Stealth PRD-SC30-125 (REF 7-10059-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10850000491271), received between Jul 1, 2020 and Sep 18, 2026 — classified as 21 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (12 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50825007 ↗
• InjuryJul 30, 2026Entrapment of Device

  It was reported that the procedure was to treat mildly calcified, mildly tortuous lesion in anterior tibial artery (AT) through common femoral artery access. The vessel diameter was unknown as no intravascular ultrasound (IVUS) was used. During treatment, the crown of the 1.25 solid Stealth 360 Peripheral Orbital Atherectomy Device (OAD) became stuck at the midpoint of the artery. Additional nitroglycerin beyond standard of care was administered, the OAD was turned off/on several times, and the OAD was removed from the patient. The OAD was intact and had no tissue/plaque. The procedure was completed without using other devices. There was no clinically significant delay in procedure and no adverse patient effects.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090293 ↗
• InjuryMar 12, 2026Unexpected Shutdown

  IT WAS REPORTED THAT DURING PROCEDURE, STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT CALCIFIED PROXIMAL ANTERIOR TIBIAL ARTERY FROM PEDAL ACCESS. AFTER TWO TO THREE TREATMENTS, THE OAD WAS HEARD BOGGING DOWN. THE OAD WAS REMOVED AND A SMALL PERFORATION WAS OBSERVED. A BALLOON WAS INFLATED TO TAMPONADE THE PERFORATION. PERFORATION WAS RESOLVED AFTER THE BALLOON WAS INFLATED FOR TWO MINUTES. THE PATIENT WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 24582294 ↗
• InjuryOct 3, 2025Off-Label Use; Difficult to Remove; Device-Device Incompatibility; Unexpected Shutdown; Off-Label Use; Difficult to Remove; Device-Device Incompatibility; Unexpected Shutdown

  IT WAS REPORTED THAT THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED WITH THE ABBOTT COMMAND GUIDE WIRE. THE 60-70% STENOSED POPLITEAL ARTERY POST INTRAVASCULAR ULTRASOUND (IVUS) WAS TREATED SUCCESSFULLY. THE OAD WAS THEN ADVANCED DISTALLY TO THE CALCIFIED, 70-80% STENOSED POSTERIOR TIBIAL (PT) ARTERY. THE OAD STALLED IN THE DISTAL PT. THE COMMAND WIRE BECAME STUCK ON THE OAD AND HAD TO BE REMOVED TOGETHER CAUSING LOSS OF WIRE ACCESS. A SMALL PERFORATION WAS OBSERVED IN THE DISTAL PT WHERE THE OAD CROWN STALLED. PLANNED PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO RESOLVE THE PERFORATION. THE PATIENT WAS STABLE. WHILE EX VIVO, THE PHYSICIAN WAS ABLE TO REMOVE THE COMMAND WIRE OUT OF THE OAD. THE PHYSICIAN UNDERSTOOD USING THE COMMAND WIRE WITH THE OAD IS OFF LABEL AND THE INSTRUCTIONS FOR USE (IFU) WAS NOT DIFFICULT TO READ/UNDERSTAND. THE PHYSICIAN WAS ALLEGING MALFUNCTION OF THE OAD.

  Patient problems: Perforation of Vessels

  MAUDE report 23211158 ↗
• MalfunctionJun 16, 2025Material Separation; Unexpected Shutdown; Material Separation; Unexpected Shutdown

