Diamondback Peripheral DBP-EX-125MIC145Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10852528005817), received between Oct 23, 2020 and Aug 26, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that target vessel was heavily calcified superficial femoral artery (SFA) to popliteal to tibial peroneal trunk(TPT) to posterior tibial (PT) to pedal loop. The lesion was greater than 70% throughout each artery, approximately 450 cm in total disease length treated. The physician was able to easily navigate an 0.014 through the calcified disease and around the pedal loop with an 0.014 non-Abbott guidewire. It was then swapped for an 0.014 Viperwire Peripheral guidewire. Atherectomy was performed up to medium speed using a A Diamondback 360 Peripheral Exchange Orbital Atherectomy Device (OAD) in popliteal-TPT-PT. Then the cartridge on the Exchangeable device was swapped for a micro crown which was used to perform atherectomy in the pedal loop. It was noted flushing was performed between each run and 30 seconds of treatment to rest was also followed. ACT was drawn and within normal range for intervention. Embolization of the distal vessels in the patient¿s foot occurred as a result of orbital atherectomy system. Angioplasty was performed using balloons of varying sizes and it was noted that flow had been lost in the PT and down the pedal loop. It was a case of persist

  Patient problems: Embolism/Embolus; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 50459610 ↗
• InjuryDec 8, 2025Entrapment of Device; Unexpected Shutdown; Device Contaminated at the User Facility; Entrapment of Device; Unexpected Shutdown; Device Contaminated at the User Facility

  IT WAS REPORTED THAT DURING PROCEDURE TO TREAT LESION IN CALCIFIED, HIGHLY TORTUOUS, 85% STENOSED DISTAL DORSALIS PEDIS ARTERY (DP), THE 1.25 MICRO DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SHUT OFF DURING FIRST RUN. THE VESSEL DIAMETER WAS 2.00MM. THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP WAS EXCHANGED FROM A NON-ABBOTT WIRE. DURING REMOVAL, IT WAS NOTED THAT THE OAD BECAME ENTANGLED IN THE DISSECTION FLAP. THERE WAS NO DISSECTION BEFORE THE PROCEDURE. THE DISSECTION WAS NOT SEEN ANGIOGRAPHICALLY BUT THE PHYSICIAN THOUGHT IT WAS A SMALL FLAP THAT THE CROWN GOT STUCK ON. THE OAD AND THE VIPERWIRE COULD NOT BE REMOVED DUE TO THE VIPERWIRE BEING FRACTURED AND STUCK IN THE VESSEL. A CUT DOWN PROCEDURE WAS PERFORMED FOR REMOVAL, AND THE PHYSICIAN WAS ABLE TO REMOVE THE CROWN, BUT THE ENTIRE RADIOPAQUE SECTION OF THE VIPERWIRE TIP WAS LEFT IN THE LEG AS THERE WAS NO LONGER ACCESS TO THE VESSEL. WIRE ACCESS WAS LOST DUE TO THE VIPERWIRE BEING STUCK IN THE VESSEL DISTAL TO THE CROWN THAT WAS STUCK IN THE VESSEL WALL. THE VIPERWIRE RADIOPAQUE TIP WAS LEFT IN THE FOOT AND THE CUT DOWN TO REMOVE THE CROWN WAS SUTURED CLOSED. THE DISSECTION WAS N

  Patient problems: Vascular Dissection

  MAUDE report 23749708 ↗
• InjuryDec 13, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  IT WAS REPORTED THAT A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF THE DISTAL ANTERIOR TIBIAL ARTERY VIA FEMORAL ACCESS. THE LESION WAS 2.0 MM IN DIAMETER, 95% STENOSED, HEAVILY CALCIFIED AND MILDLY TORTUOUS. UPON ADVANCING THE OAD ON LOW SPEED FOR THE FIRST TIME TO THE DISTAL LESION BY THE ANKLE, THE OAD BECAME STUCK AND SHUT DOWN, CONSISTENT WITH SAFETY MECHANISM. THE OAD COULD NOT BE RETRACTED. MANIPULATION OF THE CROWN WAS ATTEMPTED USING GLIDEASSIST TO RETRACT THE OAD OVER THE VIPERWIRE WITH NO SUCCESS. AN INCISION WAS MADE AT THE FOOT TO SUCCESSFULLY FREE THE CROWN. THE OAD WAS REMOVED. THE PATIENT WAS STABLE. THE PHYSICIAN BELIEVES THE OAD BECAME STUCK DUE TO PATIENT ANATOMY AND DISEASE. ON (B)(6) 2024, THE ABBOTT SENIOR RELIABILITY TECHNICIAN INDICATED THAT THE OAD DRIVESHAFT WAS RECEIVED FRACTURED AT THE CROWN AREA AND THE DISTAL FRACTURED SECTION WAS RETURNED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20924237 ↗
• InjuryAug 9, 2024Unintended System Motion; Unexpected Shutdown; Unintended System Motion; Unexpected Shutdown

