Diamondback Peripheral DBP-125MICRO145 (REF 7-10057-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10850000491172), received between Feb 5, 2020 and Mar 24, 2026 — classified as 30 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (25 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED IN AN ATTEMPT TO TREAT HEAVILY CALCIFIED, MODERATELY TORTUOUS, 100% STENOSED POSTERIOR TIBIAL ARTERY (PTA). GLIDEASSIST MODE WAS USED IN AN ATTEMPT TO CROSS THROUGH THE PEDAL ARCH TO TREAT THE PTA, HOWEVER, THE OAD BECAME STUCK IN THE PEDAL ARCH. MULTIPLE ATTEMPTS WERE MADE TO DISLODGE THE OAD. ALL ATTEMPTS WERE UNSUCCESSFUL. OPEN ENDARTECTOMY OF THE DORSALIS PEDIA WAS PERFORMED TO FREE THE OAD. THE PATIENT WAS IN STABLE CONDITION WITH PATENT DORSALIS PEDIS. IT WAS INDICATED THE VESSEL WAS TOO SMALL FOR THE OAD AND A VASOSPASM OCCURRED, WHICH LED TO THE OAD BECOMING STUCK.

  Patient problems: Device Embedded In Tissue or Plaque; Vasoconstriction

  MAUDE report 24682157 ↗
• InjuryMar 18, 2026Entrapment of Device

  IT WAS REPORTED THAT DURING PROCEDURE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN HEAVILY CALCIFIED DISTAL RIGHT ANTERIOR TIBIAL VESSEL. THE VESSEL DIAMETER WAS 2.0-2.5 MM. AN ATTEMPT TO ENGAGE GLIDEASSIST WAS MADE, BUT DID NOT WORK. LUMINAL AND PLAQUE MORPHOLOGY WAS VERIFIED BY INTRAVENOUS ULTRASOUND. THE VESSEL WAS PREDILATED WITH A 1.5 MM JADE BALLOON AND THE PATIENT WAS SENT TO EMERGENCY ROOM. THE DEVICE WAS REMOVED DURING SURGERY. BYPASS WAS PERFORMED TO THE PERONEAL ARTERY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 24627528 ↗
• InjurySep 18, 2025Entrapment of Device; Device Contaminated at the User Facility; Entrapment of Device; Device Contaminated at the User Facility

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT HIGHLY CALCIFIED, CHRONIC TOTALLY OCCLUDED PERONEAL ARTERY THROUGH FEMORAL ARTERY ACCESS, THE CROWN OF THE 1.25MM MICRO DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL DUE TO CALCIFICATION. THE REFERENCE VESSEL DIAMETER WAS 2.5MM. THE VIPERWIRE ADVANCE GUIDE WIRE WAS MOVING FREELY BUT THE CROWN SEEMED WRAPPED/STUCK IN CALCIUM. OAD REMOVAL ATTEMPTS INCLUDING USE OF GLIDEASSIST, USE OF BUDDY WIRE WITH BALLOON TO ATTEMPT CROWN DISLODGEMENT, EXTERNAL CALF MASSAGE TO LOOSEN OAD, AND NITROGLYCERIN/VASODILATORS ADMINISTRATION WERE UNSUCCESSFUL. SURGERY WAS PERFORMED TO COMPLETELY REMOVE THE OAD. THE OAD WAS OBSERVED TO HAVE PLAQUE AND CALCIUM UPON REMOVAL. THE SURGERY WAS COMPLETELY SUCCESSFUL. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23088732 ↗
• InjuryJun 4, 2025Entrapment of Device; Device Contaminated at the User Facility; Entrapment of Device; Device Contaminated at the User Facility

