Diamondback Peripheral DBP-125MICRO145 (REF 7-10024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 10852528005282), received between Dec 17, 2015 and Jan 26, 2021 — classified as 51 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (43 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 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2021Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT VIA LEFT FEMORAL ACCESS IN THE RIGHT ANTERIOR TIBIAL (AT) ARTERY. THE VESSEL SIZE APPEARED TO BE GREATER THAN 2MM. TREATMENT WAS PERFORMED IN THE PROXIMAL AND MID AT. DISTAL TREATMENT WAS PERFORMED ON LOW AND MEDIUM SPEED. HIGH SPEED WAS SELECTED FOR TREATMENT IN THE DISTAL LESION, AND THE OAD STALLED AND BECAME STUCK IN THE VESSEL. IN THE PROCESS OF THE USER ATTEMPTING TO MANIPULATE THE OAD, THE WIRE CAME BACK AND BECAME STUCK IN THE DRIVESHAFT. NITROGLYCERIN WAS ADMINISTERED. A SECOND WIRE COULD NOT BE ADVANCED DUE TO ANATOMICAL CONSIDERATIONS. THE PHYSICIAN CUT THE DRIVESHAFT AND ADVANCED A LARGER SIZED CATHETER OVER THE DRIVESHAFT IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE. THE PATIENT WAS SENT TO THE OPERATING ROOM FOR FURTHER INTERVENTION. THEREAFTER, A POSSIBLE DISSECTION AND INTIMAL DAMAGE WAS OBSERVED. MEDICAL STAFF STATED THE PROCEDURE HAD BEEN A LAST ATTEMPT PRIOR TO AMPUTATION. THE RIGHT LOWER LIMB WAS REPORTEDLY AMPUTATED. THE PATIENT WAS STABLE CONDITION AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11229372 ↗
• MalfunctionAug 4, 2020Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF LESIONS IN THE PERONEAL, POPLITEAL (PT) AND SUPERFICIAL FEMORAL ARTERIES (SFA). THE PERONEAL LESION WAS LOCATED WITHIN A SUBTOTAL CHRONIC TOTAL OCCLUSION AND WAS HEAVILY CALCIFIED. THE OAD WAS OPERATED IN THE PERONEAL ARTERY FOR ONE TREATMENT PASS ON LOW SPEED, AND TWO TREATMENT PASSES ON MEDIUM SPEED. THE OAD WAS STOPPED BETWEEN TREATMENT PASSES TO REST AND ON THE FIRST TREATMENT PASS ON HIGH SPEED THE OAD ABRUPTLY STOPPED SPINNING. THE OAD WAS UNPLUGGED AND RE-PLUGGED INTO THE PUMP, AND ALL LEDS WERE ILLUMINATED AS EXPECTED. THE START BUTTON ON THE CONTROL KNOB WAS PRESSED, AND THE PUMP PRIME RATE INCREASED, HOWEVER THE OAD CROWN WOULD NOT SPIN. THE OAD WAS REMOVED, AND IT WAS OBSERVED TO BE STUCK ON THE VIPER WIRE GUIDE WIRE. THE GUIDE WIRE WAS REMOVED AND A PROCEDURAL DELAY OF OVER THIRTY (30) MINUTES OCCURRED, DUE TO RE-WIRING OF THE LESIONS. TREATMENT WAS COMPLETED WITH A SECOND OAD AND BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DOING WELL AFTER THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364943 ↗
• InjuryApr 2, 2020Entrapment of Device; Unintended System Motion; Entrapment of Device; Unintended System Motion