  DURING A PERIPHERAL PROCEDURE TO TREAT A CALCIFIED LESION IN DISTAL PERONEAL ARTERY USING A DIAMONDBACK EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WITH ANTEGRADE FEMORAL APPROACH, THE OAD STALLED ON HIGH SPEED AFTER SUCCESSFUL TREATMENTS ON LOW AND MEDIUM SPEEDS AND THE DISTAL WIRE ACCESS WAS LOST. IT WAS REWIRED AND INTERVENTION WAS CONTINUED FOLLOWED BY PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE OAD AND VIPERWIRE WERE REMOVED TOGETHER. VESSEL SPASM OCCURRED IN THE PATIENT. HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NITROGLYCERIN AND ADENOSINE WERE ADMINISTERED TO TREAT VESSEL SPASM. THE PATIENT WAS IN STABLE CONDITION. IN THE PHYSICIAN'S OPINION, THE OAD CAUSED AND CONTRIBUTED TO VESSEL SPASM IN THE PATIENT.

  Patient problems: Vasoconstriction

  MAUDE report 19949396 ↗
• InjuryJan 12, 2024Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN THE (TPT) TIBIOPERONEAL TRUNK AND OSTIAL POSTERIOR TIBIAL (PT). DURING THE SECOND TREATMENT, THE OAD WAS SPUN ON MEDIUM SPEED AND THE OAD STOPPED SPINNING AND BECAME STUCK IN THE VESSEL. THERE WERE NO CLEAR INDICATION AS TO WHY THE OAD BECAME STUCK. ATTEMPTS TO REMOVE THE OAD WERE UNSUCCESSFUL AND CAUSED A MAJOR DELAY. THE PATIENT WAS SENT TO SURGERY TO HAVE THE OAD REMOVED. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18502340 ↗
• MalfunctionApr 21, 2023Material Separation; Material Separation

  AS THE DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS ABOUT TO BE LOADED ONTO THE WIRE, IT WAS OBSERVED THAT THE SHEATHING COVERING THE DRIVESHAFT WAS DISCONNECTED AND SLIDING TOWARDS THE DISTAL END OF THE DRIVESHAFT. THE OAD WAS REPLACED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789799 ↗
• InjuryMar 9, 2023Difficult to Remove; Difficult to Remove

  UPON INITIAL ACCESS, THE DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) CROWN WAS HAVING DIFFICULTY ADVANCING PAST A BEND IN THE PROXIMAL PERONEAL, AND GLIDEASSIST WAS NEEDED TO ADVANCE TO THE TARGET LESION. LOW SPEED AND MEDIUM SPEED TREATMENTS WERE PERFORMED ON THE LESION. THE PHYSICIAN ATTEMPTED A HIGH-SPEED TREATMENT, WHICH LED TO THE OAD RUNWAY LIGHTS ILLUMINATING. UPON ATTEMPTING TO REMOVE THE OAD, IT BECAME STUCK, THE OAD WAS NOT TURNING ON, AND RUNWAY LIGHTS ILLUMINATED ONCE AGAIN. THE PHYSICIAN WAS UNABLE TO USE GLIDEASSIST AND COULD NOT SPIN. A SECOND OAD HANDLE WAS PLACED ONTO THE CARTRIDGE TO PERFORM TROUBLESHOOTING. RUNWAY LIGHTS ILLUMINATED AGAIN, AND NO SPINNING WAS PERFORMED. THE OAD WAS ABLE TO BE REMOVED AFTER FOUR HOURS OF ATTEMPTING TO REMOVE THE DEVICE. THE OAD WAS VISUALLY INSPECTED AND THERE WERE NO ABNORMALITIES OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16515956 ↗
• InjuryAug 24, 2022Mechanical Problem; Unintended System Motion; Mechanical Problem; Unintended System Motion

