Stealth PRD-SC30-MICRORecalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10850000491264), received between Oct 24, 2019 and Jun 11, 2026 — classified as 1 death, 39 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (21 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Break

  IT WAS REPORTED THAT DURING PREPARATION THE DRIVESHAFT PROXIMAL TO THE CROWN OF THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS LOOSE AND THE OAD WAS NOT USED. THE ISSUE WAS FOUND AFTER REMOVING THE OAD FROM THE PACKAGE. THE OAD DID NOT ENTER THE ANATOMY. THE OAD WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. DEVICE ANALYSIS IDENTIFIED FOUND THE DISTAL TIP OF THE SALINE SHEATH TO BE SEPARATED BUT STILL ON THE DRIVESHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473991 ↗
• MalfunctionMar 12, 2026Material Separation

  IT WAS REPORTED THAT DURING TREATMENT OF A MODERATELY CALCIFIED UNSPECIFIED ARTERY IN LOWER EXTREMITY WITH A 1.25 MICRO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IT FELT ABNORMAL. THE OAD WAS REMOVED AND THE TIP OF THE SALINE SHEATH WAS OBSERVED FREE FLOATING ON THE OAD DRIVESHAFT. THE OAD WAS REPLACED WITH SAME TYPE AND SIZE OAD TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO INDICATION AS TO WHY THE DETACHMENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582440 ↗
• InjuryOct 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF 99% STENOSED MID ANTERIOR TIBIAL ARTERY (AT). THE VESSEL WAS SMALL AND TORTUOUS. THE OAD BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE IN THE VESSEL. THE PROCEDURE WAS ABORTED AND THE OAD AND VIPERWIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS ABORTED DUE TO PATIENT ANATOMY AND THE OAD UNABLE TO BE SEPARATED FROM VIPERWIRE. THE PATIENT WAS BROUGHT BACK TWO DAYS LATER FOR PLAIN OLD BALLOON ANGIOPLASTY (POBA) ON THE SAME VESSEL WHICH WAS UNSUCCESSFUL. THE PATIENT WAS TRANSFERRED TO A HOSPITAL THAT DAY FOR AMPUTATION WHERE BELOW-THE-KNEE AMPUTATION WAS PERFORMED THE SAME DAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23211033 ↗
• InjuryOct 1, 2025Material Separation; Material Separation

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DRIVESHAFT FRACTURED DURING TREATMENT OF THE ANTERIOR TIBIAL ARTERY (AT). THE FRACTURED COMPONENT WAS RETRIEVED WITH AN UNSPECIFIED BALLOON. IT WAS INDICATED THE FRACTURE LIKELY OCCURRED DURING AN AGGRESSIVE TRANSITION TO THE AT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190244 ↗
• MalfunctionSep 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF CALCIFIED, NON-TORTUOUS, 50-70% STENOSED, 3.0MM LESION IN DISTAL ANTERIOR TIBIAL ARTERY (AT) THROUGH FEMORAL ARTERY ACCESS. THERE WAS A PRE-EXISTING STENT PROXIMAL TO AT THAT WAS NOT TREATED WITH OAD. A LOW-SPEED TREATMENT WAS SUCCESSFULLY PERFORMED. DURING THE SECOND LOW-SPEED TREATMENT THE OAD BECAME STUCK IN THE ARTERY. THE OAD ALSO BECAME STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. THE OAD AND VIPERWIRE WERE REMOVED TOGETHER BY PULLING WITH FORCE. AS THE PHYSICIAN DID NOT WANT TO CONTINUE WITH ANOTHER OAD, THE PROCEDURE WAS DEEMED COMPLETE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PHYSICIAN HAD NO INDICATION AS TO WHAT CAUSED THE OAD TO BECOME STUCK IN THE VESSEL. DEVICE ANALYSIS ON 26AUGUST2025 IDENTIFIED THE DISTAL DRIVESHAFT CROWN WAS ENGAGED IN A STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088316 ↗
• InjuryJul 9, 2025Device Contaminated at the User Facility; Device Contaminated at the User Facility

