Diamondback Peripheral DBP-125SOLID145 (REF 7-10057-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10850000491189), received between May 22, 2020 and Mar 24, 2026 — classified as 22 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (10 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Difficult to Remove; Unexpected Shutdown

  IT WAS REPORTED THAT THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED FOR TREATMENT OF THE LEFT PERONEAL ARTERY (PT) THROUGH COMMON FEMORAL ARTERY (CFA) ACCESS. WHILE SPINNING, THE OAD MADE AN AUDIBLE SOUND (BOGGED DOWN) AND COULD NOT BE RETRACTED OVER THE VIPERWIRE ADVANCE GUIDE WIRE; IT SEEMED THE OAD/CROWN WAS STUCK ON THE VIPERWIRE. IT WAS UNKNOWN IF THE OAD LED LIGHTS WERE LIT WHEN THE OAD STALLED. EVERYTHING HAD TO BE PULLED OUT. EX VIVO THERE WAS NO PHYSICAL DAMAGE OBSERVED ON THE OAD DRIVESHAFT OR VIPERWIRE. THE PHYSICIAN ATTEMPTED TO REWIRE THE PERONEAL ARTERY TO TREAT THE DISSECTION UNSUCCESSFULLY - THE LESION WAS IN ANTERIOR TIBIAL ARTERY. THERE WAS NO FLOW WHEN AN IMAGE WAS OBTAINED IN PERONEAL ARTERY WHEN THE OAD AND VIPERWIRE WERE REMOVED. DURING FINAL ANGIOGRAM, SOME FLOW WAS NOTED IN PERONEAL ARTERY BUT WAS NOT COMPLETE TO THE FOOT. THE PROCEDURE WAS COMPLETED WITH INTRAVASCULAR LITHOTRIPSY (IVL) AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT WAS STABLE. IT WAS BELIEVED THE OAD STALLED IN A DISSECTION AREA IN PERONEAL ARTERY, HOWEVER, THIS WAS NOT CONFIRMED.