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 95% STENOSED LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY VIA POSTERIOR TIBIAL ACCESS. THE LESION WAS MODERATELY TO HEAVILY CALCIFIED, AND THE VESSEL WAS 3.5MM IN DIAMETER. THE OAD WAS USED ON LOW SPEED IN A PROXIMAL TO DISTAL DIRECTION, AND WHEN MEDIUM SPEED WAS SELECTED, THE OAD CROWN JUMPED. THE OAD WAS STUCK ON THE WIRE, AND LOW SPEED WAS SELECTED TO LOOSEN IT FROM THE WIRE. THE OAD WAS THEN REMOVED FROM THE PATIENT WITH A LOT OF RESISTANCE. A SMALL, TYPE A DISSECTION WAS OBSERVED AT THE BEND IN THE ANTERIOR TIBIAL ARTERY, AND BALLOON ANGIOPLASTY WAS USED TO RESOLVE THE DISSECTION. THE PHYSICIAN WAS CONCERNED THE OAD MAY HAVE FRACTURED, AND A SECOND OAD WAS USED TO CONTINUE THE PROCEDURE IN THE POSTERIOR TIBIAL ARTERY. NO PHYSICAL DAMAGE WAS OBSERVED ON THE DRIVESHAFT OR GUIDE WIRE. THE RESULT OF THE PROCEDURE WAS GOOD, AND NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 9917936 ↗
• InjuryMar 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION LESION IN THE RIGHT PERONEAL ARTERY, WHICH WAS ABOUT 2MM IN DIAMETER AND 90% STENOTIC. THE OAD BECAME STUCK IN THE VESSEL DURING USE DUE TO PATIENT MOVEMENT. THE PATIENT WAS RESTLESS DURING THE PROCEDURE, AND THE OAD BECAME STUCK WHEN THE PATIENT MOVED THE LOWER LIMB AT THE SAME TIME AS THE LESION WAS BEING AGGRESSIVELY TREATED WITH ATHERECTOMY. THE OAD WAS REMOVED AFTER SOME TROUBLESHOOTING WHICH DID NOT INCLUDE ADDITIONAL INTERVENTION. IMAGING WAS PERFORMED, AND THE IMAGE DID NOT CLEARLY SHOW THE AREA OF INTEREST. THE OAD WAS FULLY REMOVED AT THAT TIME. ANGIOPLASTY WAS THEN PERFORMED, AND IMAGING WAS REPEATED. A PERFORATION WAS IDENTIFIED IN THE PERONEAL ARTERY. THE PERFORATION WAS NOT TREATED; THE PHYSICIAN DETERMINED IT WOULD BE BEST TO AVOID RE-WIRING THE VESSEL AND BALLOONING DUE TO PRE-EXISTING OUTFLOW CONSIDERATIONS. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 9837291 ↗
• MalfunctionNov 1, 2019Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  THE PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS NOTED TO BE LEAKING FROM THE BLACK POWER CABLE AFTER TREATMENT BEGAN. THERE WAS CONCERN ON THE PART OF THE PHYSICIAN THAT NOT ENOUGH VIPERSLIDE WAS BEING DELIVERED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266991 ↗
• MalfunctionOct 16, 2019Unintended System Motion; Unintended System Motion

  THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) SPUN INDEPENDENTLY WITHOUT BEING PROMPTED. DURING TESTING OUTSIDE OF THE BODY, THE OAD INTERMITTENTLY STARTED AND STOPPED SPINNING AND THE SALINE INFUSION PUMP WAS USED TO TROUBLESHOOT THE ISSUE. AFTER 2 TO 3 SECONDS THE OAD SPUN WITHOUT BEING PROMPTED AT 60,000 RPMS FOR APPROXIMATELY 2 TO 3 SECONDS BEFORE BECOMING CAUGHT ON STERILE TOWELS IN THE FIELD. THE DEVICE WAS REPLACED WITH A SECOND OAD TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAYS. THE PATIENT WAS DISCHARGED WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197898 ↗
• InjurySep 20, 2019Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  DURING A PROCEDURE WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE TIP BUSHING OF THE OAD FRACTURED. THE 10CM LONG, 85% STENOSED, HEAVILY CALCIFIED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR TIBIAL ARTERY, AND WAS ACCESSED VIA A FEMORAL APPROACH. THE LESION WAS LOCATED IN A STRAIGHT SEGMENT OF THE ARTERY THAT WAS 2MM IN DIAMETER. THE LESION WAS TREATED WITH FIVE TREATMENT PASSES ON LOW SPEED WITH THE OAD. AFTER THE FIFTH PASS, THE OAD LOST SPEED IN A TIGHT OCCLUSION. IT WAS OBSERVED THAT THE TIP BUSHING OF THE OAD WAS IN THE VESSEL. THE OAD WAS REMOVED FROM THE PATIENT, AND IT WAS CONFIRMED THAT THE TIP BUSHING HAD FRACTURED OFF AND REMAINED IN THE PATIENT. A NON-CSI CATHETER WAS USED TO ASPIRATE THE TIP BUSHING FROM THE VESSEL, AND NO PORTION OF THE OAD DRIVESHAFT WAS LEFT IN THE PATIENT. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED WITH STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE PATIENT WAS STABLE WITH NORMAL ARTERIAL FUNCTION FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9098254 ↗
• InjurySep 18, 2019Unexpected Shutdown; Unexpected Shutdown