  DURING REMOVAL OF A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), FOLLOWING TREATMENT OF A HEAVILY CALCIFIED, MILDLY TORTUOUS POPLITEAL ARTERY, BIOLOGICAL TISSUE WAS OBSERVED ON THE CROWN OF THE DEVICE. ANGIOGRAPHIC IMAGING CONFIRMED A NON-FLOW LIMITING DISSECTION. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY FOLLOWED BY STENT PLACEMENT TO TREAT THE DISSECTION AREA. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 22460657 ↗
• InjuryApr 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WERE USED FOR TREATMENT OF LESIONS IN RIGHT ANTERIOR TIBIAL ARTERY (AT) AND POSTERIOR TIBIAL ARTERY (PT) THROUGH PEDAL ACCESS. THE VIPERWIRE WAS PARKED ALL THE WAY DOWN PT BY THE HEEL. TREATMENT WAS STARTED AT THE AT. FIFTEEN TREATMENTS WERE CONTINUED BY PUSHING AND PULLING BACK UNTIL THE DISTAL END OF THE PT WAS REACHED WHERE SOMETHING OPAQUE WAS OBSERVED UNDER FLUOROSCOPY. BALLOONS AND CATHETERS WERE CHECKED TO IDENTIFY THE FRAGMENT BUT WAS UNSUCCESSFUL. THE OAD WAS REMOVED AND FOUND MISSING THE TIP BUSHING. IT WAS DETERMINED THE TIP BUSHING WAS TOO SMALL TO BE SNARED. BALLOON ANGIOPLASTY WAS USED TO PIN THE FRAGMENT TO THE ARTERY WALL. REVIEW OF IMAGES SHOWED THAT DURING TREATMENT OF AT UP AND OVER INTO TIBIOPERONEAL TRUNK (TPT), THE DISTAL END OF THE 1.00MM OAD DRIVESHAFT FRACTURED WHEN THE OAD WAS RETRACTED AFTER GETTING CAUGHT IN SOME PLAQUE. THE CROWN WAS INTACT. NO ONE NOTICED THE TIP BROKE OFF AS IT WAS NOT VISIBLE UNDER FLUOROSCOPY AND WAS MIGRATING DURING SALINE FLUSHING. THE ATHERECTOMY WAS DEEMED FINISHED. THERE WAS A FORTY-FIVE-

  Patient problems: Foreign Body In Patient

  MAUDE report 21788694 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF MODERATELY CALCIFIED, NON-TORTUOUS, 70% STENOSED LESION IN POSTERIOR TIBIAL ARTERY (PT) USING A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THE VESSEL BECAME OCCLUDED DISTAL TO TREATMENT AREA. A 6FR SLENDER SHEATH WAS USED OVER THE WIRE AND VIPERSLIDE LUBRICANT. AN UNSPECIFIED BALLOON WAS USED IN THE (PT) TO REOPEN THE ARTERY AND COMPLETE THE PROCEDURE. NITROGLYCERIN WAS ADMINISTERED. THE PATIENT WAS IN STABLE CONDITION. IN THE OPINION OF THE PHYSICIAN, VESSEL OCCLUSION WAS CAUSED BY CALCIUM SHEDDING AND OCCURRED ONLY BECAUSE THE OAD WAS BEING USED IN THE VESSEL. ADDITIONAL INFORMATION WAS RECEIVED FROM ABBOTT SENIOR ACCOUNT MANAGER ON (B)(6) 2025. THE DATE OF EVENT WILL BE ESTIMATED AS (B)(6) 2025.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21577030 ↗
• InjuryOct 23, 2024Entrapment of Device; Activation Problem; Device Contaminated at the User Facility; Entrapment of Device; Activation Problem; Device Contaminated at the User Facility