  Patient problems: Obstruction/Occlusion; Vascular Dissection

  MAUDE report 24682245 ↗
• MalfunctionMar 2, 2026Difficult to Remove

  IT WAS REPORTED THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DID NOT FUNCTION PROPERLY AND GOT STUCK ON THE VIPERWIRE GUIDE WIRE DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484935 ↗
• InjuryNov 4, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) CROWN GOT STUCK. A CUTDOWN OF THE OAD WAS PERFORMED WITH A SHEATH AND CATHETER BEING INSERTED IN AN ATTEMPT TO RETRIEVE THE STUCK DEVICE, HOWEVER, THIS WAS UNSUCCESSFUL. EVENTUALLY A VASCULAR SURGEON RECOMMENDED TO PULL EXTREMELY HARD ON THE DEVICE WHICH ENDED UP RESOLVING THE ISSUE. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23467088 ↗
• MalfunctionOct 23, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING PERIPHERAL INTERVENTION OF THE LEFT LEG VIA RIGHT FEMORAL ARTERY & LEFT POSTERIOR TIBIAL (PT) PEDAL ACCESS, A VIPERWIRE PERIPHERAL GUIDEWIRE WAS ADVANCED DOWN INTO THE DISTAL PERONEAL ARTERY. THE 1.25 SOLID DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PLACED OVER THE VIPERWIRE GUIDEWIRE TO TREAT THE TIBIOPERONEAL (TP) TRUNK AND DOWN TO ABOUT THE MID-PERONEAL. AT SOME POINT BETWEEN CHECKING THE VIPERWIRE GUIDEWIRE TIP PLACEMENT AND THEN ACTUALLY STARTING THE TREATMENT, THE GUIDEWIRE WAS PULLED BACK AND THEN ADVANCED DEEP INTO A COLLATERAL. DURING FIRST TREATMENT, A SLACK IN THE VIPERWIRE GUIDEWIRE WAS NOTICED ON THE FLOUROSCOPY MONITOR. THE GUIDEWIRE FRACTURED AND THE OAD AUTOMATICALLY SHUT OFF. THE OAD WAS REMOVED, TWO GUIDEWIRE FRAGMENTS LEFT IN-VIVO. THE MAJORITY OF THE TIP OF THE VIPERWIRE GUIDEWIRE SPRING TIP WAS LODGED DEEP INTO A COLLATERAL OFF OF THE PERONEAL. A SMALL PIECE OF WIRE FRAGMENT WAS AT THE DISTAL TO THE TAKEOFF OF THE PERONEAL. MULTIPLE SNARES WERE USED TO TRY AND REMOVE THE FRAGMENTS BUT WERE UNSUCCESSFUL. AT THIS POINT IT WAS NOTICED THAT THE SMALL PROXIMAL FRAGMENT PIECE WAS MOSTLY OCCLUSIVE AND THERE WAS NO FLOW IN E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369859 ↗
• InjurySep 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER THE USE OF DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), DURING REMOVAL OF THE OAD OVER VIPERWIRE GUIDEWIRE, THE GUIDEWIRE BECAME STUCK IN THE DEVICE. THE OAD AND GUIDEWIRE WERE REMOVED TOGETHER, CAUSING A DELAY IN THE PROCEDURE DUE TO THE PHYSICIAN NEEDING TO ATTEMPT TO CROSS THE LESION AGAIN WITH A NEW WIRE, WHICH WAS UNSUCCESSFUL. DUE TO NOT BEING ABLE TO RE-CROSS THE LESION, THE PROCEDURE WAS ABORTED WITHOUT FULLY TREATING THE PATIENT. IT IS UNKNOWN HOW MANY TREATMENTS WERE PERFORMED PRIOR TO OAD REMOVAL. ACCORDING TO THE PHYSICIAN, THE DELAY IN PROCEDURE WAS CONSIDERED TO BE CLINICALLY SIGNIFICANT TO THE PATIENT DUE TO THE GUIDEWIRE BEING REMOVED AND THE INABILITY TO CROSS THE LESION AGAIN WITH ANOTHER WIRE AS THIS LED TO THE PROCEDURE NOT BEING COMPLETED, LEAVING A SIGNIFICANT BLOCKAGE. IN THE OPINION OF THE PHYSICIAN, THE ABORTED PROCEDURE CONSIDERED TO BE CLINICALLY SIGNIFICANT TO THE PATIENT AS THE BLOCKAGE WAS NOT FULLY TREATED RESULTING IN NEED FOR A SECOND PROCEDURE ON THE PATIENT THAT WOULD NOT HAVE BEEN NECESSARY HAD THE WIRE NOT BEEN REMOVED. THE PATIENT HAS A FOLLOW-UP PROCEDURE PLANNED AND WAS STABLE. ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031027 ↗
• InjuryMay 2, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE 1.25 MICRO SOLID DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR PROXIMAL-TO-DISTAL TREATMENT OF LESION IN TIBIAL ARTERY THROUGH FEMORAL ARTERY ACCESS. FOLLOWING THE FIRST TREATMENT, ANGIOGRAPHIC IMAGES SHOWED A PARTICLE SEPARATED FROM THE OAD CROWN. UPON OAD REMOVAL, THE CROWN WAS OBSERVED DETACHED. THE FRAGMENT SIZE WAS UNKNOWN. IT WAS UNKNOWN IF THE DRIVESHAFT FRACTURED. THE FRAGMENT WAS LEFT IN ONE OF THE TIBIAL VESSELS AS THERE WAS FLOW TO OTHER VESSELS. NO ATTEMPTS TO SNARE THE FRAGMENT WAS MADE. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AND DISCHARGED THE SAME DAY. THERE WERE NO FUTURE PLANS TO REMOVE THE FRAGMENT.