  DURING A PROCEDURE, THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING AND A PERFORATION WAS NOTED AFTER REMOVAL OF THE OAD. THE OAD WAS OPERATED FOR ONE SECOND WHEN IT STOPPED SPINNING, AND WAS DIFFICULT TO REMOVE. ONCE THE OAD WAS REMOVED AN UNKNOWN MATERIAL WAS OBSERVED ON THE CROWN AND A PERFORATION WAS NOTED. BALLOON ANGIOPLASTY WAS PERFORMED IN ORDER TO ATTEMPT TO RESOLVE THE PERFORATION BUT THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Perforation of Vessels

  MAUDE report 9083080 ↗
• MalfunctionSep 12, 2019Unintended System Motion; Unintended System Motion

  DURING TREATMENT OF A 90% STENOSED LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE MOTOR STALLED AND THE DEVICE LOST POWER. THE OAD THEN STARTED OPERATING AGAIN INDEPENDENTLY. THE DEVICE WAS TURNED OFF BY THE PHYSICIAN AND REMOVED FROM THE PATIENT. THE DEVICE WAS UNPLUGGED AND RECONNECTED TO THE SALINE PUMP, HOWEVER THE ISSUE WAS UNABLE TO BE RESOLVED. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9010423 ↗
• InjuryAug 27, 2019Off-Label Use; Device Damaged by Another Device; Off-Label Use; Device Damaged by Another Device

  DURING A PROCEDURE WITH A CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), THE OAD WAS OPERATED IN A STENT AND THE STENT FRACTURED IN THE PATIENT. THE OAD WAS OPERATED IN THE PERONEAL ARTERY AND BALLOON ANGIOPLASTY WAS PERFORMED WITH NO ISSUES OBSERVED. THE BALLOON WAS RE-POSITIONED TOWARDS THE ARTERIAL TIBIAL ARTERY (AT) AND WAS UNABLE TO CROSS THE PROXIMAL SIDE OF THE AT. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE OAD WAS OPERATED FOR ONE TREATMENT UNTIL IT POWERED DOWN AND WAS REMOVED, AND IT WAS NOTED THAT IT HAD BEEN OPERATED IN A PREEXISTING STENT. THE STENT HAD FRACTURED INTO THREE FRAGMENTS. ATTEMPTS WITH BALLOON ANGIOPLASTY AND A NON-CSI SUPPORT CATHETER WERE MADE TO RETRIEVE THE STENT FRAGMENTS, BUT WERE UNSUCCESSFUL AND THE CASE WAS ABORTED. THE PATIENT WAS STABLE AND HAD BETTER FLOW POST PROCEDURE. IT IS PLANNED FOR THE PATIENT TO HAVE AN ADDITIONAL PROCEDURE. THE PHYSICIAN HAD PLACED THE STENT IN A PREVIOUS PROCEDURE, BUT DUE TO THE FACT THAT IT WAS A CORONARY STENT IN THE PERIPHERAL VASCULATURE, IT WAS NOT CLEARLY VISIBLE DURING IMAGING.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8935487 ↗
• MalfunctionAug 20, 2019Entrapment of Device; Entrapment of Device