  IT WAS REPORTED THAT THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED UP AND OVER FROM THE LEFT FEMORAL ARTERY FOR TREATMENT OF MODERATELY CALCIFIED, MILDLY TORTUOUS, 90-95% STENOSED LESION IN THE RIGHT DISTAL POPLITEAL ARTERY AND RIGHT ANTERIOR TIBIAL ARTERY (AT). THERE WAS SOME TORTUOSITY THROUGH THE POPLITEAL THEN A SHARP ANGLE INTO THE AT. WHILE TREATING INTO THE AT PROXIMAL TO DISTAL, THE OAD CROWN STOPPED MOVING WITH THE THROW. THE THROW WAS MOVED AGAIN, BUT THE OAD CROWN STILL WAS NOT MOVING AS THE MOTOR WAS RUNNING BUT THE OAD CROWN COULD NOT BE ADVANCED. THE OAD HAD STALLED. THE PHYSICIAN ATTEMPTED TO MOVE THE THROW AGAIN TO GET THE OAD CROWN TO MOVE BUT WAS UNSUCCESSFUL. AT THIS POINT, IT WAS REALIZED THE OAD DRIVESHAFT WAS FRACTURED AND THE DISTAL CROWN AND DISTAL PART OF THE OAD DRIVESHAFT REMAINED IN-VIVO WHEN THE OAD WAS RETRACTED. THE FRACTURED COMPONENT REMAINED ON THE VIPERWIRE ADVANCE GUIDE WIRE. THE PHYSICIAN WAS ABLE TO FLOSS THE GUIDE WIRE WITH THE FRACTURED COMPONENT THROUGH THE DISTAL SHEATH TO REMOVE IT FROM THE PATIENT. NO ADDITIONAL INTERVENTION WAS REQUIRED TO REMOVE THE FRACTURED COMPONENT. THERE WERE NO PATIENT COMPLICATIONS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213298 ↗
• InjuryJan 9, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN A TIGHT AREA OF HEAVILY CALCIFIED AND HEAVILY TORTUOUS PROXIMAL SEGMENT OF THE ANTERIOR TIBIAL (AT) ARTERY, WHEN THE OAD SHUT OFF DURING SECOND TREATMENT. THE LIGHTS ON THE OAD WERE STILL ON WHEN IT STOPPED SPINNING. IT WAS INITIALLY SUSPECTED THAT THE OAD WAS STUCK BUT IT WAS ABLE TO BE REMOVED WITHOUT ANY ISSUES. IT WAS NOTED THE SALINE PUMP DID NOT POWER OFF WHEN THE ISSUE OCCURRED. ANGIOGRAPHY WAS PERFORMED AND PSEUDOANEURYSM WAS OBSERVED. A COVERED STENT WAS PLACED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Pseudoaneurysm

  MAUDE report 21116459 ↗
• MalfunctionJan 9, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A MODERATELY CALCIFIED PROXIMAL SEGMENT IN THE LEFT ANTERIOR TIBIAL (AT) ARTERY. THE FLOW OF SALINE APPEARED TO BE SUFFICIENTLY FLOWING DURING DEVICE PREPARATION, HOWEVER, WHEN IT WAS REMOVED FROM THE BODY AND FLUSHED, IT APPEARED THAT THE SALINE DID NOT COME OUT OF THE TIP OF THE OAD. DURING THE PROCEDURE, IT APPEARED THE SALINE COULD NOT REACH THE HANDLE OF THE OAD, THUS THE OAD WAS REMOVED FROM THE PATIENT. IT WAS OBSERVED BLOOD HAD BACKED UP INTO THE OAD. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21115906 ↗
• InjuryNov 14, 2024Break; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Mechanical Jam; Noise, Audible; Break; Entrapment of Device; Difficult to Remove; Improper or Incorrect Procedure or Method; Failure to Advance; Mechanical Jam; Noise, Audible

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN PROXIMAL-TO-DISTAL POPLITEAL ARTERY INTO THE ANTERIOR TIBIAL ARTERY (AT) VIA FEMORAL ACCESS. THE OAD CROWN WAS ADVANCED INTO MID POPLITEAL BUT COULD NOT BE ADVANCED. WIRE PLACEMENT WAS CONFIRMED FINE. THE CROWN ADVANCER KNOB WAS USED TO ADVANCE THE CROWN BUT FAILED. WHEN THE CROWN WAS ATTEMPTED TO BE SPUN A HIGH-PITCHED NOISE WAS HEARD. THE CROWN WAS DETERMINED TO BE STUCK/WRAPPED IN TISSUE. THE CROWN AND ADVANCER KNOB COULD NOT BE BROUGHT BACK INTO THE DISTAL LOCK POSITION DESPITE LOOSENING THE CONTROL KNOB. AFTER A FEW ATTEMPTS TO ADVANCE AND PULL BACK THE OAD, THE CROWN WAS FREED UP FROM THE TISSUE. THE SHEATH AND CROWN WERE ABLE TO BE PULLED BACK INTO POSITION BUT COULD NOT BE PULLED THROUGH THE 6 X 45CM GUIDING SHEATH. AFTER MULTIPLE FAILED ATTEMPTS TO PULL THE SHEATH AND CROWN THROUGH THE GUIDING SHEATH THE PATIENT WAS TRANSFERRED TO THE HOSPITAL FOR SURGICAL REMOVAL OF DEVICE TO PREVENT DAMAGE TO THE VESSEL. EX VIVO, THE OAD SHEATH WAS FOUND DAMAGED DUE TO THE PHYSICIAN PULLING ON IT TO TRY AND GET IT THROUGH THE GUIDING SHEATH IN VIVO. ADDITIONAL INFORMATION WAS RECEIVED FROM THE A