  Patient problems: Embolism/Embolus; Foreign Body In Patient

  MAUDE report 21950634 ↗
• InjuryFeb 7, 2025Improper or Incorrect Procedure or Method; Noise, Audible; Unexpected Shutdown; Improper or Incorrect Procedure or Method; Noise, Audible; Unexpected Shutdown

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN ANTERIOR TIBIAL ARTERY (AT) VIA PEDAL ACCESS. DURING THE FIRST TREATMENT, LOW SPEED WAS USED BUT AN AUDIBLE PITCH CHANGE WAS HEARD FROM NORMAL GRINDING TO THE OAD CROWN SEEMINGLY GETTING STUCK WHICH CAUSED IT TO DECELERATE SO IT WAS TURNED OFF TO STOP THE CROWN FROM SPINNING. THE OAD LED LIGHTS REMAINED LIT. THE OAD WAS REMOVED. THERE WAS NO OAD DAMAGE OR TISSUE OBSERVED ON THE CROWN UPON REMOVAL. THE .014 VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE WITH FLEX TIP REMAINED IN PLACE. ANGIOGRAPHIC IMAGES SHOWED PERFORATION IN AT. IN THE OPINION OF THE PHYSICIAN THE OAD CAUSED THE PERFORATION DUE TO THE VIPERWIRE GOING SUBINTIMAL WITHOUT HIM REALIZING IT. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION. TO RESOLVE THE PERFORATION, A JADE BALLOON WAS INFLATED IN THE LESION FOR FIVE MINUTES. THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND DISCHARGED THE SAME DAY TO BE BROUGHT BACK IN SIX WEEKS TO CONTINUE TREATMENT.

  Patient problems: Perforation of Vessels

  MAUDE report 21335308 ↗
• InjuryJul 3, 2024Off-Label Use; Difficult to Remove; Material Separation; Unexpected Shutdown; Off-Label Use; Difficult to Remove; Material Separation; Unexpected Shutdown

  DURING RIGHT PERIPHERAL ANGIOGRAM PROCEDURE TO TREAT A RIGHT TOE ULCER, A 90CM 6F NON-CI/ABBOTT SHEATH WAS PLACED VIA A NON-CSI/ABBOTT GUIDEWIRE. A NON-CSI/ABBOTT CATHETER WAS USED TO CROSS THE LESIONS AND AN ABBOTT COMMAND WIRE WAS SWITCHED OUT FOR THE VIPERWIRE ADVANCE GUIDEWIRE VIA THE NON-CSI/ABBOTT CATHETER. THE NON-CSI/ABBOTT CATHETER WAS REMOVED, AND A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS INSERTED OVER THE VIPERWIRE ADVANCE GUIDEWIRE. THE OAD WAS SPUN ON LOW SPEED FOR 30 SECONDS, MEDIUM SPEED FOR 30 SECONDS AND HIGH SPEED FOR 10 SECONDS BEFORE A SNAGGING NOISE WAS HEARD AND THE OAD SHUT OFF. THE PHYSICIAN ATTEMPTED TO REMOVE THE OAD LEAVING THE WIRE, BUT THE GUIDEWIRE WAS STUCK AND WAS REMOVED ALONG WITH THE OAD. IT WAS THEN NOTICED THAT THE SPRING TIP OF THE GUIDEWIRE WAS BROKEN AND WAS LODGED SOMEWHERE IN THE DISTAL ANTERIOR TIBIAL (AT) ARTERY. THE OAD AND THE GUIDEWIRE WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. UPON INSPECTION, IT APPEARED THAT A STENT WAS WRAPPED AROUND THE DRIVESHAFT OF THE OAD. EARLIER IMAGES OF THE OAD DID NOT SHOW AN OBVIOUS STENT IN THE AT, HOWEVER THE VESSELS WERE VERY CALCIFIED AND THERE WAS SOME MOVEMENT IN THE PREV

  Patient problems: Foreign Body In Patient; Reduced Blood Flow

  MAUDE report 19667709 ↗
• InjuryMar 29, 2024Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK SUB INTIMAL IN A MODERATELY CALCIFIED MID ANTERIOR TIBIAL ARTERY (AT). THE PHYSICIAN ATTEMPTED TO INFLATE A BALLOON TO FREE THE OAD, HOWEVER, THIS WAS UNSUCCESSFUL. THE OAD SHEATH WAS CUT, WHILE KEEPING THE VIPERWIRE ADVANCE GUIDE WIRE IN PLACE TO ADVANCE A GUIDE CATHETER TO INCAPSULATE THE OAD AND REMOVE FROM THE VESSEL. THE OAD WAS RETRIEVED, WITH THE CROWN REMAINING IN THE SHEATH. THE PROCEDURE WAS COMPLETED AFTER REMOVAL OF THE OAD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19004002 ↗
• MalfunctionMar 13, 2024Entrapment of Device; Entrapment of Device