  FOLLOWING TREATMENT OF A HEAVILY CALCIFIED, 4MM-DIAMETER LESION IN TIBIAL ARTERY VIA CONTRALATERAL FEMORAL APPROACH, THE 1.25 MICRO STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) CROWN SEEMED TO DECREASE IN SPEED AND BECAME STUCK IN THE VESSEL. THE PHYSICIAN BELIEVED THEY MAY HAVE BEEN SUBINTIMAL THROUGHOUT THE PROCEDURE. THE SYSTEM WAS REMOVED VIA THE VIPERWIRE ADVANCE GUIDE WIRE. UPON REMOVAL OF THE OAD, PATIENT'S VESSEL INTIMA WAS OBSERVED ON THE OAD. NITROGLYCERIN WAS ADMINISTERED TO PREVENT VESSEL SPASM WHICH IS STANDARD PROTOCOL FOR THIS PATIENT. THE PROCEDURE WAS DEEMED COMPLETE. ANGIOGRAPHIC IMAGING LOOKED FINE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20515530 ↗
• InjuryJun 20, 2024Unexpected Shutdown; Unexpected Shutdown

  FEMORAL ACCESS WAS OBTAINED TO TREAT A LESION IN THE DORSALIS PEDIS (DP) ARTERY WITH A DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE (OAD). THE VIPERWIRE ADVANCE GUIDE WIRE WAS NOT ADVANCED THROUGH THE DP. THE PHYSICIAN BELIEVED THERE WAS SUFFICIENT WIRE AT THE DISTAL END. THE OAD WAS ADVANCED THROUGH THE LESION AND TREATMENT WAS STARTED ON LOW SPEED. IN THE MIDDLE OF THE LESION, THE CROWN STOPPED SPINNING. AN ATTEMPT TO RESTART THE OAD WAS MADE, BUT IT CONTINUED TO SPIN FOR SECONDS AND STOP. AN UNSUCCESSFUL ATTEMPT TO ACTIVATE GLIDEASSIST WAS MADE. THE PHYSICIAN REMOVED ALL COMPONENTS. THE ACCESS SITE WAS SEALED, AND THE PROCEDURE ABANDONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575015 ↗
• InjuryJul 13, 2023Entrapment of Device; Entrapment of Device

  A RETROGRADE TREATMENT FROM PEDAL ACCESS WAS PERFORMED IN THE ANTERIOR TIBIAL ARTERY THROUGH THE TIBIOPERONEAL ARTERY AND POSTERIOR TIBIAL ARTERY USING A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). FOLLOWING A HIGH SPEED TREATMENT, THE DEVICE STALLED AND BECAME STUCK IN THE VESSEL. THE OAD SHAFT WAS CUT AND A DIAGNOSTIC CATHETER WAS ADVANCED TO DISLODGE THE CROWN. THE OAD AND GUIDE WIRE WERE REMOVED. THE LESION WAS RE-WIRED SUCCESSFULLY AND BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17314481 ↗
• MalfunctionMay 10, 2023Mechanical Problem; Mechanical Problem

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE TURNED OFF DURING TREATMENT ON HIGH SPEED. THE PUMP WAS UNPLUGGED TO RESOLVE THE ISSUE. THE OAD WAS REMOVED. BALLOON ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904806 ↗
• InjuryApr 7, 2023Use of Device Problem; Use of Device Problem

  DURING TREATMENT IN THE DISTAL ANTERIOR TIBIAL ARTERY (AT) AND DORSALIS PEDIS ARTERY (DP), THE STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) MADE A SLIPPING NOISE. THE OAD WAS IN THE SUBINTIMAL SPACE. THE OAD WAS REMOVED AND TISSUE WAS OBSERVED ON THE SHEATH. ANGIOGRAPHIC IMAGING REVEALED A PERFORATION OF THE DP. BALLOON TAMPONADE WAS PERFORMED TO RESOLVE THE PERFORATION. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 16702076 ↗
• InjuryMar 9, 2023Material Separation; Material Separation