  DURING THE SECOND TREATMENT OF THE DORSALIS PEDIS (DP) ARTERY WITH THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD), THE CROWN JUMPED BACKWARDS AND STOPPED SPINNING. THE OAD WAS REMOVED, AND A PERFORATION OF THE DP ARTERY WAS OBSERVED. BALLOON ANGIOPLASTY WAS ATTEMPTED TO RESOLVE THE PERFORATION. A NON-CSI BALLOON WAS UNABLE TO CROSS THE LESION AND BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE. ANOTHER ATTEMPT WAS MADE WITH A DIFFERENT NON-CSI BALLOON, HOWEVER, THE ISSUE PERSISTED. THE WIRE AND BALLOON WERE REMOVED AND A KINK PROXIMAL OF THE SPRING TIP WAS OBSERVED ON THE WIRE. NO FURTHER INTERVENTION WAS PERFORMED TO RESOLVE THE PERFORATION. THE PATIENT WAS STABLE, AND THE PERFORATION WILL CONTINUE TO BE MONITORED.

  Patient problems: Perforation of Vessels

  MAUDE report 15284177 ↗
• InjuryJul 25, 2022Difficult to Remove; Difficult to Remove

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED INTO THE DISTAL POSTERIOR TIBIAL NEAR THE PLANTAR AREA USING A 7FR SHEATH. TWO RUNS WERE MADE, ONE ON LOW SPEED AND ONE ON MEDIUM SPEED. AFTERWARDS, THE OAD BECAME STUCK. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE DEVICE WITH GLIDE ASSIST, A SMALL BALLOON, AND LASTLY AN ATTEMPT TO CUT IN FRONT OF THE DEVICE TO REMOVE THE SHEATH AND DRIVE SHAFT, HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT WAS SENT FOR SURGERY AND THE OAD WAS REMOVED. THE PATIENT WAS STABLE BEFORE, DURING, AND AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093755 ↗
• InjuryJun 17, 2022Material Separation; Material Separation

  A DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT DISTAL TO PROXIMAL IN THE PEDAL LOOP IN FOUR MAIN LESIONS. A LESION IN THE MID PEDAL ARCH WAS LONG AND DIFFUSELY DISEASED. THE VESSELS WERE MORE THAN 90% STENOSED AND SEVERELY CALCIFIED. THE DIAMETER RANGED FROM 2.5MM TO 3.5MM IN THE SUCCESSFULLY TREATED LESIONS AND ABOUT 2 MM WHERE THE OAD STOPPED SPINNING. THE OAD WAS ADVANCED FROM THE OSTIUM TO THE POSTERIOR TIBIAL (PT) ARTERY, AND LATERAL TO THE PT. FROM THE POSTERIOR TIBIAL (PT) ARTERY TO THE ANKLE TREATMENT WAS PERFORMED ON MEDIUM SPEED. TREATMENT WAS PERFORMED ON LOW SPEED BELOW THE ANKLE. APPROXIMATELY 3CM INTO THE PEDAL ARCH THE DEVICE STOPPED SPINNING. GLIDEASSIST WAS ACTIVATED, BUT THE ATTEMPT TO REMOVE THE DEVICE WAS UNSUCCESSFUL. EXCESSIVE FORCE WAS USED TO PULL ON THE DRIVESHAFT AND IT FRACTURED. THE DRIVESHAFT BECAME UNCOILED FROM THE PEDAL ARCH TO THE DISTAL PT. THE SALINE SHEATH BECAME LOOSE AND WAS EX VIVO. UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE FRAGMENT AND TO DISLODGE THE CROWN. THE BALLOON WAS ADVANCED CROSSING FROM THE ANTERIOR TIBIAL (AT) ARTERY TO THE PEDAL LOOP. REVASCULARIZATION WAS PERFORMED USING BALLOON ANGIOPLA