  DURING TREATMENT OF A HEAVILY CALCIFIED LONG LESION IN THE ANTERIOR TIBIAL ARTERY, THE CROWN OF THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE VESSEL AND STALLED. THE CROWN AND THE CONTROL KNOB DID NOT MOVE ONE TO ONE AND THE CONTROL KNOB ONLY MOVED AND JUMPED BACK. 8-10 SHORT TREATMENTS WERE PERFORMED IN THREE REGIONS OF THE ANTERIOR LESION WITH A COMBINATION OF LOW AND MEDIUM SPEED PER TREATMENT. NITROGLYCERIN WAS ADMINISTERED TO THE PATIENT AND TROUBLESHOOTING WAS DONE BY BOTH LOCKING AND UNLOCKING THE CROWN ADVANCER KNOB WITH A REPRESENTATIVE'S ASSISTANCE VIA PHONE. THE OAD WAS REMOVED FROM THE PATIENT'S BODY AND UPON REMOVAL, THE OAD APPEARED FINE WITH NO DAMAGE. ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE ISSUE WAS LIKELY DUE TO SEVERE CALCIUM BUILDUP AND A PROLONGED TIME OF TREATMENT DUE TO THE DISEASE SEVERITY. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18896304 ↗
• InjuryJan 26, 2024Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT AND BECAME STUCK IN THE PEDAL ARCH VESSEL. NITROGLYCERIN AND HEPARIN WERE ADMINISTERED, AND ANGIOPLASTY WAS PERFORMED TO SUCCESSFULLY FREE THE OAD. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18588589 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT LESIONS IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND A CHRONIC TOTAL OCCLUSION (CTO) IN THE POPLITEAL ARTERY. THE OAD STOPPED THREE TIMES DURING TREATMENT. THE OAD WAS REMOVED, AND WIRE ACCESS WAS LOST DUE TO THE PATIENT MOVING THROUGHOUT THE PROCEDURE. EX-VIVO THERE WAS NO DAMAGE OBSERVED TO THE VIPERWIRE. IMAGING SHOWED A DISSECTION WITH NO FLOW PAST THE POPLITEAL. THE PHYSICIAN RE-WIRED AND USED SHOCKWAVE, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY, AND STENTS TO ACHIEVE FLOW SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 16436278 ↗
• InjuryAug 24, 2022Mechanical Jam; Mechanical Jam

  TREATMENT WAS BEING PERFORMED USING A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN A LONG, DIFFUSELY DISEASED VESSEL BELOW THE KNEE (BTK). THE LESION IN THE ARTERY BTK WAS TIGHT. WHEN ATTEMPTING TO REMOVE THE OAD, IT BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE. THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER. WIRE PLACEMENT WAS LOST, WHICH RESULTED IN THE PATIENT RECEIVING ADDITIONAL CONTRAST AND RADIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15286037 ↗
• InjuryJun 7, 2022Entrapment of Device; Material Frayed; Material Integrity Problem; Entrapment of Device; Material Frayed; Material Integrity Problem

  USING THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), ATHERECTOMY TREATMENT IN THE DISTAL PERINEAL WHICH WAS MODERATELY CALCIFIED WAS PERFORMED PROXIMAL TO DISTAL. LOW, MEDIUM AND HIGH SPEED WERE USED AND WHILE USING HIGH SPEED THE CROWN BECAME ENTRAPPED IN THE VESSEL. THE OAD WAS NOT ABLE TO BE ADVANCED PROXIMALLY OUT OF THE VESSEL. USING THE ADVANCER KNOB, UNSUCCESSFUL ATTEMPTS WERE MADE TO REMOVE THE DEVICE. THE PHYSICIAN MANUALLY PULLED ON THE DRIVESHAFT, CAUSING IT TO FRAY. THE PHYSICIAN THEN CUT THE DRIVESHAFT AND REMOVED THE OAD. THE PORTION OF THE DRIVESHAFT THAT WAS CUT, INCLUDING THE CROWN, REMAINED IN THE POPLITEAL CAUSING AN ARTERIOVENOUS FISTULA. THE PROCEDURE LASTED APPROXIMATELY SEVEN HOURS WHILE ATTEMPTING TO REMOVE THE CROWN. THE PATIENT UNDERWENT AMPUTATION.