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED THROUGH A 5FR SHEATH IN THE ANTERIOR TIBIAL (AT) ARTERY IN RETROGRADE FASHION, ADVANCED PROXIMALLY TO THE TIBIOPERONEAL TRUNK (TPT) FOLLOWED BY A U-TURN APPROACH BACK THROUGH THE PERONEAL ARTERY (PA). THE OAD WAS ACTIVATED, AND TREATMENT WAS PERFORMED IN THE SEVERELY CALCIFIED PROXIMAL AT, TPT, AND THE PA. THE OAD STOPPED. THE PHYSICIAN DISENGAGED THE ADVANCER KNOB AND RELEASED THE BRAKE. GLIDEASSIST WAS THEN ACTIVATED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE OAD. THE OAD STOPPED AGAIN. THE LEDS WERE NOT ILLUMINATED. AN ATTEMPT TO REACTIVATE THE OAD WAS MADE, HOWEVER THE DEVICE IMMEDIATELY SHUT OFF. THE PHYSICIAN THEN PULLED THE OAD EX VIVO. UPON REMOVAL OF THE DEVICE FROM THE VESSEL, IT WAS NOTICED THAT THE TIP BUSHING HAD BECOME DETACHED. FLUOROSCOPIC IMAGING WAS PERFORMED, AND REVEALED NO EVIDENCE OF THE TIP BUSHING IN VIVO. BALLOON ANGIOPLASTY WAS PERFORMED FOLLOWED BY IMAGING TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16513826 ↗
• InjuryFeb 24, 2023Material Separation; Material Separation

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE 3MM, MODERATELY CALCIFIED, 90% STENOSED ANTERIOR TIBIAL ARTERY (AT). TREATMENT WAS PERFORMED FROM PROXIMAL TO DISTAL. UPON REMOVAL OF THE OAD, THE TIP OF THE DRIVESHAFT WAS OBSERVED TO BE DAMAGED, WITH THE POTENTIAL THAT MATERIAL MAY HAVE WORN OFF THE DEVICE. VISUAL OBSERVATION CONFIRMED DRIVESHAFT DAMAGE. IT IS UNKNOWN IF ANY DRIVESHAFT FRAGMENTS REMAIN IN VIVO. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16440401 ↗
• InjuryDec 3, 2022Material Separation; Material Separation

  VIA TIBIOPEDAL ACCESS, A VIPERWIRE ADVANCE GUIDE WIRE WAS ADVANCED THROUGH A HEAVILY OCCLUDED, CALCIFIED LESION WITH A .014 BUDDY WIRE. THE VIPERWIRE WAS POSITIONED DISTAL TO THE LESION. USING A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE ON LOW SPEED TO CROSS THE LESION. THE TIP BUSHING DID NOT ADVANCE PAST THE LESION, THUS THE CROWN WAS UNABLE TO ENGAGE WITH THE CALCIUM. FLUOROSCOPY REVEALED NO ADVANCEMENT WITH THE OAD. THE OAD STOPPED SPINNING AS IT HAD BEEN OVER TORQUED. THE OAD WAS REMOVED FROM THE PATIENT. FLUOROSCOPY WAS PERFORMED AND REVEALED THE TIP BUSHING HAD FRACTURED AND REMAINED IN VIVO. WHEN REMOVING THE BUDDY WIRE, THE TIP OF THE BUDDY WIRE CAUGHT THE TIP BUSHING FRAGMENT. THE BUDDY WIRE AND TIP BUSHING FRAGMENT WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS STOPPED AS NO DEVICE WAS ABLE TO BE ADVANCED THROUGH THE LESION. FOLLOWING THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. IN THE OPINION OF THE PHYSICIAN, THE TIP BUSHING BECAME LODGED BEHIND CALCIUM AND FRACTURED DURING RETRACTION OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15912397 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR A LOWER EXTREMITY PERIPHERAL ENDOVASCULAR INTERVENTION (PVI). A NON-CSI MICROCATHETER WAS PLACED IN THE TIBIO-PERONEAL TRUNK AND CROSSED A HEAVILY CALCIFIED LESION WITH A VIPERWIRE ADVANCE GUIDE WIRE. THE PHYSICIAN UNSUCCESSFULLY ATTEMPTED TO ADVANCE THE MICROCATHETER DISTALLY DUE TO THE LESION. HOWEVER, THE PHYSICIAN BELIEVED THIS WAS THE VESSEL'S TRUE LUMEN AND BEGAN TREATMENT WITH THE OAD. DURING THE FIRST TREATMENT ON LOW SPEED, THE OAD SUDDENLY STOPPED. THE PHYSICIAN ATTEMPTED TO RETRACT THE CROWN WITH THE CROWN ADVANCER KNOB BUT WAS UNSUCCESSFUL. GLIDEASSIST MODE WAS ACTIVATED MULTIPLE TIMES IN AN ATTEMPT TO FREE THE CROWN, BUT EACH TIME THE OAD STOPPED. IMAGING REVEALED DYE STAINING. THE PHYSICIAN STOPPED THE INTERVENTION, AS THERE WAS A LARGE COLLATERAL VESSEL FILLING THE TIBIO-PERONEAL TRUNK THAT HAD NOT BEEN COMPROMISED. THE PHYSICIAN MANUALLY PULLED THE OAD OUT OF THE TIBIO-PERONEAL TRUNK AND TISSUE WRAPPED AROUND THE OAD CROWN WAS OBSERVED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 15772283 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT IN THE DISTAL ANTERIOR TIBIAL ARTERY AND DORSALIS PEDIS ARTERIES, THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) STALLED WHILE IN THE MID DORSALIS PEDIS ARTERY. THE PATIENT EXPERIENCES RESTLESS LEG SYNDROME AND WHEN INTRAVASCULAR ULTRASOUND WAS EMPLOYED, THE VESSEL SPASMED. WHEN THE OAD WAS REMOVED, A MEDIAL AND INFERIOR PERFORATION OF THE DORSALIS PEDIS ARTERY WAS OBSERVED. ANGIOPLASTY WAS PERFORMED AND LEFT IN PLACE FOR 2 MINUTES TO TAMPONADE THE VESSEL. FINAL ANGIOPLASTY REVEALED A PERFORATION WAS STILL PRESENT. THE PROCEDURE WAS COMPLETED AND, COMPRESSION DRESSING WAS PLACED ON ACCESS SITE ON FOOT.