  A PROCEDURE WAS ABORTED AFTER USE OF THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD). THE 100% STENOSED AND HEAVILY CALCIFIED TARGET LESION WAS LOCATED IN THE POSTERIOR TIBIAL ARTERY(PTA). THE LESION WAS BETWEEN 90MM AND 100MM IN LENGTH,WITH A REFERENCE VESSEL DIAMETER BETWEEN 2.0 AND 2.5MM. DURING REMOVAL OF THE OAD IT WAS OBSERVED TO BE ENGAGED WITH THE VIPERWIRE. AFTER 20 MINUTES OF TROUBLESHOOTING TO DISENGAGE THE OAD AND VIPERWIRE, THEY WERE REMOVED TOGETHER. THE VESSEL WAS UNABLE TO BE RE-WIRED DISTALLY TO PERFORM BALLOON ANGIOPLASTY AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8911076 ↗
• InjuryAug 2, 2019Entrapment of Device; Entrapment of Device

  THE CROWN OF THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL, DISTAL TO THE LESION. THE TARGET LESIONS WERE LOCATED IN THE ANTERIOR TIBIAL ARTERY (AT) AND THE DORSALIS PEDIS ARTERY (DP). THE LESIONS WERE HEAVILY CALCIFIED, WITH 99% STENOSIS AND A VESSEL DIAMETER OF 2.0MM. PRIOR TO TREATMENT WITH THE OAD THERE WAS MINIMAL BLOOD FLOW IN THE DISTAL AT AND DP, AND THERE WAS NO FLOW NOTED IN THE PEDAL ARCH; THESE FLOW ISSUES WERE DUE TO THE PATIENT'S DISEASE STATE AND ANATOMY. THE OAD WAS OPERATED FOR TWO TREATMENTS ON LOW SPEED WHEN IT BECAME STUCK DISTAL TO THE LESION, JUST PAST THE PEDAL ARCH. MULTIPLE ATTEMPTS WITH A BUDDY WIRE AND BALLOON ANGIOPLASTY WERE MADE TO REMOVE THE OAD, AFTER WHICH THE OAD WAS CUT. SEVERAL MORE ATTEMPTS WERE MADE WITH THE BUDDY WIRE, A CATHETER AND BALLOON ANGIOPLASTY WERE MADE TO LOOSEN THE CROWN, BUT THEY WERE UNSUCCESSFUL. ADDITIONAL FORCE WAS USED TO ATTEMPT TO REMOVE THE CROWN, BUT THE CROWN FRACTURED OFF AND REMAINED STUCK IN THE VESSEL. THE CROWN WAS UNABLE TO BE RETRIEVED AND REMAINED IN THE PATIENT. THIS EVENT CAUSED A 45-MINUTE DELAY. THE PREEXISTING BLOOD FLOW ISSUE WAS RESOLVED DURING THE PROCEDURE, AND TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854985 ↗
• InjuryJul 23, 2019Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A HEAVILY CALCIFIED, 100% OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY (AT) THAT WAS APPROXIMATELY EIGHT (8) CM IN LENGTH. THE VESSEL WAS APPROXIMATELY 2.5 TO 3 MM IN DIAMETER AND WAS NOT TORTUOUS. THE LESION WAS CROSSED VIA TIBIOPEDAL ACCESS AND THE OAD WAS USED VIA A FEMORAL ACCESS. THE LESION WAS TREATED WITH FOUR (4) TREATMENT PASSES WITH THE OAD. WHEN ATTEMPTING TO REMOVE THE OAD, THE CROWN BECAME STUCK AT THE OSTIUM OF THE AT. ATTEMPTS WERE MADE WITH BALLOON ANGIOPLASTY TO FREE THE CROWN, HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. A CATHETER WAS INSERTED VIA THE TIBIOPEDAL ACCESS POINT AND PASSED OVER THE OAD CROWN, AND THE OAD WAS THEN ABLE TO BE REMOVED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH PERCUTANEOUS BALLOON ANGIOPLASTY, AND NO STENT WAS REQUIRED AT THE LOCATION THE OAD CROWN HAD BECOME STUCK. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE, AND FLOW HAD BEEN ESTABLISHED THROUGH THE ANTERIOR TIBIAL ARTERY. IT WAS NOTED THAT THE PATIENT WOULD HAVE ADDITIONAL REVASCULARIZATION IN THE FUTURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8818193 ↗
• InjuryJul 12, 2019Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED THROUGH A THREE MONTH OLD STENT STRUT LOCATED IN THE TIBIAL PERONEAL TRUNK BEFORE TREATING A HEAVILY CALCIFIED, 90% STENOSED LESION IN THE POSTERIOR TIBIAL ARTERY (PT). DURING REMOVAL OF THE OAD FOLLOWING TREATMENT, THE DEVICE BECAME STUCK IN THE STENT STRUTS. THE BRAIDED CATHETER WAS CUT AND THE OAD SHEATH WAS CUT AND REMOVED. ANOTHER CATHETER WAS INSERTED TO AID IN CROWN REMOVAL, AND ALTHOUGH IT WOULD NOT ADVANCE TO THE STENT STRUTS IT PROVIDED SUFFICIENT SUPPORT TO FACILITATE REMOVAL OF THE CROWN. WHEN THE CROWN WAS REMOVED THE STENT STRUTS PULLED BACK AND FORMED A BALL, REMAINING IN THE VESSEL BELOW ANOTHER PREVIOUS, UNDAMAGED STENT. THIS CAUSED A LOSS OF BLOOD FLOW. WIRE POSITION WAS LOST AS THE CROWN WAS REMOVED AND WAS UNABLE TO BE REGAINED THROUGH ANTEGRADE OR RETROGRADE APPROACHES, THEREFORE THE PROCEDURE WAS ABORTED AND NO ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE, AND ADDITIONAL SURGICAL INTERVENTION WAS BEING CONSIDERED.