  Patient problems: Fistula; Foreign Body In Patient

  MAUDE report 14626557 ↗
• InjuryMay 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A LESION IN THE ANTERIOR TIBIAL ARTERY. A SEVERE DISSECTION OCCURRED, AND THE OAD WAS REMOVED. TISSUE WAS OBSERVED ON THE OAD CROWN. A STENT WAS DEPLOYED TO TREAT THE DISSECTION, AND AN ARTERIOVENOUS FISTULA OCCURRED. THE PATIENT WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: Fistula; Vascular Dissection

  MAUDE report 14538811 ↗
• InjuryMar 28, 2022Adverse 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 USE VIA GROIN ACCESS FOR TREATMENT IN THE POSTERIOR TIBIAL (PT) AND LATERAL PLANTAR ARTERIES. THERE WAS MODERATE TORTUOSITY IN THE LATERAL PLANTAR ARTERY. THE VESSEL WAS 2.5MM IN DIAMETER AND 95% STENOSED WITH SEVERE CALCIFICATION. A RECOMMENDATION WAS MADE TO THE PHYSICIAN TO USE A SMALLER CROWN AND TO NOT ADVANCE THE OAD INTO THE LATERAL PLANTAR ARTERY, BUT THE SUGGESTION WAS NOT FOLLOWED. THE PT AND LATERAL PLANTAR WERE TREATED WITH LOW AND MEDIUM SPEEDS. A HIGH-SPEED TREATMENT WAS THEN PERFORMED IN THE PT. TREATMENTS WERE 25 SECONDS. MULTIPLE ATTEMPTS AT ANGIOPLASTY WERE MADE. THEREAFTER, THERE WAS NO FLOW DISTAL TO THE PEDAL ARCH. ANGIOPLASTY WAS APPLIED, AND AN ATTEMPT WAS MADE TO TREAT FROM THE ANTERIOR TIBIAL ARTERY THROUGH THE DORSALIS PEDIS IN ORDER TO ESTABLISH FLOW IN THE ARCH. NITROGLYCERIN WAS ALSO ADMINISTERED. IN THE OPINION OF THE PHYSICIAN, THE SPECIFIC CAUSE OF NO FLOW WAS SPASM AND PARTICULATE FROM OA. AS OF (B)(6) 2022, STRONG OUTFLOW HAD NOT BEEN REESTABLISHED. THE PATIENT UNDERWENT AN ADDITIONAL ANGIOGRAM AN ALTEPLASE INFUSION.

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

  MAUDE report 13932489 ↗
• MalfunctionFeb 1, 2022Material Separation; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA LEFT FEMORAL ACCESS AND CONTRALATERAL APPROACH FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL DIAMETER WAS THOUGHT TO BE 6.0MM. CALCIUM WAS SEVERE. ONE TREATMENT WAS PERFORMED ON LOW SPEED, AND ONE TREATMENT PASS WAS PERFORMED ON MEDIUM SPEED. BOTH TREATMENTS WERE PERFORMED DISTAL TO PROXIMAL. THESE TREATMENTS WERE PERFORMED IN THE PROXIMAL SFA. THE DEVICE WAS ADVANCED TO THE MID SFA FOR FURTHER TREATMENT. ONE TREATMENT PASS WAS PERFORMED ON LOW SPEED, AND ONE TREATMENT PASS WAS PERFORMED ON MEDIUM SPEED. BOTH TREATMENTS WERE DISTAL TO PROXIMAL. THE PHYSICIAN THEN ACTIVATED THE OAD FOR ANOTHER TREATMENT, BUT AN UNEXPECTED "SQUEAL" SOUND WAS OBSERVED. THE PHYSICIAN THEN DEACTIVATED THE DEVICE. THE WIRE WAS THEN DETERMINED TO BE STUCK IN A SIDE BRANCH. THE OAD FRACTURED. A SUPPORT CATHETER, WHICH WAS ALREADY IN USE, WAS USED TO REMOVE THE OAD FRAGMENT. THE WIRE WAS ALSO FREED THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY AND STENT PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13411872 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED VESSEL SPASM AND SLOW FLOW FOLLOWING ANGIOPLASTY AND TWO TREATMENTS WITH THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) IN THE DORSALIS PEDIS. ACCESS WAS IN THE GROIN, AND TWO TREATMENTS (ON MEDIUM AND LOW SPEED) HAD BEEN PERFORMED. NITROGLYCERIN WAS ADMINISTERED, AND ADDITIONAL ANGIOPLASTY WAS PERFORMED TO RESOLVE SPASM.