  A 1.25 MICRO CROWN DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED ON LOW-SPEED FOR SUCCESSFUL TREATMENT OF A CALCIFIED, NON-TORTUOUS LESION IN RIGHT TIBIAL ARTERIES THROUGH LEFT COMMON FEMORAL ARTERY (CFA) ACCESS. THE RIGHT PEDAL LOOP WAS GOING TO BE TREATED NEXT BUT THE OAD BECAME STUCK IN THE RIGHT PEDAL LOOP. THE OAD WAS PUT ON GLIDEASSIST AND WAS TURNED ON AND OFF, HOWEVER, THE DEVICE CONTINUED TO BE STUCK IN THE VESSEL. SURGERY WAS PERFORMED TO REMOVE THE OAD WITHOUT FURTHER COMPLICATIONS. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22141135 ↗
• InjuryMay 29, 2025Entrapment of Device; Unexpected Shutdown; Entrapment of Device; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE, A NON-ABBOTT GUIDEWIRE WAS USED TO CROSS A 90% LESION LOCATED IN THE MID ANTERIOR TIBIAL (AT) ARTERY OF THE PATIENT. ONCE THE GUIDEWIRE TRAVERSED PAST THE LESION DISTALLY A NON-ABBOTT CROSSING CATHETER WAS SELECTED FOR A GUIDEWIRE EXCHANGE. THE GUIDEWIRE WAS REMOVED AND THE VIPERWIRE GUIDEWIRE WAS INSERTED. ONCE THE VIPERWIRE GUIDEWIRE WAS DELIVERED DISTALLY THROUGH THE SUPPORT CATHETER, THE SUPPORT CATHETER WAS REMOVED FOR THE DELIVERY OF THE 1.25 MICRO DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD). THE OAD WAS PRIMED AND DELIVERED OVER THE VIPERWIRE GUIDEWIRE AND ADVANCED TO THE DESIRED LOCATION OF TREATMENT. THE TREATMENT OF THE DISTAL POPLITEAL ARTERY DESCENDING INTO ANTERIOR TIBIAL ARTERY WAS PERFORMED WITH FIRST TREATMENT AT 60,000 SPEED AND THE SECOND TREATMENT AT 90,000 SPEED FOR 15 SECONDS WITH A 15 SECOND REST. THE TREATMENT WAS STOPPED AFTER TREATING THE FIRST SEGMENT OF AT ARTERY. THE CROWN WAS LOCKED AND GLIDE ASSIST WAS ACTIVATED FOR CROWN ADVANCEMENT TO THE MID SECTION OF THE AT ARTERY. THE CROWN WAS DELIVERED TO THE DESIRED LOCATION, AND TREATMENT OF MID AT ARTERY BEGAN. DURING THE FIRST TREATMENT, THE CROWN COULD NOT CROSS A 90

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 22105492 ↗
• InjuryApr 17, 2025Entrapment of Device; Material Separation; Difficult to Advance; Unexpected Shutdown; Device Contaminated at the User Facility; Entrapment of Device; Material Separation; Difficult to Advance; Unexpected Shutdown; Device Contaminated at the User Facility

  IT WAS REPORTED THAT THE PHYSICIAN ACCESSED THE OCCLUDED ANTERIOR TIBIAL (AT) ARTERY WITH A GLIDEWIRE ADVANTAGE .014 GUIDEWIRE. IT WAS A 100% CALCIFIED OCCLUSION, 2.5-3.0 SIZED VESSEL PROXIMAL TO MID AND 1.5-2.0 DISTALLY. THE GLIDEWIRE WAS EXCHANGED FOR A VIPERWIRE GUIDEWIRE. THE VESSEL WAS TREATED WITH A 1.25 MICRO DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). THE PROXIMAL PORTION OF THE VESSEL WAS TREATED BY ATHERECTOMY ON ALL THREE SPEEDS WITHOUT ANY ISSUE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE OAD BUT MET RESISTANCE. HOWEVER, THE OAD ADVANCED WITH GLIDEASSIST AND WAS ABLE TO TREAT THE MID PORTION OF THE VESSEL ON ALL THREE SPEEDS WITHOUT ISSUE. THE OAD WAS ADVANCED USING GLIDEASSIST TO TREAT THE DISTAL PORTION OF THE VESSEL. THE OAD BOGGED DOWN AND STOPPED ON LOW SPEED IN THE ANKLE. THE PHYSICIAN ATTEMPTED TO POWER THE DEVICE ON AND CONTINUE TREATMENT BUT THE OAD CONTINUED TO SHUT OFF. THE OAD WAS USED WITH GLIDEASSIST, BUT IT CONTINUED TO SHUT OFF WHEN THE BLACK POWER BUTTON WAS PUSHED. AN ATTEMPT WAS MADE TO PULL THE GUIDEWIRE AND OAD OUT TOGETHER BUT WAS UNSUCCESSFUL. AS PER THE PHYSICIAN, THE ISSUE WAS CAUSED BY SEVERE, ECCENTRIC CALCIUM. ON FLUOROSCOPY, IT DID