  Patient problems: Vascular System (Circulation), Impaired

  MAUDE report 8784684 ↗
• MalfunctionJul 11, 2019Entrapment of Device; Malposition of Device; Entrapment of Device; Malposition of Device

  DURING TREATMENT OF A 100% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS NOTED TO AUDIBLY CHANGE PITCH. WHEN THE TREATMENT RESULTS WITH THE OAD WERE DEEMED SATISFACTORY, THE OAD WAS RETRACTED BUT WAS STUCK ON THE VIPERWIRE GUIDE WIRE AND WAS UNABLE TO BE REMOVED WITHOUT ALSO MOVING THE WIRE OUT OF POSITION. THE OAD AND WIRE WERE REMOVED TOGETHER. UPON REMOVAL, TISSUE WAS NOTED ON THE CROWN OF THE OAD. THE PHYSICIAN WAS UNABLE TO REWIRE THE VESSEL SUCCESSFULLY IN THE TRUE LUMEN, AND THE PROCEDURE WAS DELAYED BY THIRTY MINUTES. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE, HOWEVER THE BALLOON WAS ONLY ABLE TO ADVANCE A PARTIAL DISTANCE THROUGH THE VESSEL. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS DISCHARGED FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781574 ↗
• InjuryJun 27, 2019Entrapment of Device; Unexpected Shutdown; Entrapment of Device; Unexpected Shutdown

  DURING TREATMENT OF A 80% STENOSED LESION IN THE ANTERIOR TIBIAL ARTERY WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), ONE PASS WAS PERFORMED ON LOW SPEED AND TWO ON MEDIUM SPEED. WHEN HIGH SPEED WAS SELECTED, THE OAD LOST SPEED WHEN ENGAGING THE DISTAL LESIONS, BUT WAS ABLE TO PASS THROUGH. WHEN THE OAD WAS MOVED PROXIMAL, THE DEVICE SHUT DOWN AND BECAME STUCK ON THE GUIDE WIRE DUE TO POSSIBLE VESSEL SPASM. THE CROWN WAS ABLE TO BE REMOVED FROM THE GUIDE WIRE AND NAVIGATED TO THE SUPERFICIAL FEMORAL ARTERY, HOWEVER IT WOULD NOT SPIN. THE SYSTEM WAS RESTARTED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. FOLLOWING REMOVAL OF THE OAD, NO FLOW WAS PRESENT IN THE VESSEL. NITROGLYCERIN WAS ADMINISTERED AND BALLOON ANGIOPLASTY WAS PERFORMED, FOLLOWING WHICH THE VESSEL WAS OPEN AND PATENT. FOLLOWING BALLOON ANGIOPLASTY, A TYPE B DISSECTION WAS NOTED WHICH WAS RELATED TO MULTIPLE BALLOON INFLATIONS. THE DISSECTION WAS RESOLVED BY INFLATING ANOTHER BALLOON AT THE SITE FOR TWO MINUTES. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available; Vascular System (Circulation), Impaired