  Patient problems: Foreign Body In Patient

  MAUDE report 14734848 ↗
• InjuryFeb 15, 2022Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY SYSTEM (OAD) WAS SELECTED FOR TREATMENT OF A PATIENT WHO HAD PRE-EXISTING NO FLOW IN THE ANTERIOR TIBIAL ARTERY AND WAS EXPERIENCING PAIN. THE OAD WAS OPERATED IN THE AT ARTERY ON LOW AND MEDIUM SPEED WITHOUT ISSUE AND THEN ADVANCED TO THE MID AT, HOWEVER THE DEVICE SOUNDED AS THOUGH IT WERE WRAPPED AROUND TISSUE. THE CONTROL KNOB WAS LOCKED AND THE CROWN WAS RETRACTED, HOWEVER THE CROWN WOULD NOT MOVE AS IT WAS STUCK IN THE VESSEL AND THE PATIENT EXPERIENCED PAIN. NITROGLYCERIN AND VERAPAMIL WERE ADMINISTERED TO LOOSEN THE VESSEL, DUE TO A SPASM THAT HAD OCCURRED, HOWEVER THIS WAS UNSUCCESSFUL. DUE TO THE SIZE OF THE SHEATH, BALLOONS AND GUIDE CATHETERS COULD NOT BE ADVANCED OVER THE CROWN. THE OAD WAS MANUALLY TUGGED, BUT THE CROWN REMAINED STUCK. GLIDEASSIST MODE WAS ACTIVATED AND THE CROWN MOVED A FEW INCHES, BUT THEN STOPPED AND THE PATIENT EXPERIENCED ADDITIONAL PAIN. DURING ATTEMPTS TO REMOVE THE OAD, THE OAD BECAME STRETCHED. THE DRIVESHAFT WAS CUT AND REMOVED FROM THE SALINE SHEATH. THE CATHETER WAS STILL IN PLACE WITH THE CROWN IN THE PROXIMAL AT. A CATHETER WAS ADVANCED AND PLACED BY THE CROWN. PULLING AND MANIPULATION OF

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Blood Pressure/ Hypotension; Pain

  MAUDE report 13533855 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A GANGRENOUS WOUND TO THE RIGHT FIRST TOE WITH DORSALIS PEDIS (DP) AND POSTERIOR TIBIAL (PT) PULSES. PRE-INTERVENTION ANGIOGRAM DEMONSTRATED COMPLETE PT AND PERONEAL ARTERY RUNOFF. THE ANTERIOR TIBIAL (AT) ARTERY DEMONSTRATED APPRECIABLY SLOW FLOW. SELECTIVE ANGIOGRAPHY REVEALED A SHORT, DISTAL, TOTAL OCCLUSION ABOUT 5CM IN LENGTH, WHICH WAS RECONSTITUTED AND FED COLLATERALLY BY THE PERONEAL ARTERY, ULTIMATELY PROVIDING DORSALIS PEDIS FLOW. AFTER AN UNSUCCESSFUL ATTEMPT AT ANGIOPLASTY AT THE FOCAL DP LESION, A DIAMONDBACK EXCHANGEABLE SERIES PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF THE DISTAL HALF OF THE AT. TWO TREATMENTS WERE PERFORMED ON LOW SPEED, AND ONE TREATMENT WAS PERFORMED ON MEDIUM SPEED. GLIDEASSIST WAS USED TO REMOVE THE OAD, AND ANGIOPLASTY WAS PERFORMED. POST INTERVENTIONAL ANGIOGRAM AGAIN DEMONSTRATED SLOW FLOW THROUGH THE AT WITH ONLY TRACE PERFUSION TO THE FOOT. THE FORMERLY TOTALLY OCCLUDED SEGMENT OF VESSEL WHICH WAS TREATED APPEARED PATENT AND FREE OF DISSECTION. ALTHOUGH NO ATTEMPT WAS MADE TO TREAT THEM, THE PT AND PERONEAL ARTERIES DEMONSTRATED VERY SLUGGISH OUTFLOW. THE PHYSICIAN BELIEVED THIS WAS