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21858302 ↗
• InjuryJan 9, 2025Entrapment of Device; Device Contaminated at the User Facility; Entrapment of Device; Device Contaminated at the User Facility

  IT WAS REPORTED THAT THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR TIBIAL ARTERY (ATA). ATTEMPTS TO SNARE THE OAD WERE UNSUCCESSFUL AND THEREFORE, THE PATIENT UNDERWENT POPLITEAL BYPASS SURGERY DURING WHICH THE CROWN OF THE OAD WAS REMOVED. THE IMAGES RECEIVED SHOWED THAT THE OAD WAS CONTAMINATED. THE PATIENT WAS HOSPITALIZED POST FEMORAL-POPLITEAL ARTERY BYPASS GRAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21116155 ↗
• InjuryOct 23, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT DURING TREATMENT OF 99-100% STENOSED LESION IN POSTERIOR TIBIAL ARTERY (PT) VIA PEDAL ANTERIOR TIBIAL ARTERY (AT) ACCESS, THE CROWN OF THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DETACHED FROM THE DRIVESHAFT. UP AND OVER INTO THE POSTERIOR TIBIAL ARTERY (PT) WAS WHERE THE CROWN APPEARED TO HAVE FRACTURED. THE FRACTURED CROWN WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517360 ↗
• InjuryNov 2, 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 FOR AN ATHERECTOMY PROCEDURE. A PERFORATION WAS OBSERVED.

  Patient problems: Perforation of Vessels; Vascular Dissection

  MAUDE report 18058259 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT OF THE POSTERIOR TIBIAL ARTERY, THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) MICRO CROWN PERFORATED THE VESSEL. THE OAD WAS REMOVED AND A BALLOON WAS ADVANCED ACROSS THE PERFORATION AND INFLATED FOR TWO MINUTES TO OCCLUDE FLOW. AFTER THE BALLOON WAS DEFLATED, THE PERFORATION WAS NO LONGER VISIBLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 15282696 ↗
• InjuryMay 12, 2022Entrapment of Device; Entrapment of Device