  MAUDE report 8741271 ↗
• MalfunctionJun 20, 2019Infusion or Flow Problem; Infusion or Flow Problem

  DIFFICULTY WAS ENCOUNTERED DURING ATTEMPTED FLUSHING OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). RESISTANCE WAS ENCOUNTERED DURING ATTEMPTS TO FLUSH AIR FROM THE SALINE TUBING. DESPITE TROUBLESHOOTING, AIR COULD NOT BE PURGED FROM THE TUBING, AND A SECOND OAD WAS USED TO SUCCESSFULLY CONTINUE THE PROCEDURE. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8718285 ↗
• MalfunctionJun 4, 2019Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE BECAME STUCK IN A LESION IN THE POPLITEAL ARTERY. THE LESION WAS HIGHLY CALCIFIED AND THE VESSEL WAS 90-99% STENOTIC. TROUBLESHOOTING ATTEMPTS WERE MADE FOR OVER 30 MINUTES, AND THE DEVICE WAS EVENTUALLY REMOVED WITH USE OF AN ANGIOPLASTY BALLOON. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8666551 ↗
• MalfunctionJun 3, 2019Infusion or Flow Problem; Infusion or Flow Problem

  WHEN THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED OVER THE GUIDE WIRE, THE DEVICE WOULD NOT FLUSH. TROUBLESHOOTING WAS PERFORMED, HOWEVER THE ISSUE WAS UNABLE TO BE RESOLVED. THE DEVICE WAS NOT OBSERVED TO BE LEAKING. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663989 ↗
• InjuryMay 28, 2019Entrapment of Device; Entrapment of Device

  DURING TREATMENT OF THE DORSALIS PEDIS ARTERY (DP) WITH A CSI DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE STALLED AND THE CROWN BECAME STUCK IN THE VESSEL. NITROGLYCERIN WAS ADMINISTERED AND A BUDDY WIRE WAS ADVANCED. THE DRIVESHAFT WAS PULLED GENTLY, HOWEVER THE CROWN WOULD NOT DISLODGE. THE SALINE SHEATH OF THE OAD WAS CUT AND ADVANCED OVER THE DRIVESHAFT, BUT WAS UNABLE TO ADVANCE TO THE CROWN. THE DRIVESHAFT OF THE OAD WAS CUT, THE LESION WAS RE-WIRED WITH A VIPERWIRE GUIDE WIRE, AND A MULTIPURPOSE CATHETER WAS ADVANCED OVER THE DRIVESHAFT BUT WAS TOO SHORT TO REACH THE CROWN. NITROGLYCERIN WAS ADMINISTERED AGAIN, AND A BALLOON WAS INSERTED AND INFLATED. A VIPERCATH EXCHANGE CATHETER WAS ADVANCED OVER THE DRIVESHAFT, BUT WOULD NOT ADVANCE INTO THE DP. A SNARE WAS INTRODUCED OVER THE BUDDY WIRE, HOWEVER THE SNARE LOOP BROKE AND IT WOULD NOT ADVANCE TO THE DP. AN ATTEMPT WAS MADE TO GAIN ACCESS TO THE POSTERIOR TIBIAL ARTERY, BUT WAS NOT SUCCESSFUL. A NON-CSI CATHETER WAS ADVANCED OVER THE DRIVESHAFT AND WAS ABLE TO DISLODGE THE CROWN. FOLLOWING REMOVAL OF THE DEVICE, VASOPSASM PREVENTED PEDAL LOOP RE-ENTRY AND THROMBUS WAS NOTED THROUGHOUT THE VESSEL. THE

  Patient problems: No Code Available; Thrombus; Vessel Or Plaque, Device Embedded In