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20684929 ↗
• InjuryOct 3, 2023Entrapment of Device; Entrapment of Device

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK DURING TREATMENT OF A CALCIFIED LESION IN THE ANTERIOR TIBIAL (AT) ARTERY. THE PHYSICIAN BELIEVED THEY WERE IN THE LESION; HOWEVER, THEY WERE IN A LARGE COLLATERAL DUE TO PATIENT ANATOMY. DUE TO THIS, THE VESSEL SPASMED. THE PATIENT WAS BROUGHT TO SURGERY FOR REMOVAL OF THE OAD. THE SURGERY WAS SUCCESSFUL. THE PATIENT WAS STABLE.

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

  MAUDE report 17864990 ↗
• InjuryAug 25, 2023Entrapment of Device; Entrapment of Device

  DURING A LOW SPEED TREATMENT, THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE 95% STENOSED POSTERIOR TIBIAL ARTERY. THE CROWN DID NOT MOVE WITH THE GUIDE WIRE. THE OAD CROWN SPEED BEGAN TO SLOW DOWN AND TURNED OFF. A GLIDE WIRE WAS PLACED NEXT TO THE OAD AND LOOSENED THE CROWN. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17624075 ↗
• MalfunctionJul 26, 2023Material Puncture/Hole; Device Contamination with Body Fluid; Material Puncture/Hole; Device Contamination with Body Fluid

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE PATIENT. AFTER TREATMENT, THE OAD WAS REMOVED AND BLOOD WAS LEAKING OUT. THE OAD WAS REMOVED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17400392 ↗
• InjuryMay 17, 2023Off-Label Use; Material Separation; Off-Label Use; Material Separation

  DURING DEVICE PREPARATION, ADVISEMENT WAS GIVEN TO THE PHYSICIAN TO USE A VIPERWIRE ADVANCE GUIDE WIRE IN ACCORDANCE WITH THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) INSTRUCTIONS FOR USE. THE OAD WAS ADVANCED OVER A NON-CSI GUIDE WIRE AND ADVANCED TO THE ANTERIOR TIBIAL ARTERY (AT). A TREATMENT WAS PERFORMED ON LOW SPEED AND MEDIUM SPEED IN THE PROXIMAL AT. THE CROWN WAS ADVANCED DISTALLY AND A TREATMENT WAS PERFORMED ON LOW SPEED. THE CROWN WAS OBSERVED TO BE DETACHED FROM THE DRIVESHAFT. THE OAD WAS REMOVED. THE CROWN WAS OBSERVED NEAR THE TREATED LESION. AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED CROWN WITH A BALLOON, HOWEVER, THE BALLOON RUPTURED UPON INFLATION. A SECOND BALLOON WAS USED TO REMOVE THE CROWN. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16950487 ↗
• InjuryJul 8, 2022Entrapment of Device; Entrapment of Device

  ATHERECTOMY WAS BEING PERFORMED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POSTERIOR TIBIAL (PT) ARTERY IN AN ANTEGRADE MOVEMENT BEGINNING IN THE SFA. WHEN THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED TO THE SEGMENT OF THE PT NEAR THE MEDIAL MALLEOLUS THE CROWN BECAME STUCK. THE OAD STALLED. INTRAARTERIAL NITROGLYCERINE WAS ADMINISTERED AND AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE OAD. A BLOOD PRESSURE CUFF WITH OCCLUSIVE PRESSURE WAS PLACED AROUND THE CALF FOR APPROXIMATELY FIVE MINUTES. WHEN THE BLOOD PRESSURE CUFF WAS REMOVED, AND WITH SIGNIFICANT FORCE, THE OAD AND GUIDE WIRE WERE PULLED OUT TOGETHER AS THE GUIDE WIRE HAD BECOME KINKED. BALLOON ANGIOPLASTY WAS THEN PERFORMED TO COMPLETE THE PROCEDURE. FOLLOWING THE PROCEDURE, THE PATIENT WAS IN SATISFACTORY CONDITION. IN THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A VESSEL SPASM.