  THE CROWN OF THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME ENTRAPPED IN A CALCIFIED AREA OF THE PATIENT'S PERONEAL ARTERY, AND THE OAD STALLED. THE VESSEL WAS PROFUSELY DISEASED, APPROXIMATELY 2.5 MM IN DIAMETER, AND WAS 80% TO 90% STENOSED. THE PHYSICIAN REMOVED THE VIPERWIRE ADVANCE GUIDE WIRE AND DETACHED THE SALINE LINE FROM THE DEVICE. THE SALINE SHEATH OF THE DRIVESHAFT WAS REMOVED. THE CROWN REMAINED IN VIVO. SURGERY WAS PERFORMED TO ACCESS THE PERONEAL ARTERY. THE STUCK SEGMENT OF THE OAD WAS REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14377985 ↗
• InjuryApr 1, 2022Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA LEFT GROIN ACCESS AND ANTEGRADE APPROACH FOR TREATMENT OF A HEAVILY CALCIFIED, HIGHLY STENOSED LESION PROXIMALLY IN THE ANTERIOR TIBIAL ARTERY (AT). THERE WAS ONE RUN OFF VESSEL. THE VESSEL HAD SHUT DOWN FOLLOWING PRIOR ANGIOPLASTY. FOUR TREATMENTS WERE PERFORMED ON LOW SPEED, AND THREE TREATMENTS WERE PERFORMED ON MEDIUM SPEED USING THE DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE (OAD). THE GLIDEASSIST FUNCTION WAS USED TO ADVANCE TO A DISTAL LESION. DIFFICULTY WAS EXPERIENCED MAINTAINING WIRE POSITION WHILE GLIDEASSIST WAS ACTIVE, AND GLIDEASSIST WAS DISCONTINUED. THE OAD ADVANCED TO THE MID ANTERIOR TIBIAL ARTERY, BUT NO FARTHER. THE OAD WAS PULLED BACK FOR REMOVAL BUT BECAME STUCK AT THE PROXIMAL LESION. MULTIPLE TROUBLESHOOTING ATTEMPTS WERE MADE TO REMOVE THE DEVICE. THE DRIVESHAFT AND SALINE LINE WERE THEN CUT AT THE STRAIN RELIEF, AND THE SALINE SHEATH WAS REMOVED. A 6 FR GUIDE CATHETER WAS OPENED, PLACED OVER THE OAD DRIVE SHAFT, AND ADVANCED TO FREE THE CROWN. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13978281 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATHERECTOMY WAS PERFORMED WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE PERONEAL ARTERY VIA CONTRALATERAL APPROACH. TREATMENT WAS FOLLOWED BY IMAGING, WHICH REVEALED A DISSECTION AT THE BIFURCATION. BALLOON ANGIOPLASTY WAS APPLIED FOR 15 MINUTES TO RESOLVE THE DISSECTION. THE PATIENT WAS IN GOOD CONDITION AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 13827927 ↗
• InjuryAug 24, 2021Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON LOW SPEED THROUGH THE PEDAL LOOP, WHICH WAS 2.0MM AND 95% STENOSED WITH MILD TO MODERATE CALCIUM THROUGHOUT. THE OAD BECAME STUCK IN THE ARCH OF THE FOOT, AND AN ATTEMPT TO SPIN THE DEVICE BACKWARDS WAS UNSUCCESSFUL. NITROGLYCERIN WAS ADMINISTERED TO REDUCE SPASM AROUND THE CROWN AND GUIDE CATHETERS WERE ADVANCED, BUT THE DEVICE COULD NOT BE REMOVED. A BALLOON WAS INFLATED BESIDE THE CROWN IN AN ATTEMPT TO RELEASE IT BUT WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AND A CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE OAD. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. PER THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE ISSUE WAS VESSEL SPASM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Device Embedded In Tissue or Plaque

  MAUDE report 12359888 ↗
• InjuryJun 24, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK GEN2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A PEDAL ARTERY, WHICH WAS MODERATELY CALCIFIED AND HAD A VESSEL DIAMETER OF 1.5-2.0MM. DURING TREATMENT THE OAD CROWN BECAME STUCK IN THE PEDAL LOOP. ATTEMPTS TO REMOVE THE DEVICE INCLUDING GLIDEASSIST MODE AND INSERTION OF A CATHETER WERE MADE, BUT WERE UNSUCCESSFUL, AND EVENTUALLY A BUDDY WIRE WAS INSERTED TO FREE THE DEVICE FROM THE VESSEL. A DELAY OF 30 MINUTES OR GREATER OCCURRED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12062986 ↗
• InjuryJun 9, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED FOR SEVERAL TREATMENT PASSES IN THE POSTERIOR TIBIAL (PT) ARTERY, AND DURING THE REMOVAL PROCESS THE OAD COULD NOT BE REMOVED FROM THE PATIENT'S BODY. GLIDEASSIST WAS ACTIVATED, AND THE OAD MOMENTARILY SPUN BEFORE IT STOPPED SPINNING. NITROGLYCERIN WAS ADMINISTERED, HOWEVER THE OAD REMAINED STUCK IN THE VESSEL. THE OAD AND WIRE WERE REMOVED AND WIRE ACCESS WAS LOST. A TYPE F DISSECTION WAS OBSERVED IN THE LATERAL PLANTAR ARTERY AND BALLOON ANGIOPLASTY WAS USED TO RESOLVE THE DISSECTION.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 11966755 ↗
• InjuryJun 8, 2021Unintended System Motion; Unintended System Motion