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

  MAUDE report 12963050 ↗
• MalfunctionNov 17, 2021Decoupling; Decoupling

  DURING THE PROCEDURE, THE SALINE TUBING BECAME DISCONNECTED NEAR THE SALINE TUBING POSITIONERS. IT IS UNKNOWN WHAT CAUSED THE TUBING TO DISCONNECT. A SECOND OAD WAS OPENED TO USE THE TUBING AND COMPLETE THE PROCEDURE AS THERE WAS PHYSICIAN CONCERN THAT AIR COULD BE INTRODUCED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12829187 ↗
• InjuryOct 6, 2021Entrapment of Device; Entrapment of Device

  DURING ORBITAL ATHERECTOMY TREATMENT, THE CROWN OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE DORSALIS PEDIS ARTERY. THE CROWN WAS ALSO UNABLE TO BE REMOVED FROM THE GUIDE WIRE, AND WHILE SPINNING ON LOW SPEED THE OAD AND WIRE WERE MANUALLY REMOVED FROM THE SHEATH. AFTER REMOVAL, TISSUE WAS OBSERVED TO BE WRAPPED AROUND THE CROWN OF THE OAD AND A TYPE D DISSECTION WAS NOTED WHERE THE CROWN HAD BECOME STUCK. A GUIDE WIRE AND MICROCATHETER WERE USED TO RE-CROSS THE LESION, HOWEVER ACCESS TO THE AREA OF THE DISSECTION COULD NOT BE FULLY OBTAINED AND BALLOON ANGIOPLASTY WAS USED TO PARTIALLY RESOLVE THE DISSECTION. THE PATIENT WAS STABLE, AND AS OF (B)(6) 2021 THE PATIENT'S GANGRENE WOUND HAD SINCE HEALED, INDICATING TO THE PHYSICIAN THAT THE VESSEL DAMAGE HAD FULLY RESOLVED. THEREFORE, NO ADDITIONAL INTERVENTION IS PLANNED.

  Patient problems: Device Embedded In Tissue or Plaque; Vascular Dissection

  MAUDE report 12585132 ↗
• InjuryJul 27, 2021Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF THE DISTAL POSTERIOR TIBIAL ARTERY (PT) AND PROXIMAL PEDAL ARCH. INTRAVENOUS ULTRASOUND SHOWED CALCIUM PROXIMAL TO THE CHRONIC TOTAL OCCLUSION (CTO). ATHERECTOMY WAS PERFORMED ON THE DISTAL SEGMENT OF THE PT. HOWEVER, THE OAD STOPPED SPINNING WHEN IT WAS ADVANCED TO THE CTO SEGMENT. SEVERAL ATTEMPTS TO REACTIVATE THE DEVICE WERE MADE, BUT IT WOULD NOT SPIN AND APPEARED TO BE ENTRAPPED. THE PHYSICIAN ADMINISTERED 1000MCG OF NITROGLYCERIN TO RELIEVE ANY SPASM. NITROGLYCERIN DID NOT HELP TO FREE THE OAD. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE USED TO MANUALLY REMOVE THE OAD, BUT ULTIMATELY THE PATIENT WAS SENT TO SURGERY FOR REMOVAL IN STABLE CONDITION. THE PATIENT EXPERIENCED PAIN DURING REMOVAL ATTEMPTS AND RECEIVED MULTIPLE DOSES OF VERSED AND FENTANYL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Pain