  MAUDE report 8646216 ↗
• InjuryMay 14, 2019Entrapment of Device; Entrapment of Device

  TREATMENT OF A LESION IN THE SUPERIOR FEMORAL ARTERY (SFA) WITH A 2.0MM DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) VIA CONTRALATERAL FEMORAL APPROACH WAS SUCCESSFUL. THE VIPERWIRE WAS EXCHANGED FOR A WORKHORSE WIRE, WHICH WAS USED TO GAIN ACCESS IN THE AT. THE WORKHORSE WIRE WAS THEN EXCHANGED FOR THE VIPERWIRE. A 1.25MM OAD WAS USED FOR FURTHER TREATMENT, BUT BECAME STUCK AFTER ABOUT 4CM OF THE LESION WAS TREATED. THE SALINE SHEATH OF THE OAD WAS USED IN ATTEMPT TO FREE THE CROWN, BUT THE ATTEMPT WAS NOT SUCCESSFUL. MULTIPLE OTHER TROUBLESHOOTING ATTEMPTS WERE UNSUCCESSFUL IN FREEING THE OAD, AND THE PROCEDURE WAS DELAYED BY MORE THAN AN HOUR. THE DEVICE WAS REMOVED SURGICALLY, AND UNOBSTRUCTED FLOW TO THE AFFECTED AREA WAS NOTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 8607326 ↗
• InjuryMay 3, 2019Entrapment of Device; Entrapment of Device

  DURING A PROCEDURE FOR A PATIENT WITH CRITICAL LIMB ISCHEMIA, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT DIFFUSE LESIONS. THE PATIENT HAD DIFFUSELY DISEASED LESIONS THROUGHOUT THE POSTERIOR TIBIAL ARTERY (PT), ANTERIOR TIBIAL ARTERY (AT), AND PEDAL LOOP ARTERIES. THE CALCIFICATION OF THE LESIONS WERE MODERATE TO SEVERE WITH 75-95% STENOSIS DEPENDING ON THE AREA. THE PT WAS TREATED WITH NON-CSI DIRECTIONAL ATHERECTOMY, AND THEN THE ENTIRE DISEASED AREA WAS WIRED. ORBITAL ATHERECTOMY WITH THE CSI OAD WAS USED IN THE PT, AND ON THE THIRD TREATMENT PASS, THE CROWN OF THE OAD BECAME STUCK IN A LESION IN THE PLANTAR VESSEL DISTAL TO THE TREATMENT AREA AND STOPPED SPINNING. IT WAS NOTED THAT THERE WAS QUITE A BIT OF VESSEL SPASMS OCCURRING DURING THE PROCEDURE. THE DRIVESHAFT AND SALINE SHEATH OF THE OAD WERE CUT, AND A NON-CSI CATHETER WAS USED TO REMOVE THE OAD FROM THE VESSEL. AFTER THE OAD WAS REMOVED, ANGIOGRAPHIC IMAGING WAS PERFORMED AND A LARGE DISSECTION WAS OBSERVED AFFECTING A LONG SECTION OF THE LATERAL PLANTAR ARTERY. IT WAS UNKNOWN IF THE DISSECTION OCCURRED BEFORE OR AFTER THE REMOVAL OF THE OAD. NO ADDITIONAL INTERVENTION WAS PERFORMED RE

  Patient problems: No Code Available; Vascular Dissection; Vessel Or Plaque, Device Embedded In

  MAUDE report 8579085 ↗
• MalfunctionApr 22, 2019Failure to Advance; Failure to Advance