  TREATMENT WAS PERFORMED VIA LEFT FEMORAL ACCESS WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE POPLITEAL AND PROXIMAL ANTERIOR TIBIAL ARTERY (AT), EACH OF WHICH WAS 80% STENOSED. THE VESSEL DIAMETER WAS 3MM, AND THE LESIONS WERE MODERATELY CALCIFIED. THE PROXIMAL AT LESION WAS TREATED ON LOW, MEDIUM, AND HIGH SPEED FOR 15 SECONDS EACH. DURING THE FINAL TREATMENT, THE USER FELT THE DEVICE JUMP BACKWARDS, AND THE DEVICE BECAME STUCK ON THE GUIDE WIRE. THE USE OF GLIDEASSIST DID NOT RESOLVE THE ISSUE. THE OAD AND WIRE WERE REMOVED FROM THE PATIENT, AND THE VESSEL WAS REWIRED. ANGIOGRAPHY SHOWED NO FLOW IN THE VESSEL AND A DISSECTION IN THE PROXIMAL AT. ANGIOPLASTY WAS PERFORMED. THEREAFTER, A PERFORATION WAS OBSERVED. THE BALLOON WAS REINSERTED AND INFLATED FOR FIVE MINUTES. THE PROCEDURE WAS DELAYED BY 30 MINUTES OR MORE DUE TO TIME TAKEN TO REWIRE THE VESSEL. THE PATIENT WAS STABLE WITH NO COMPLAINT OF PAIN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Perforation; Vascular Dissection

  MAUDE report 11962244 ↗
• InjuryApr 26, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN A BEND IN THE SEVERELY CALCIFIED AND TORTUOUS 1.5-2 MM PEDAL LOOP. GLIDEASSIST WAS ACTIVATED IN AN ATTEMPT TO REMOVE THE DEVICE, FOLLOWED BY PULLING ON THE DEVICE WHILE IT WAS SPINNING. THE OAD WAS UNABLE TO BE REMOVED. THE SHEATH OF THE OAD WAS CUT IN AN ATTEMPT TO ADVANCE IT OVER THE CROWN, HOWEVER THIS WAS NOT SUCCESSFUL. THE PATIENT WAS TRANSFERRED TO SURGERY AND A BELOW THE KNEE AMPUTATION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11724723 ↗
• InjuryMar 25, 2021Entrapment of Device; Mechanical Problem; Entrapment of Device; Mechanical Problem

  A PROCEDURE WAS PLANNED FOR A SUBTOTAL OCCLUSION IN THE ANTERIOR TIBIAL ARTERY. AN ATTEMPT WAS MADE TO CROSS THE LESION WITH A RE-ENTRY DEVICE, BUT THE ATTEMPT WAS UNSUCCESSFUL EVEN AFTER THE DEVICE WAS TORQUED, WHICH LIKELY CAUSED SOME VESSEL DAMAGE. TWO GUIDE WIRES WERE ABUTTED FROM FOOT AND GROIN ACCESS SITES. A CATHETER WAS USED TO EXCHANGE FOR A VIPERWIRE GUIDE WIRE. THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ACTIVATED, BUT IT STALLED SEVERAL TIMES AND BECAME STUCK IN THE VESSEL. THE OPINION OF THE PHYSICIAN WAS THAT THE DEVICE WAS LIKELY SUBINTIMAL. THE PHYSICIAN PULLED WITH FORCE ON THE OAD, AND ENDOTHELIUM WAS OBSERVED ON THE OAD. NO FLOW WAS OBSERVED, AND UNPLANNED STENTS WERE PLACED IN THE VESSEL. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS FINE AND FLOW IN THE VESSEL HAD BEEN RESTORED.

