Stealth PRD-SC30-200 (REF 70056-06)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10852528005053), received between Sep 9, 2015 and Oct 27, 2021 — classified as 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS OPERATED FOR THREE TREATMENT PASSES AND BECAME STUCK ON THE GUIDE WIRE. THE OAD AND WIRE WERE REMOVED AND A PINHOLE WAS OBSERVED ON THE OUTSIDE OF THE SHEATH. BLOOD WAS ALSO OBSERVED WITHIN THE DRIVESHAFT, NEAR THE PINHOLE. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708094 ↗
• MalfunctionDec 21, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A HEAVILY STENOSED LESION IN THE COMMON FEMORAL ARTERY (CFA) VIA BRACHIAL ACCESS. THE OAD WAS POSITIONED USING SIGNIFICANT FORCE, AND AS THE OAD ENGAGED THE LESION, A POPPING SOUND WAS HEARD. THE OAD WAS TURNED OFF, AND IT WAS NOTED THAT THE CONTROL KNOB AND CROWN WERE NOT MOVING AT A 1:1 RATIO. THE OAD AND GUIDE WIRE WERE REMOVED, AND THE CROWN WAS OBSERVED TO MOVE INDEPENDENTLY OF THE CONTROL KNOB. THE LESION WAS DIFFICULT TO REWIRE, AND THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY, AND NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11046535 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) VIA POPLITEAL ACCESS. THE LESION WAS WIRED, AND INTRAVASCULAR ULTRASOUND WAS USED. THE GUIDE WIRE WAS CLEARLY SUBINTIMAL AND NOT IN THE TRUE LUMEN. THE PHYSICIAN DECIDED TO MOVE FORWARD DESPITE THE PLACEMENT OF THE WIRE IN THE SUBINTIMAL SPACE. HE TREATED THE LESION WITH OA ON LOW SPEED, AND THE PATIENT COMPLAINED OF DISCOMFORT. HIGH SPEED WAS SELECTED, AND THE OAD MADE A LOUD SOUND THAT HAD NOT BEEN HEARD ON LOW OR MEDIUM SPEED. ONE OF THE LEDS ON THE OAD HANDLE BLINKED AT THE SAME TIME AS THE LOUD NOISE. THE OAD WAS REMOVED, AND BALLOON ANGIOPLASTY WAS PERFORMED. IMAGING WAS PERFORMED AFTER ANGIOPLASTY, AND A PERFORATION AND VESSEL INJURY WERE OBSERVED. IT WAS NOTED THE OAD CONTRIBUTED TO THE PERFORATION AND VESSEL INJURY. TWO COVERED STENTS WERE PLACED TO TREAT THE PERFORATION. THE PATIENT WAS TRANSFERRED TO THE HOSPITAL AND HAD A FASCIOTOMY TO RESOLVE REMAINING PRESSURE AT THE INJURY SITE ON (B)(6) 2020. AS OF (B)(6) 2020, THE PATIENT WAS STABLE AND HOSPITALIZED.

  Patient problems: No Code Available; Perforation of Vessels

  MAUDE report 10460942 ↗
• MalfunctionJul 14, 2020Material Integrity Problem; Material Integrity Problem

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING ANALYZED FOR AN ISSUE THAT WAS NOT CONSIDERED REPORTABLE. HOWEVER, DURING FAILURE ANALYSIS, A FRACTURE WAS IDENTIFIED.

  Patient problems: Missing Value Reason

  MAUDE report 10270165 ↗
• MalfunctionMay 26, 2020Failure to Advance; Failure to Advance

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE DELIVERED OVER THE AORTIC BIFURCATION THROUGH A 6FR SHEATH. A 7FR SHEATH WAS THEN USED AS A TROUBLESHOOTING MEASURE, BUT THE OAD STILL COULD NOT BE ADVANCED OVER THE BIFURCATION THROUGH THE SHEATH. THE PROCEDURE WAS ABORTED DUE TO THE INABILITY TO DELIVER THE DEVICE AND CONCERNS REGARDING ELEVATED BLOOD PRESSURE. THE ELEVATED BLOOD PRESSURE WAS NOT ATTRIBUTED TO THE OAD. IN THE OPINION OF THE PHYSICIAN, THE OAD SHOULD HAVE BEEN ABLE TO TRAVERSE EITHER SHEATH AND THE BIFURCATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10087936 ↗
• InjuryMar 23, 2020Material Separation; Material Separation