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

  MAUDE report 14952709 ↗
• InjuryMar 17, 2022Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA FEMORAL ACCESS AND CONTRALATERAL APPROACH. THE DISTAL TARGET VESSEL WAS APPROXIMATELY 2-2.5MM IN DIAMETER, AND THE LESION WAS A CHRONIC TOTAL OCCLUSION. THE LESION WAS HEAVILY CALCIFIED WITH NO TORTUOSITY. THE FIRST LOW-SPEED TREATMENT WAS SUCCESSFUL. A MEDIUM-SPEED TREATMENT WAS INITIATED, AND AN UNEXPECTED AUDIBLE NOISE WAS OBSERVED. THE OAD COULD NOT BE REMOVED PAST THE PROXIMAL PORTION OF THE ANTERIOR TIBIAL ARTERY AND WAS APPARENTLY TRAPPED IN A DISSECTION PLANE. AFTER MULTIPLE ATTEMPTS AT PULLING THE OAD, THE ATTEMPT WAS ABANDONED. THE PHYSICIAN ATTEMPTED TO OBTAIN PEDAL ACCESS TO TRY TO SNARE OR BREAK THE OAD FREE. PEDAL ACCESS WAS NOT AN OPTION DUE TO VESSEL CHARACTERISTICS. AS A LAST EFFORT, THE DRIVESHAFT AND SALINE SHEATH WERE CUT SO THAT THE PHYSICIAN COULD USE A 100CM GUIDE CATHETER OVER THE SALINE SHEATH TO TRY TO CAPTURE THE CROWN. THE ATTEMPT WAS NOT SUCCESSFUL. THE PHYSICIAN THEN UNSUCCESSFULLY ATTEMPTED TO WIRE THE AT AND PASS A SMALL BALLOON TO TRY AND FREE THE CROWN. THE DECISION WAS MADE TO MAKE ARRANGEMENTS WITH A SURGEON AND A TRANSPORT TEAM IN ORDER TO MOVE THE PATIENT SAFELY TO THE OR WITH T

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 13801804 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED FOR MULTIPLE TREATMENT PASSES IN THE DISTAL AND PROXIMAL ANTERIOR TIBIAL ARTERY (AT). WHEN THE OAD WAS REMOVED, IT WAS NOTED TO BE STUCK ON THE GUIDE WIRE. THE OAD AND WIRE WERE REMOVED FROM THE PATIENT AND THE LESION WAS RE-WIRED AND BALLOON ANGIOPLASTY WAS PERFORMED. SLOW FLOW WAS THEN NOTED IN THE AT AND WAS RESOLVED WITH BALLOON ANGIOPLASTY AND NITROGLYCERIN. THE PATIENT WAS WELL AT THE CONCLUSION OF THE PROCEDURE. THE PHYSICIAN DID NOT PROVIDE AN OPINION AS TO THE CAUSE OF THE SLOW FLOW.

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

  MAUDE report 12688982 ↗
• MalfunctionAug 20, 2021Infusion or Flow Problem; Infusion or Flow Problem

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A 100% STENOSED, SEVERELY CALCIFIED LESION IN THE TIBIOPERONEAL TRUNK (TPT) AND PERONEAL ARTERY. FOUR TREATMENTS ON LOW SPEED WERE PERFORMED IN THE TPT AND HIGH SPEED TREATMENTS WERE STARTED IN THE PERONEAL ARTERY. THE OAD BECAME STUCK ON THE GUIDE WIRE, AND THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER. A PIN HOLE WAS NOTED IN THE SALINE SHEATH, AND A MAJORITY OF THE VIPERSLIDE WAS SPRAYING OUT. NO PATIENT COMPLICATION WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12348389 ↗
• InjuryJul 21, 2021Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A CHRONIC TOTAL OCCLUSION LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA FEMORAL ACCESS. TWO TREATMENTS WERE ADMINISTERED ON LOW SPEED. THE OAD BECAME STUCK ON THE GUIDE WIRE DURING REMOVAL. THE WIRE AND OAD WERE REMOVED TOGETHER, AND WIRE ACCESS WAS LOST. THE PROCEDURE WAS DELAYED BY 30 MINUTES DUE TO DIFFICULTY REWIRING THE VESSEL. A FLOW-LIMITING DISSECTION WAS OBSERVED IN THE AREA WHERE THE OAD HAD BECOME STUCK ON THE GUIDE WIRE. AN UNPLANNED STENT WAS DEPLOYED OVER THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 12207017 ↗
• InjuryJul 14, 2021Entrapment of Device; Entrapment of Device