  MAUDE report 12229453 ↗
• InjuryJul 23, 2021Physical Resistance/Sticking

  A CSI ORBITAL ATHERECTOMY WAS PERFORMED ON THE LEFT DISTAL POSTERIOR TIBIAL ARTERY WITH A DIAMONDBACK 360 GEN2 1.25 MM PERIPHERAL OAS. THE DEVICE BECAME LODGED IN THE DISTAL PLANTAR ARTERY DISTAL TO THE POSTERIOR TIBIAL ARTERY AND WAS UNABLE TO BE REMOVED. PATIENT WAS SENT TO THE OPERATING ROOM AND DEVICE WAS REMOVED SUCCESSFULLY. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12225434 ↗
• InjuryJun 23, 2021Adverse 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 POPLITEAL LESION AND HIGHLY DISEASED ANTERIOR TIBIAL ARTERY (AT) VIA FEMORAL ACCESS AND CONTRALATERAL APPROACH. THE POPLITEAL WAS APPROXIMATELY 5MM VESSEL WITH APPROXIMATELY 60% STENOSIS. THE AT WAS DIFFUSELY DISEASED THROUGHOUT WITH 75% TO 100% STENOSIS. TREATMENT WAS PERFORMED ON BOTH VESSELS WITH AUDIBLE FEEDBACK INDICATING TREATMENT OF CALCIUM. THE DEVICE BECAME STUCK ON THE GUIDE WIRE DURING ATTEMPTED REMOVAL. THE OAD AND WIRE HAD TO BE REMOVED TOGETHER, AND THE VESSEL WAS REWIRED. TREATMENT WAS COMPLETED WITH ANGIOPLASTY IN BOTH THE AT AND POPLITEAL. THE GUIDE WIRE WAS REMOVED FROM THE DEVICE EX VIVO, AND THERE APPEARED TO BE SOME TISSUE ON THE CROWN AND NOSE. THE AT EXHIBITED SIGNIFICANT SPASM. THE PHYSICIAN DECIDED AGAINST TREATING THE SPASM IN HOPES IT WOULD RESOLVE ON ITS OWN. THE PATIENT WAS STABLE AND AWAKE AT CONCLUSION OF THE PROCEDURE. THE PHYSICIAN WAS UNSURE IF ATHERECTOMY OR ANGIOPLASTY CAUSED THE SPASM SINCE NO IMAGING WAS PERFORMED BETWEEN THE TREATMENTS.

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

  MAUDE report 12048756 ↗
• InjuryMar 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A 100% OCCLUDED LESION IN THE PROXIMAL POSTERIOR TIBIAL ARTERY. THE LESION WAS PREDILATED WITH BALLOON ANGIOPLASTY AND INTRAVASCULAR ULTRASOUND WAS PERFORMED. OAD TREATMENT WAS PERFORMED, AND A PITCH CHANGE WAS HEARD. THE OAD WAS SHUT OFF, AND A PERFORATION WAS OBSERVED ON IMAGING. BALLOON ANGIOPLASTY WAS PERFORMED, AND THE EXTRAVASATION WAS REMOVED VIA ASPIRATION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 11519876 ↗
• MalfunctionFeb 4, 2021Adverse 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 SEVERELY CALCIFIED LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. DURING PROXIMAL TO DISTAL TREATMENT, UNEXPECTED MOVEMENT WAS OBSERVED, AND A SMALL PIECE OF MATERIAL WAS PRESENT IN THE VESSEL AS SEEN ON IMAGING. THE OAD WAS REMOVED, AND A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE. IN THE PHYSICIAN'S OPINION, THE FRAGMENT WAS SMALL AND INSIGNIFICANT, SO NO ATTEMPT TO RETRIEVE THE FRAGMENT WAS MADE. NO ADDITIONAL PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11279825 ↗