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT IN THE COMMON FEMORAL ARTERY VIA 6FR ACCESS. THE DRIVESHAFT OF THE OAD BROKE DURING AN ATTEMPT TO ADVANCE THE OAD OVER THE BIFURCATION. A COMPETITOR CATHETER WAS INSERTED IN ORDER TO PULL THE GUIDE WIRE AND FRAGMENT OF OAD INTO THE SHEATH AND OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMALLER OAD AND ANGIOPLASTY WITH EXCELLENT RESULTS AND MINIMAL DELAY. THE PATIENT WAS STABLE AND WAS DISCHARGED WITHOUT COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9864873 ↗
• MalfunctionFeb 4, 2020Entrapment of Device; Entrapment of Device

  THE SHEATH OF THE STEALTH ORBITAL ATHERECTOMY DEVICE WAS KINKED, AND THE GUIDE WIRE COULD NOT BE ADVANCED THROUGH IT. THE PROCEDURE WAS COMPLETED WITH A SECOND OAD. THE PROCEDURE WAS DELAYED BY 30 MINUTES OR MORE DUE TO THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 9667970 ↗
• MalfunctionDec 9, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PREPARED AND INSERTED AS USUAL. FOLLOWING THREE TREATMENT PASSES OF A 95% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), BLOOD WAS NOTED TO BE BACKING UP INTO THE DEVICE. AN ATTEMPT WAS MADE TO FLUSH AND PRIME THE DEVICE AND TO ADJUST THE TUBING, HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE OAD WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440015 ↗
• InjurySep 4, 2019Entrapment of Device; Stretched; Entrapment of Device; Stretched

  THE STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) SHEATH BECAME STUCK IN THE ILIAC BIFURCATION, AND THE DRIVESHAFT BECAME STRETCHED. THE ILIAC BIFURCATION HAD A NARROW DIAMETER. ADDITIONAL ACCESS WAS OBTAINED ON THE OPPOSITE SIDE TO PUSH THE DEVICE BACK, AND THE OAD WAS ABLE TO BE REMOVED. NO FRACTURES OCCURRED, AND THE PROCEDURE TIME WAS EXTENDED BY ALMOST AN HOUR.

  Patient problems: Injury

  MAUDE report 8959719 ↗
• InjuryJun 21, 2019Entrapment of Device; Entrapment of Device

  DURING TREATMENT OF A CALCIFIED LESION IN THE TIBIOPERONEAL (TP) TRUNK WITH A CSI STEALTH ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE WAS INADVERTENTLY OPERATED INSIDE OF A PREVIOUSLY PLACED STENT AND BECAME STUCK. IT WAS UNKNOWN THAT A PREVIOUSLY PLACED STENT WAS PRESENT IN THIS LOCATION. PER THE PHYSICIAN, THE ARCH WAS HIGHLY TORTUOUS AND THE CROWN USED MAY HAVE BEEN TOO LARGE FOR THE VESSEL. THE OAD, GUIDE WIRE AND STENT WERE REMOVED BY PULLING ON THE GUIDE WIRE, AND ALL DEVICES WERE REMOVED FROM THE PATIENT. THE LESION WAS RE-ACCESSED AND THE AREA WAS TREATED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS STABLE AND DISCHARGED THE DAY OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8721742 ↗
• MalfunctionMay 22, 2019Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING AND BECAME STUCK IN A HIGHLY CALCIFIED LESION IN THE SUPERIOR FEMORAL ARTERY. THE GUIDE CATHETER, WHICH WAS ALREADY IN VIVO, WAS ADVANCED OVER THE CROWN TO FREE THE OAD. THE PROCEDURE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8633881 ↗
• MalfunctionMay 7, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE CROWN OF THE DEVICE BECAME DETACHED. DURING TREATMENT OF A LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA), MULTIPLE PASSES WERE PERFORMED WITH THE OAD AROUND A TIGHT ARCH AND THE DEVICE STOPPED SPINNING. UPON REMOVAL, THE OAD BECAME STUCK IN A NON-CSI SHEATH AND A PORTION OF THE DEVICE BECAME DETACHED. THE OAD WAS REPLACED AND A LARGER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. IT WAS CONFIRMED THAT NO PORTION OF THE OAD REMAINED IN THE PATIENT, AND NO INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE FRAGMENT FROM THE BODY. PER THE PHYSICIAN, THE CAUSE OF THIS EVENT WAS THE HIGH TORTUOSITY OF THE VESSEL AND THE CALCIUM PRESENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8587538 ↗
• InjuryApr 8, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING A PROCEDURE, THE CROWN ON THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BROKE OFF. THE TARGET LESION WAS A 15 CM LONG, DIFFUSELY CALCIFIED AND 90% STENOSED LESION LOCATED IN THE 6MM, TORTUOUS COMMON FEMORAL ARTERY. DURING THE SECOND TREATMENT, THE OAD BECAME STUCK IN THE LESION. THE PHYSICIAN PULLED AND TORQUED THE OAD IN AN ATTEMPT TO REMOVE THE OAD, AND THE CROWN OF THE DRIVESHAFT BROKE OFF. IT WAS NOTED THAT THE DEVICE FRAGMENT WAS SNARED, AND NO PART OF THE DEVICE WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY, AND THE PATIENT WAS DISCHARGED THE SAME DAY OF THE PROCEDURE. DEVICE ANALYSIS IDENTIFIED THE FRACTURE OCCURRED AT THE LAP WELD, NOT THE CROWN. IT WAS CONFIRMED THE CORRECT DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: Foreign Body In Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 8491072 ↗
• InjuryApr 2, 2019Material Separation; Material Separation