  Patient problems: Perforation of Vessels

  MAUDE report 14950106 ↗
• MalfunctionApr 27, 2022Material Separation; Material Separation

  A STEALTH 360 GEN 2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE ANTERIOR TIBIAL (AT) ARTERY. ACCESS WAS OBTAINED VIA A CONTRALATERAL FEMORAL APPROACH. THE VESSEL WAS 100% OCCLUDED FROM THE PROXIMAL FEMORAL ARTERY TO THE ANKLE JOINT, APPROXIMATELY 300MM. FLUOROSCOPY REVEALED MODERATE CALCIUM. THE LESION WAS PRIMARY WIRED WITH A NON-CSI WIRE. FOLLOWING WIRE EXCHANGE, THREE ATHERECTOMY PASSES WERE PERFORMED IN THE PROXIMAL SEGMENT ON LOW AND MEDIUM SPEEDS. THE OAD WAS ADVANCED DISTALLY TO THE MID PORTION OF THE AT AND TREATMENT WAS PERFORMED ON LOW SPEED. THE CROWN OF THE OAD BECAME ENTRAPPED IN THE VESSEL. UNSUCCESSFUL ATTEMPTS WERE MADE TO RETRIEVE THE OAD, INCLUDING GLIDEASSIST AND BACKWARD MOVEMENT. THE OAD WAS FORCEFULLY REMOVED, AND THE TIP OF THE OAD DRIVESHAFT FRACTURED IN THE PROXIMAL AT ON THE PROXIMAL END OF THE CROWN. THE FRAGMENT WAS ABANDONED IN VIVO AND NOT STENTED AS THE VESSEL WAS OCCLUDED. ANGIOGRAPHY REVEALED NO OTHER VESSELS WERE COMPROMISED DUE TO THE FRAGMENT. FOLLOWING THE PROCEDURE, THE PATIENT WAS STABLE AND WAS DISCHARGED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14219958 ↗
• InjuryFeb 4, 2022Entrapment of Device; Entrapment of Device

