Diamondback Peripheral DBP-EX-125SOL145Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10852528005824), received between Apr 20, 2021 and Apr 10, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2025Material Separation; Insufficient Flow or Under Infusion; Material Separation; Insufficient Flow or Under Infusion

  A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS BEING USED TO TREAT A 70% STENOSED POSTERIOR TIBIAL ARTERY (PT). WHEN THE OAD WAS IN VIVO, IT WAS OBSERVED THAT BLOOD WAS COMING BACK UP INTO THE DRIVESHAFT OF THE OAD AND EXITING ABOUT FOUR INCHES FROM THE OAD NOSECONE. THE PHYSICIAN DIDN'T HAVE SUPPORT TO MOVE THE OAD CROWN, SO THE OAD WAS REMOVED FROM THE PATIENT FOR ASSESSMENT. EX VIVO, IT WAS OBSERVED THE OUTER COVERING OF THE SPRING COILS LOOKED DISCONNECTED FROM THE OAD NOSECONE, AS IF IT HAD MOVED UP. THE SALINE SHEATH WASN'T THERE TO SUPPORT THE SPRING COILS AND BLOOD WAS EXITING THROUGH THAT SPOT. IT WAS POSSIBLE THE SHEATH DISCONNECTED WHILE ENTERING THE PATIENT, BUT IT WAS UNABLE TO BE CONCLUSIVELY DETERMINED IF THAT HAD BEEN THE CASE. DUE TO BLOOD BACKING UP, A NEW OAD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT AND NO CLINICALLY SIGNIFICANT DELAY. THE FLOW OF SALINE TO THE TIP OF THE OAD WAS CONSIDERED SUFFICIENT ENOUGH TO AVOID INJURY TO THE PATIENT. CONTRAST AND VASODILATORS WERE ADMINISTERED THROUGH THE OAD DURING THE PROCEDURE. FORWARD SALINE FLOW DID NOT STOP FOR ANY REASON DURING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21817082 ↗
• InjuryMar 20, 2025Entrapment of Device; Activation Problem; Entrapment of Device; Activation Problem

  IT WAS REPORTED LEFT FEMORAL ACCESS WAS USED WITH A 6F NON-ABBOTT SHEATH AND A WIRE EXCHANGE WAS PERFORMED FOR THE VIPERWIRE GUIDE WIRE. THE DIAMONDBACK 360 PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TWO LOW SPEED TREATMENTS AND ONE MEDIUM SPEED TREATMENT OF A HEAVILY CALCIFIED RIGHT ANTERIOR TIBIAL ARTERY (AT). THE PHYSICIAN ATTEMPTED TO ADVANCE THE OAD FURTHER DOWN THE AT, HOWEVER, THEY WERE UNABLE TO ADVANCE FURTHER. THE PHYSICIAN PUT THE OAD IN GLIDEASSIST MODE. DURING ADVANCEMENT, GLIDEASSIST SLOWED DOWN AND THE LOSS IN SPEED WAS OBSERVED AUDIBLY. IT APPEARED THAT THE OAD WAS STUCK IN VESSEL THAT RESULTED ON LOSS OF SPEED. IT WAS RECOMMENDED FOR THE OAD TO BE REMOVED. THE OAD WAS PUT IN GLIDEASSIST MODE IN AN ATTEMPT TO REMOVE THE DEVICE. THE SAME ISSUE OCCURRED DURING REMOVAL. GLIDEASSIST MODE SLOWED AND STOPPED. THE OAD WAS UNABLE TO BE REMOVED AND IT WAS INDICATED THE AT SPASMED. VERAPAMIL AND A FULL RADIAL COCKTAIL WERE ADMINISTERED. THE SPASM DID NOT RESOLVE. THE PHYSICIAN ENDED UP CUTTING THE TIP OF THE OAD, HOPING TO RELIEVE PRESSURE, BUT THE ISSUE REMAINED UNRESOLVED. A GUIDE CATHETER AND A NEW VIPERWIRE WERE INSERTED IN AN ATTEMPT TO LOOSEN

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 21656842 ↗
• MalfunctionJan 16, 2025Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Improper or Incorrect Procedure or Method; Device Damaged by Another Device

  IT WAS REPORTED THAT A COMMAND GUIDE WIRE WAS ATTEMPTED TO BE EXCHANGED FOR A VIPERWIRE ADVANCE GUIDE WIRE, HOWEVER, DUE TO THE HEAVILY CALCIFIED ANATOMY IT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO CONTINUE TO USE THE COMMAND GUIDE WIRE WITH THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). A LOW SPEED AND MEDIUM SPEED TREATMENT WERE PERFORMED. THE OAD MADE CONTACT WITH THE WIRE RADIOPAQUE TIP. THE OAD WAS REMOVED AND THE WIRE REMAINED IN VIVO FOR ADDITIONAL TREATMENTS. ONCE THE WIRE WAS REMOVED, IT WAS OBSERVED TO HAVE FRACTURED. THE FRACTURED WIRE REMAINS IN VIVO. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172265 ↗
• InjuryJun 12, 2024Entrapment of Device; Entrapment of Device

  A DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN THE LEFT POSTERIOR TIBIAL ARTERY. THE PATIENT HAD SURGERY TO CUT AND REMOVE THE OAD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19519936 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ONE LOW-SPEED AND ONE HIGH-SPEED TREATMENT OF A 90% STENOSED, MODERATELY CALCIFIED LESION IN THE ANTERIOR TIBIAL (AT) ARTERY USING THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) VIA FEMORAL ANTEGRADE ACCESS, ANGIOGRAPHIC IMAGING REVEALED NO FLOW AND EMBOLISM. THE ENTIRE VESSEL INTO THE FOOT SHUT DOWN. BALLOON ANGIOPLASTY DID NOT RESTORE FLOW. THE PATIENT WAS ADMITTED TO INTENSIVE CARE UNIT (ICU) AND ANTI-COAGULANT AND BLOOD THINNERS WERE ADMINISTERED OVERNIGHT.