  DURING DEVICE ANALYSIS FOR A NON-REPORTABLE EVENT (DEVICE REPORTEDLY BECAME STUCK IN THE VESSEL AND WAS REMOVED WITH PUSH/PULL TECHNIQUE), VISUAL EXAMINATION REVEALED A STENT WRAPPED AROUND THE OAD CROWN. ADDITIONAL INFORMATION WAS REQUESTED FROM THE SITE. ADDITIONAL INFORMATION PROVIDED TO CSI INDICATED THAT DURING THE REMOVAL OF THE OAD AFTER TREATMENT, THE OAD BECAME CAUGHT ON THE STENT. THE PHYSICIAN TURNED THE OAD ON AND OFF QUICKLY TO REMOVE THE OAD FROM THE STENT AND DID NOT NOTICE ANY CHANGE TO THE STENT INTEGRITY ANGIOGRAPHICALLY AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12167132 ↗
• InjuryJul 13, 2021Material Integrity Problem; Material Integrity Problem

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESIONS IN THE MID SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERIES VIA ANTEGRADE FEMORAL ACCESS. THE SHEATH CONTINUALLY BACKED OUT DURING PRIMARY WIRING. AFTER THE WIRE WAS PLACED, THE OAD WAS POSITIONED IN THE SFA, AND ONE TREATMENT WAS PERFORMED ON LOW SPEED. THE SHEATH AGAIN SHIFTED BACK, AND THE OAD STOPPED SPINNING. THE USER REMOVED THE DEVICE AND SHEATH AND LEFT THE WIRE IN PLACE. THE SHEATH WAS KINKED AND WAS REPLACED TO CONTINUE THE PROCEDURE. IT WAS OBSERVED AT THAT TIME THAT THE CROWN AND NOSE OF THE OAD WERE NO LONGER ON THE DRIVESHAFT. FLUOROSCOPY SHOWED THAT THE CROWN AND NOSE WERE STILL IN THE SFA ON THE GUIDE WIRE. A SNARE WAS USED TO ENSURE THAT BOTH THE VIPERWIRE AND OAD FRAGMENT WERE SAFELY REMOVED. A NEW WIRE AND OAD WERE USED TO COMPLETE THE PROCEDURE AS PLANNED WITH ATHERECTOMY AND ANGIOPLASTY. NO ADVERSE PATIENT CONSEQUENCES WERE NOTED, AND NO FURTHER INTERVENTION WAS NEEDED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE WITH PALPABLE AND DOPPLER PULSES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12159953 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF THE POPLITEAL ARTERY, WHICH WAS CALCIFIED. THE OAD WAS OPERATED ON LOW SPEED FOR THREE TREATMENT PASSES, WITH BREAKS BETWEEN EACH PASS. IMAGING WAS PERFORMED AND REVEALED WHAT MAY HAVE BEEN AN OCCLUSION, AS THE POSTERIOR TIBIAL AND ANTERIOR TIBIAL ARTERIES WERE NOT VISIBLE ON THE ANGIOGRAPHY. BALLOON ANGIOPLASTY WAS PERFORMED TO RESTORE FLOW. A CLOSURE DEVICE WAS USED TO OBTAIN HEMOSTASIS IN THE GROIN ACCESS SITE.