  DURING A PROCEDURE THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WOULD NOT ADVANCE PAST THE MID-SUPERFICIAL FEMORAL ARTERY (SFA). A KINK WAS OBSERVED ON THE VIPERWIRE, ALTHOUGH THE KINK WAS NOT WITHIN THE OAD AND WAS EX VIVO AT THE TIME THAT THE ADVANCEMENT DIFFICULTY WAS ENCOUNTERED. THE VIPERWIRE WAS EXCHANGED FOR A SECOND VIPERWIRE, BUT AGAIN THE OAD WOULD NOT ADVANCE PAST THE SFA. THE OAD WAS REMOVED. OVER-THE-WIRE BALLOONS WERE USED TO CONTINUE THE PROCEDURE BUT ALSO WOULD NOT ADVANCE PAST THE SFA. THE PROCEDURE WAS COMPLETED USING A DIFFERENT GUIDEWIRE AND BALLOON ANGIOPLASTY. THE PROCEDURE WAS DELAYED BY GREATER THAN 30 MINUTES, AND THE DELAY WAS ATTRIBUTED TO THE OAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535773 ↗
• InjuryApr 2, 2019Entrapment of Device; Material Separation; Unintended Movement; Entrapment of Device; Material Separation; Unintended Movement

  A MODERATELY CALCIFIED, 95% STENOSED LESION WAS LOCATED IN MILDLY TORTUOUS AREA OF THE POSTERIOR TIBIAL (PT) ARTERY BEYOND THE LEVEL OF THE ANKLE. THE LESION WAS 3.5 CM IN LENGTH AND THE VESSEL WAS 1.5-2 MM. THE VIPERWIRE GUIDE WIRE WAS ADVANCED PAST THE HEEL AND APPEARED TO BE LOCATED IN A LUMINAL PLANE. THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED 2-3 MM PROXIMAL TO THE LESION. THE OAD WAS TURNED ON AT LOW SPEED, AND THE CROWN JUMPED FORWARD ON THE GUIDE WIRE AND STOPPED SPINNING. AN ATTEMPT WAS MADE TO REMOVE THE OAD FROM THE GUIDE WIRE; HOWEVER, THE DEVICES WERE STUCK TOGETHER AND UNABLE TO BE REMOVED USING CONSIDERABLE FORCE. A NON-CSI GUIDE WIRE WAS ADVANCED IN AN ATTEMPT TO LOOSEN THE CROWN FROM THE VESSEL WALL, BUT THIS WAS UNSUCCESSFUL. A CORONARY BALLOON WAS USED TO ATTEMPT TO CREATED SPACE IN THE REMOVAL OF THE DEVICE, BUT THE DEVICE REMAINED STUCK. THE SALINE SHEATH OF THE OAD DRIVESHAFT WAS CUT AT THE STRAIN RELIEF OF THE OAD. THE SALINE SHEATH WAS ADVANCED OVER THE CROWN OF THE OAD, AND THE OAD AND GUIDE WIRE WERE SUCCESSFULLY REMOVED. IT WAS OBSERVED AFTER THE DEVICES WERE REMOVED THAT A PORTION APPROXIMATELY 7 CM OF THE SPRING TIP OF THE

  Patient problems: Foreign Body In Patient; Vascular System (Circulation), Impaired

  MAUDE report 8472956 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), A PATIENT ISSUE OCCURRED. MULTIPLE LESIONS WERE PRESENT IN THE ANTERIOR TIBIAL ARTERY (AT) AND WERE 80-90% STENOSED. THREE SECTIONS OF THE AT WERE TREATED WITH THE OAD ON LOW, MEDIUM AND HIGH SPEEDS. THE OAD WAS REMOVED AND ANGIOGRAPHY DEMONSTRATED GOOD BLOOD FLOW DOWN THE RIGHT AT. THE PATIENT PRESENTED WITH DISCOMFORT AND IT WAS FOUND THAT THE PATIENT IV HAD INFILTRATED AND THE PATIENT HAD NOT BEEN RECEIVING SEDATIVE OR HEPARIN. NO FLOW WAS OBSERVED AND IMAGING SHOWED THE PRESENCE OF THROMBUS IN THE POPLITEAL PROXIMAL TO THE LESIONS. AN ATTEMPT WAS MADE TO ASPIRATE THE SHEATH BUT WAS UNSUCCESSFUL. THROMBOLYTIC THERAPY AND HEPARIN WERE ADMINISTERED AND BALLOON ANGIOPLASTY WAS PERFORMED DOWN THE DISTAL VESSEL TO RESOLVE THE THROMBUS AND RESTORE FLOW.

  Patient problems: Discomfort; Thrombus

  MAUDE report 8464532 ↗