  DURING A PROCEDURE, THE TIP OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BROKE OFF. A 30MM, SEVERELY CALCIFIED LESION THAT WAS 95% STENOSED WAS LOCATED IN THE PROXIMAL ANTERIOR TIBIAL (AT) ARTERY. THE VESSEL DIAMETER WAS 4.0MM AND WAS NOT TORTUOUS. THE POSTERIOR TIBIAL (PT) ARTERY WAS ACCESSED, AND THE OAD WAS TRACKED UP THE PT AND DOWN INTO THE AT THE LESION SITE. AT THE END OF THE OAD TREATMENT IT WAS NOTED A 30MM PORTION OF THE TIP OF THE OAD HAD BROKEN OFF. THE FRACTURED PORTION REMAINED ON THE GUIDE WIRE AND WAS CAPTURED WITH A NON-CSI CATHETER FROM A PEDAL APPROACH. NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. IT WAS REPORTED THAT A STEEP ANGLE WAS PRESENT IN THE VESSEL. THE PATIENT STATUS WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8473324 ↗
• InjuryJun 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), AN EMBOLIZATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). FOLLOWING TREATMENT WITH THE OAD AND BALLOON ANGIOPLASTY, EMBOLIZATION WAS NOTED DISTAL TO THE TREATMENT AREA. AN ASPIRATION THROMBECTOMY WAS PERFORMED ALONG WITH LASER ATHERECTOMY AND ADDITIONAL BALLOON ANGIOPLASTY AT THE EMBOLIZATION SITE TO IMPROVE FLOW. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Embolus

  MAUDE report 7597399 ↗
• InjuryJun 4, 2018Device Operational Issue; Device Operational Issue

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS TREATED USING ONE PASS ON LOW SPEED WITH THE OAD. FOLLOWING THE FIRST PASS, THE OAD SHUT DOWN AND WOULD NO LONGER FUNCTION. THE LESION WAS THEN TREATED WITH BALLOON ANGIOPLASTY AND IMAGING REVEALED A DISSECTION IN THE AREA OF ATHERECTOMY TREATMENT. THE DISSECTION WAS TREATED WITH THE PLACEMENT OF AN UNPLANNED STENT AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7567151 ↗
• MalfunctionMay 22, 2018Break; Difficult to Advance; Break; Difficult to Advance

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE WAS UNABLE TO PASS THROUGH THE SHEATH, RESULTING IN A PROCEDURAL DELAY. THE OAD WAS UNABLE TO PASS THROUGH THE 6F SHEATH IN THE DISTAL SUPERFICIAL FEMORAL ARTERY. THE SHEATH WAS REPLACED TO A 7F SHEATH, HOWEVER WHEN LOADING THE OAD ONTO THE GUIDE WIRE IT WOULD NOT ADVANCE AND THE NOSE CONE WAS NOTED TO BE DAMAGED. FOLLOWING A THIRTY MINUTE DELAY, THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533792 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THE TARGET LESION WAS HEAVILY CALCIFIED AND REQUIRED MULTIPLE ATTEMPTS TO ACCESS. THE VIPERWIRE WAS PASSED THROUGH A GLIDE CATHETER AND PLACED DISTAL TO THE LESION. WHEN ATTEMPTING TO FLUSH THE SHEATH PRIOR TO INSERTING THE OAD, THE SHEATH WAS NOTED TO BE CLOTTED. THE SHEATH WAS REMOVED AND THE GUIDEWIRE AND GUIDE CATHETER WERE REVERSED ACROSS THE ILIAC CREST. A THROMBUS WAS NOTED IN THE SUPERFICIAL FEMORAL ARTERY AND THE PROCEDURE WAS ABORTED. AN ANTICOAGULANT WAS ADMINISTERED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Thrombus