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

  MAUDE report 12085739 ↗
• MalfunctionJun 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING TREATMENT OF A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A HOLE WAS NOTED IN THE SALINE SHEATH, CAUSING VIPERSLIDE TO LEAK OUT AND BLOOD TO BACK UP BETWEEN THE SHEATH AND THE OAD DRIVESHAFT. THE OAD WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075755 ↗
• InjuryMay 17, 2021Entrapment of Device; Entrapment of Device

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESIONS IN THE SUPERFICIAL FEMORAL ARTERY AND ANTERIOR TIBIAL ARTERY (AT). DURING TREATMENT IN THE AT, THE DEVICE STALLED AND BECAME STUCK IN THE VESSEL. UNSUCCESSFUL ATTEMPTS TO REMOVE THE DEVICE INCLUDED ANGIOPLASTY, ALTERNATE ACCESS, AND SNARES. THE DRIVESHAFT OF THE OAD WAS CUT, AND A SHEATH WAS ADVANCED OVER THE DRIVESHAFT, BUT THE DEVICE COULD NOT BE REMOVED. THE PATIENT WAS THEN TAKEN BY AMBULANCE TO A HOSPITAL, AND SURGICAL REMOVAL WAS SUCCESSFULLY PERFORMED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11831871 ↗
• InjuryMay 5, 2021Entrapment of Device; Entrapment of Device

  A PERIPHERAL STEALTH ORBITAL ATHERECTOMY DEVICE AND VIPERWIRE GUIDE WIRE WERE SELECTED FOR TREATMENT OF A LESION IN THE DISTAL POSTERIOR TIBIAL ARTERY. AFTER SIX TREATMENTS, THE OAD WAS STUCK ON THE GUIDE WIRE, AND A DISSECTION WAS OBSERVED. THE DISSECTION WAS TREATED WITH AN UNPLANNED BALLOON ANGIOPLASTY FOR THREE MINUTES. THE PROCEDURE WAS THEN COMPLETED, AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Vascular Dissection

  MAUDE report 11776892 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE TREATMENTS (ONE TREATMENT ON EACH SPEED) WERE ADMINISTERED WITH A STEALTH PLUTO ORBITAL ATHERECTOMY DEVICE (OAD) IN THE PERONEAL ARTERY VIA RIGHT GROIN ACCESS AND CONTRALATERAL APPROACH. THE TREATMENT SPEED SEEMED TO SLOW DURING THE FINAL TREATMENT, AND THE PATIENT REPORTED PAIN. THE OAD WAS TURNED OFF, AND TISSUE WAS OBSERVED ON THE CROWN UPON REMOVAL FROM THE PATIENT. ANGIOGRAM SHOWED A PERFORATION IN THE PERONEAL ARTERY. NO DEVICES COULD BE ADVANCED OVER THE WIRE THROUGH THE PERFORATED AREA DESPITE MULTIPLE ATTEMPTS. A BLOOD PRESSURE CUFF WAS PLACED EXTERNALLY TO CONTROL THE PERFORATION. THE PATIENT CONTINUED TO COMPLAIN OF PAIN, BUT THE PATIENT WAS UNSURE WHETHER THE PAIN WAS IN VIVO OR EX VIVO (FROM THE CUFF). PROTAMINE WAS ADMINISTERED TO REVERSE HEPARIN. PAIN MEDICATIONS WERE ALSO ADMINISTERED. THE PATIENT WAS ALERT FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 11327303 ↗
• InjuryDec 10, 2020Entrapment of Device; Entrapment of Device

  AN ATTEMPT WAS MADE TO ADVANCE A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THROUGH A STENT IN ORDER TO TREAT A LESION IN THE MID ANTERIOR TIBIAL ARTERY (AT), HOWEVER THE CROWN WOULD NOT ADVANCE. THE OAD WAS ACTIVATED WITHIN THE STENT AND THE CROWN BECAME STUCK ON A STENT STRUT. PEDAL AT ACCESS WAS OBTAINED AND A BALLOON WAS INSERTED IN AN ATTEMPT TO FREE THE CROWN, BUT IT WAS NOT SUCCESSFUL. THE SHAFT OF THE OAD WAS CUT AND A SNARE WAS ADVANCED OVER THE SHAFT. PRESSURE WAS APPLIED AND THE CROWN WAS REMOVED WITH THE SNARE. THE STENT WAS REMOVED WITH THE OAD, REQUIRING A LARGER SHEATH TO BE INSERTED. FOLLOWING REMOVAL, ANGIOGRAPHY WAS PERFORMED AND THERE WAS NO INDICATION OF VESSEL TRAUMA. A NEW STENT WAS DEPLOYED IN THE PROXIMAL AND MID AT VIA THE PEDAL ACCESS SITE AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10986174 ↗