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

  MAUDE report 13412245 ↗
• InjuryDec 21, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR A PATIENT WHO HAD A PLANNED TRANSMETATARSAL AMPUTATION (TMA) IMMEDIATELY FOLLOWING THE ORBITAL ATHERECTOMY PROCEDURE. THE OAD WAS USED TO PERFORM THREE TREATMENT PASSES AND DURING THE REMOVAL PROCESS BECAME STUCK IN THE VESSEL AND WAS UNABLE TO BE REMOVED. GLIDEASSIST MODE WAS ACTIVATED HOWEVER THE OAD COULD NOT BE REMOVED. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM THAT WAS ALREADY PREPPED FOR THE TMA AND AN INCISION WAS MADE SLIGHTLY ABOVE WHERE THE TMA WAS TO BE PERFORMED TO SURGICALLY REMOVE THE OAD. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13055996 ↗
• InjuryJul 14, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK EXCHANGEABLE SERIES ORBITAL ATHERECTOMY DEVICE (OAD) WAS REPOSITIONED TO THE ANTERIOR TIBIAL ARTERY (AT) FOLLOWING SUCCESSFUL TREATMENT OF THE RIGHT PERONEAL ARTERY. IMAGING WAS PERFORMED AND CONFIRMED PLACEMENT OF THE EXCHANGE WIRE IN THE TRUE LUMEN OF THE VESSEL. THE DEVICE STOPPED SPINNING DURING TREATMENT OF THE DISTAL SEGMENT OF THE AT. THE GLIDEASSIST FUNCTION WAS ACTIVATED, BUT IT REPEATEDLY STOPPED SPINNING. THE OAD BECAME STUCK IN THE VESSEL; THE OAD COULD NOT BE REMOVED FROM THE VESSEL DESPITE ADMINISTRATION OF NITROGLYCERIN. THE WIRE AND OAD WERE COILED, AND A PATCH WAS PLACED ON THE SHEATH. THE PATIENT WAS STABLE BUT WAS SENT TO SURGERY FOR REMOVAL OF THE DEVICE. AFTER REVIEW OF THE PROCEDURE FILMS, IT WAS DETERMINED THE OAD AND VIPERWIRE HAD BEEN PLACED IN A COLLATERAL VESSEL WITH A SIMILAR PATH OF THE TRUE AT. THE REMOVAL SURGERY WAS PERFORMED (B)(6) 2021, AND THE LOWER EXTREMITY HAD PULSES.

  Patient problems: Foreign Body In Patient

  MAUDE report 12166474 ↗
• MalfunctionMar 16, 2021Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  DURING ORBITAL ATHERECTOMY TREATMENT TO THE PROXIMAL ANTERIOR TIBIAL ARTERY, FLUID WAS OBSERVED TO BE LEAKING FROM THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD), AND THE SALINE SHEATH WAS DETACHED. THE VESSEL WAS NOT BEING PERFUSED, AND PER THE PHYSICIAN THE FLOW OF SALINE TO THE TIP OF THE OAD WAS NOT SUFFICIENT ENOUGH TO PREVENT PATIENT INJURY. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE, WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496289 ↗
• InjuryNov 20, 2020Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT TWO LESIONS IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND DIFFUSE ANTERIOR TIBIAL ARTERY (AT). ONE TREATMENT PASS WAS PERFORMED ON LOW SPEED IN THE SFA, FOLLOWED BY THREE TREATMENT PASSES ON LOW, MEDIUM AND HIGH SPEEDS IN THE PROXIMAL AT. THE OAD WAS ADVANCED TO THE DISTAL AT AND FOLLOWING ONE TREATMENT PASS ON LOW SPEED, THE OAD STOPPED AND WAS STUCK IN THE VESSEL. ATTEMPTS WERE MADE TO REMOVE THE CROWN MANUALLY AND WITH GLIDEASSIST, BUT WERE NOT SUCCESSFUL. THE OAD DRIVESHAFT WAS CUT, ACCESS WAS OBTAINED VIA THE DORSALIS PEDIS, AND A SNARE WAS USED TO REMOVE THE DEVICE VIA THE PEDAL ARCH. A SMALL PERFORATION WAS THEN NOTED IN THE AT, AND WAS RESOLVED WITH TWO BALLOON INFLATIONS. THERE WERE NO ADDITIONAL COMPLICATIONS NOTED FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels

  MAUDE report 10877492 ↗
• InjuryNov 17, 2020Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE EXCHANGEABLE SERIES (OAD) BECAME STUCK IN THE PEDAL LOOP FOLLOWING SEVERAL SUCCESSFUL TREATMENTS. THE DRIVESHAFT WAS CUT, AND A SNARE WAS UNSUCCESSFUL IN REMOVING THE OAD. THE PATIENT WAS SENT TO SURGERY. DURING THE SURGERY, A PERFORATION WAS IDENTIFIED, AND IT APPEARED THE OAD HAD BECOME WRAPPED IN VASCULAR TISSUE. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 10852598 ↗
• MalfunctionOct 23, 2020Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE EXCHANGEABLE SERIES (OAD) BECAME STUCK ON THE WIRE WHEN IT WAS PULLED BACK FOLLOWING TREATMENT IN THE POSTERIOR TIBIAL ARTERY VIA FEMORAL RETROGRADE APPROACH. THE OAD AND WIRE WERE REMOVED TOGETHER. WIRE ACCESS WAS LOST BUT WAS REGAINED FOR ANGIOPLASTY. REGAINING WIRE ACCESS DELAYED THE PROCEDURE BY 30 MINUTES OR MORE DUE TO TIME NEEDED TO REWIRE THE VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10725700 ↗