  MAUDE report 7114112 ↗
• MalfunctionNov 2, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE PHYSICIAN WAS UNABLE TO CHANGE SPEEDS ON THE DEVICE. THE TARGET LESION WAS 10 MM IN LENGTH, 90% STENOTIC AND WAS LOCATED IN THE COMMON FEMORAL ARTERY (CFA). WHILE TREATING WITH THE CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE PHYSICIAN WAS UNABLE TO CHANGE SPEEDS. A SECOND OAD WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6996604 ↗
• InjuryMay 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A DISSECTION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 20MM IN LENGTH AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN ACCESSED THE LESION USING A 6FR INTRODUCER SHEATH AND A CSI VIPERWIRE GUIDE WIRE. THE OAD WAS LOADED ONTO THE GUIDE WIRE AND THE PHYSICIAN PERFORMED MULTIPLE RUNS AT LOW, MEDIUM AND HIGH SPEED. THE OAD WAS REMOVED AND ATHERECTOMY WAS FOLLOWED-UP WITH BALLOON ANGIOPLASTY. POST-ANGIOPLASTY ANGIOGRAPHY REVEALED A SPIRAL DISSECTION IN THE SFA. THE PHYSICIAN DEPLOYED A COVERED STENT AND RESOLVED THE DISSECTION. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. A REQUEST WAS MADE FOR ADDITIONAL INFORMATION, BUT WAS DENIED BY THE FACILITY DUE TO INTERNAL POLICIES.

  Patient problems: Vascular Dissection

  MAUDE report 5666325 ↗
• InjuryDec 14, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A NO FLOW EVENT OCCURRED AFTER USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 70% STENOTIC, 30MM IN LENGTH AND WAS LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN USED A 6FR/45CM INTRODUCER SHEATH AND A J-WIRE GUIDE WIRE TO ACCESS THE LESION. THE J-WIRE WAS EXCHANGED FOR A CSI VIPERWIRE GUIDE WIRE AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN PERFORMED TWO RUNS AT LOW SPEED, TWO RUNS AT MEDIUM SPEED AND TWO RUNS AT HIGH SPEED. THE PHYSICIAN FOLLOWED-UP ATHERECTOMY BY PERFORMING LOW PRESSURE BALLOON ANGIOPLASTY. POST-ANGIOPLASTY ANGIOGRAPHY REVEALED A DISTAL OCCLUSION AND NO FLOW. THE PHYSICIAN RESOLVED THE OCCLUSION VIA AN ASPIRATION CATHETER. ADDITIONALLY, A HEMATOMA HAD DEVELOPED IN THE PROCESS OF EXCHANGING FOR THE ASPIRATION CATHETER, BUT WAS EVENTUALLY RESOLVED. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE, BUT WAS DENIED BY THE FACILITY DUE TO INTERNAL POLICIES.

  Patient problems: No Code Available

  MAUDE report 5295471 ↗
• InjuryDec 4, 2015Retraction Problem; Device Operates Differently Than Expected; Difficult to Advance

  ADDITIONALLY, IT WAS IDENTIFIED THAT, AFTER REMOVAL OF THE OAD, THE ANGIOGRAPHY REVEALED AN OBSTRUCTING THROMBUS OR ENDARTERECTOMY SEGMENT IN THE CFA WITH EMBOLIZATION TO THE PROFUNDA AND THE SFA WAS OCCLUDED. THE PATIENT WAS THEN TAKEN TO THE OR FOR THROMBOENDARTERECTOMY AND FEMORAL POPLITEAL BYPASS.

  Patient problems: Vascular Dissection

  MAUDE report 5266989 ↗
• InjurySep 22, 2015Adverse Event Without Identified Device or Use Problem

  ADDITIONALLY, IT WAS IDENTIFIED THAT THE TARGET LESION ORIGINATED IN THE DISTAL SFA AND EXTENDED INTO THE POPLITEAL ARTERY. PRIOR TO THE THROMBUS EVENT, THE PHYSICIAN TREATED THE SFA USING ONE RUN AT LOW SPEED, ONE RUN AT MEDIUM SPEED AND TWO RUNS AT HIGH SPEED. THE PHYSICIAN THEN PERFORMED ONE RUN AT LOW SPEED IN THE POPLITEAL ARTERY.

  Patient problems: Thrombus

  MAUDE report 5095568 ↗
• InjurySep 9, 2015Device Stops Intermittently; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) BOGGED DOWN WHILE SPINNING. ADDITIONALLY, AN ARTERIAL DISSECTION OCCURRED WHILE USING THE OAD. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE OAD WAS LOADED ONTO THE GUIDEWIRE AND ADVANCED TO THE SITE OF THE LESION. DURING THE SECOND RUN WITH THE OAD, IT BOGGED DOWN AND STOPPED SPINNING. THE DEVICE AND GUIDEWIRE WERE REMOVED AS A UNIT AND ANGIOGRAPHY REVEALED A DISSECTION IN THE SFA. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED. THE FACILITY IS CLEARING THE RELEASE OF INFORMATION THROUGH THEIR RISK MANAGEMENT DEPARTMENT.

  Patient problems: Vascular Dissection

  MAUDE report 5066600 ↗