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

  MAUDE report 18119218 ↗
• MalfunctionMar 17, 2023Material Separation; Material Separation

  DURING TREATMENT, THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK ON THE VIPERWIRE ADVANCE GUIDE WIRE. THE OAD AND VIPERWIRE WERE REMOVED AND REPLACED. THE PATIENT WAS STABLE. DURING ANALYSIS OF THE OAD, SPRING TIP DAMAGE WAS OBSERVED. IT WAS UNKNOWN WHEN THE DAMAGE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16566908 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE POSTERIOR TIBIAL ARTERY. TREATMENT WAS PERFORMED ON LOW SPEED. WHEN PERFORMING TREATMENT ON MEDIUM SPEED, THE DEVICE STALLED AND STOPPED SPINNING DUE TO A VESSEL SPASM. THE CATHETER WAS FLUSHED, AND THE WIRE WAS ADVANCED FORWARDS AND BACKWARDS TO LOOSEN THE DEVICE. THE OAD WAS REMOVED FROM THE PATIENT. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

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

  MAUDE report 15384844 ↗
• InjuryJul 20, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  A TREATMENT WAS PERFORMED IN THE 3 MM, HEAVILY CALCIFIED LESION IN THE PROXIMAL ANTERIOR TIBIAL (AT) DIAMONDBACK 360 EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) ON LOW SPEED. THE DEVICE WAS FLUSHED, AND A SECOND TREATMENT WAS PERFORMED ON LOW SPEED WHEN THE CROWN BECAME STUCK. GLIDEASSIST WAS ACTIVATED, BUT MULTIPLE ATTEMPTS TO REMOVE THE CROWN WERE UNSUCCESSFUL. TWO TREATMENTS OF INTRA-ARTERIAL NITROGLYCERIN WERE ADMINISTERED VIA THE OAD. THE OAD WAS FLUSHED WITH VIPERSLIDE, AND GLIDEASSIST WAS ACTIVATED, BUT THE CROWN REMAINED STUCK. BY HOLDING THE WIRE, THE OAD WAS ABLE TO BE REMOVED SUCCESSFULLY. ANGIOGRAPHIC IMAGING REVEALED GOOD FLOW AND NO DISSECTION. BALLOON ANGIOPLASTY WAS USED. A NEW OAD AND WIRE WERE USED TO TREAT TWO ADDITIONAL LESIONS WHICH RESTORED COMPLETE FLOW TO THE PEDAL ARCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15067636 ↗
• InjuryNov 22, 2021Entrapment of Device; Entrapment of Device

  A DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED VIA PEDAL ACCESS AND ANTEGRADE APPROACH TO TREAT A CHRONIC TOTAL OCCLUSION IN THE LEFT ANTERIOR TIBIAL ARTERY. ATHERECTOMY WAS PERFORMED ON LOW SPEED PROXIMAL-TO-DISTAL THROUGHOUT THE LESION. THE OAD WAS UNABLE TO SPIN BACK TO THE PROXIMAL STARTING POINT. A CATHETER WAS INSERTED AND ADVANCED TO THE OAD NOSE, WHICH FREED THE DEVICE; HOWEVER, THE DEVICE WAS STUCK ON THE GUIDE WIRE AND DUE TO THE TISSUE WRAPPED AROUND THE DRIVESHAFT, THE DEVICE WAS UNABLE TO BE REMOVED THROUGH THE SHEATH. A BUDDY WIRE WAS ADVANCED TO THE LEFT SUPERFICIAL FEMORAL ARTERY AND THE OAD, VIPERWIRE GUIDE WIRE AND SHEATH WERE THEN REMOVED TOGETHER. TISSUE WRAP WAS OBSERVED ON BOTH THE GUIDE WIRE AND OAD. THE CATHETER THAT WAS USED TO FREE THE OAD WAS USED TO MAINTAIN WIRE ACCESS, THE VESSEL WAS REWIRED, AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. ADDITIONAL REVIEW OF IMAGING CONFIRMED THAT THE CSI DEVICE WAS SUBINTIMAL WHEN THE DEVICE BECAME STUCK IN THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12855986 ↗
• InjuryApr 20, 2021Material Separation; Material Separation

  THE DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT LESIONS IN THE TIBIOPERONEAL TRUNK AND THE SUPERFICIAL FEMORAL ARTERY VIA FEMORAL ACCESS. THE AORTO-ILIAC BIFURCATION WAS VERY ACUTE IN ANGULATION, AND THE COMMON ILIAC ARTERIES WERE HEAVILY CALCIFIED AND TORTUOUS. THE OAD WAS PULLED BACK THROUGH THE GUIDE CATHETER, AND THE DRIVESHAFT FRACTURED. THE FRAGMENT WAS SNARED VIA ADDITIONAL ACCESS IN THE RIGHT COMMON FEMORAL ARTERY. THE PROCEDURE WAS THEN COMPLETED USING THE NEW ACCESS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11692185 ↗