBACK PLUTO PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). WHEN THE DEVICE WAS ACTIVATED FOR A THIRD TREATMENT, IT STALLED AND COULD NOT BE REMOVED. THE PHYSICIAN PULLED ON THE DEVICE, AND THE DRIVESHAFT FRACTURED ON THE PROXIMAL SIDE OF THE CROWN. ADDITIONAL ACCESS WAS OBTAINED TO SNARE THE FRAGMENT. THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT AND WITHOUT FURTHER ISSUE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11156531 ↗
• InjuryNov 20, 2020Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED WITHIN A PREVIOUSLY PLACED STENT IN THE SUPERFICIAL FEMORAL ARTERY. THE OAD WAS DIFFICULT TO REMOVE, AND UPON REMOVAL TISSUE WAS OBSERVED AROUND THE CROWN. THE STENT WAS UNDAMAGED. IMAGING WAS PERFORMED AND NO FLOW WAS OBSERVED INSIDE THE STENT IN THE AREA TREATED BY THE OAD. A BALLOON WAS INFLATED AND AN ADDITIONAL STENT WAS PLACED TO RESOLVE THE ISSUE. THE CASE WAS COMPLETED WITH A GOOD END RESULT AND THE PATIENT WAS DISCHARGED. PER THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE EVENT WAS THAT THE DEVICE WAS INADVERTENTLY PLACED SUBINTIMAL WITHIN THE IN-STENT RESTENOSIS.

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

  MAUDE report 10875126 ↗