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

  MAUDE report 11569903 ↗
• InjuryFeb 25, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN A LESION IN THE SUPERFICIAL FEMORAL ARTERY. RADIAL ACCESS WAS OBTAINED AND A BALLOON WAS USED TO PUSH THE CROWN, WHICH EVENTUALLY CAME FREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11379187 ↗
• MalfunctionJan 11, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO ENGAGE A 90% STENOSED, SEVERELY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY. THE CROWN OF THE OAD BECAME STUCK IN THE LESION TWICE, AND ON THE THIRD TREATMENT ATTEMPT THE DRIVESHAFT FRACTURED AT THE PROXIMAL SIDE OF THE CROWN. THE OAD FRAGMENT REMAINED ON THE GUIDE WIRE AND WAS ABLE TO BE REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. ANOTHER OAD WAS USED TO COMPLETE THE PROCEDURE WITH A GOOD RESULT.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 11148004 ↗
• InjuryNov 24, 2020Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF THE ANTERIOR TIBIAL (AT) ARTERY. THE PROXIMAL AT WAS 99% STENOSED, AND THE MID AT WAS APPROXIMATELY 70% STENOSED. DURING TREATMENT, THE CROWN BECAME STUCK IN THE DISTAL LESION. IT WAS NOT CLEAR WHY OR HOW THE DEVICE BECAME STUCK, HOWEVER, CONSIDERATIONS INCLUDED A POSSIBLE FLAP PRESENT OR THAT THE DISEASE WAS UNDERESTIMATED. AFTER MULTIPLE TECHNIQUES WERE USED TO DISLODGE THE CROWN, THE CROWN WAS FREED, AND WIRE POSITION WAS LOST. IMAGING SHOWED A TYPE C DISSECTION HAD OCCURRED. IT WAS DETERMINED THAT THE DISSECTION WAS CAUSED VIA THE DEVICE BECOMING STUCK IN THE LESION. THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY FOR A GOOD FINAL RESULT OF THE PROCEDURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 10891484 ↗
• InjuryOct 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF LESIONS IN THE POSTERIOR TIBIAL ARTERY. TREATMENTS WERE PERFORMED ON MEDIUM AND HIGH SPEEDS IN THE PROXIMAL VESSEL AND LOW AND MEDIUM IN THE MID AND DISTAL VESSEL. AFTER SPINNING, NO FLOW WAS OBSERVED IN THE DISTAL VESSEL. IT WAS DETERMINED THAT THE NO FLOW WAS CAUSED BY EMBOLI AND THAT ORBITAL ATHERECTOMY CONTRIBUTED TO THE EMBOLIZATION. THE TYPE OF EMBOLI WAS UNDETERMINED. THE VESSEL WAS TREATED WITH BALLOON ANGIOPLASTY, HOWEVER, FLOW WAS UNABLE TO BE RESTORED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. AS OF (B)(6) 2020, NO ADDITIONAL INTERVENTION HAD BEEN PERFORMED TO RESTORE FLOW.

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

  MAUDE report 10754534 ↗
• MalfunctionOct 26, 2020Entrapment of Device; Entrapment of Device

  THE ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK ON THE VIPERWIRE DURING USE IN THE ANTERIOR TIBIAL ARTERY VIA FEMORAL ACCESS. THE OAD WAS ADVANCED AGAIN, AND GLIDEASSIST WAS ACTIVATED IN AN ATTEMPT TO FREE THE OAD FROM THE WIRE. THIS WAS NOT EFFECTIVE, AND THE OAD AND WIRE WERE REMOVED FROM THE PATIENT TOGETHER AFTER A DELAY OF 30 MINUTES OR MORE DUE TO THE TIME IT TOOK TO REWIRE THE VESSEL. THERE WERE NO COMPLICATIONS TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANGIOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10732683 ↗
• InjuryAug 24, 2020Entrapment of Device; Entrapment of Device

  DURING USE OF A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE ANTERIOR TIBIAL ARTERY, THE DEVICE INTERACTED WITH TISSUE WILL SPINNING AND BECAME STUCK TO THE VESSEL WALL. THE OAD WAS TURNED OFF AND ON MULTIPLE TIMES TO RELEASE THE CROWN, AND WAS REMOVED FROM THE PATIENT. TISSUE WAS NOTED AROUND THE DEVICE CROWN AND PER THE OPINION OF THE PHYSICIAN, A NON-VISIBLE DISSECTION MAY HAVE BEEN PRESENT PRIOR TO THE PROCEDURE WHICH RESULTED IN THE ISSUE. A TYPE B DISSECTION WAS PRESENT FOLLOWING REMOVAL OF THE OAD AND WAS RESOLVED WITH A LONG BALLOON INFLATION. THE VESSEL WAS THEN RE-WIRED AND ANOTHER OAD WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection; Vessel Or Plaque, Device Embedded In

  MAUDE report 10442045 ↗