  DURING ORBITAL ATHERECTOMY TREATMENT TO THE PEDAL LOOP IN THE LATERAL PLANTER ARTERY, THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL. THE VESSEL WAS 90% STENOSED AND SEVERELY CALCIFIED. AFTER THREE TO THREE AND A HALF HOURS OF UNSUCCESSFUL ATTEMPTS TO REMOVE THE OAD, INCLUDING MULTIPLE ACCESS SITES, BALLOON TECHNIQUES AND WIRE TECHNIQUES, THE PATIENT WAS TRANSFERRED TO VASCULAR SURGERY TO REMOVE THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13453087 ↗
• InjuryJan 13, 2022Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED IN THE ANTERIOR TIBIAL ARTERY WITHOUT ISSUE. THE OAD WAS THEN ADVANCED TO THE PERONEAL ARTERY AND BECAME STUCK IN THE VESSEL. THE OAD COULD NOT BE REMOVED AND THE PATIENT WAS SENT TO SURGERY. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13252043 ↗
• InjuryNov 23, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SPUN THROUGH THE LESION, AND WHEN RETRACTED BACKWARDS THROUGH THE LESION THE DEVICE POWERED OFF COMPLETELY DUE TO EXCESSIVE TORQUE. THE CROWN WAS STUCK IN THE LESION. GLIDEASSIST AND LOW SPEED WERE ATTEMPTED, HOWEVER THE OAD POWERED OFF AGAIN. A BALLOON WAS PLACED NEXT TO THE CROWN AND INFLATED. ONCE DEFLATED, THE OAD WAS PULLED TO FREE THE CROWN AND LIKELY CAUSED THE DRIVESHAFT TO BECOME STRETCHED, RESULTING IN THE GUIDE WIRE BECOMING STUCK IN THE OAD DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO PATIENT ADVERSE EVENTS AND THE PATIENT WAS DISCHARGED AS PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12866550 ↗
• InjuryNov 22, 2021Material Separation; Material Separation

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) VIA LEFT ANTEGRADE APPROACH. AFTER THE DEVICE WAS ADVANCED INTO THE PROXIMAL SFA, IT BECAME DIFFICULT TO ADVANCE. GLIDEASSIST WAS ENABLED, BUT THE DIFFICULTY PERSISTED. GLIDEASSIST WAS DISABLED, AND LOW SPEED WAS ACTIVATED. THE OAD DID NOT ADVANCE, AND IT WAS TURNED OFF AFTER TWO SECONDS. AT THAT TIME, IT BECAME CLEAR THE CROWN WAS NEAR THE DISTAL END OF THE GUIDE CATHETER. AN ATTEMPT WAS MADE TO PULL THE WIRE AND OAD BACK, AND AT THAT TIME IT WAS DETERMINED THE DRIVESHAFT HAD FRACTURED. THE OAD WAS REMOVED FROM THE PATIENT. A DIAGNOSTIC CATHETER WAS ALTERED AND USED TO SNARE THE FRAGMENT. THE SHEATH AND WIRE WERE THEN REMOVED FROM THE PATIENT. THE DRIVESHAFT FRAGMENT REMAINED INSIDE OF CATHETER UPON REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 12851648 ↗
• InjuryOct 20, 2021Entrapment of Device; Entrapment of Device

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY, AND BALLOON ANGIOPLASTY WAS PERFORMED. DURING REMOVAL OF THE OAD, THE DEVICE BECAME STUCK IN THE DISTAL AT. THE DEVICE WAS EVENTUALLY REMOVED AFTER IT WAS ACTIVATED ON LOW SPEED. BALLOON ANGIOPLASTY WAS PERFORMED, AND TREATMENT TO THE TIBIOPERONEAL TRUNK AND PERONEAL ARTERY WAS PERFORMED WITH A SECOND OAD. A DISSECTION WAS OBSERVED IN THE AT WHERE THE FIRST OAD HAD BECOME STUCK IN THE PROXIMAL AT. IT WAS UNKNOWN WHEN THE DISSECTION OCCURRED, AND A STENT WAS PLACED TO RESOLVE IT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 12667727 ↗
• MalfunctionAug 31, 2021Infusion or Flow Problem; Infusion or Flow Problem

  DURING SET UP, NITROGLYCERIN WAS ADMINISTERED THROUGH THE SALINE LINE AND PART OF THE Y-CONNECTOR OF THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE BROKE OFF. THE ORBITAL ATHERECTOMY DEVICE FILLED WITH BLOOD DUE TO BEING UNABLE TO FLUSH THE DEVICE. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395234 ↗