Diamondback Peripheral DBP-EX-150SOL145Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10852528005831), received between Dec 23, 2020 and Jun 19, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE TARGET AREA OF TREATMENT WAS THE SUPERFICIAL FEMORAL ARTERY. IT WAS DIFFICULT TO ADVANCE THE DIAMONDBACK EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) THROUGH THE ANTERIOR TIBIAL (AT) ARTERY THAT WAS HEAVILY CALCIFIED, ABOUT 3 MM IN LENGTH AND 90%-95% OCCLUDED. THE PHYSICIAN ATTEMPTED TO TREAT IN THE AT AND POPLITEAL ARTERY. WHEN SPINNING THE OAD IN THE AT, THE DEVICE SPEED DROPPED AND EVENTUALLY THE OAD STOPPED SPINNING. THE LED LIGHTS ON THE OAD REMAINED ILLUMINATED. IT WAS BELIEVED THE OAD STOPPED SPINNING DUE TO THE HEAVY CALCIFICATION IN THE AT. THE OAD WAS REMOVED WITHOUT ANY COMPLICATIONS. ANGIOGRAPHY WAS CHECKED AND PERFORATION WAS OBSERVED IN THE AT. ANGIOPLASTY WAS PERFORMED TO TREAT THE PERFORATION. THE SAME OAD WAS ADVANCED AND WAS ABLE TO CROSS THE AT TO TREAT THE SFA WITHOUT ISSUE. THE PHYSICIAN WRAPPED THE PATIENT'S LEG TO TREAT THE HEMATOMA THAT OCCURRED IN THE MID SHIN REGION. IN THE PHYSICIAN'S OPINION, THE OAD CAUSED THE PERFORATION AND THERE WAS NO CROWN JUMPING OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE HEMATOMA WAS FROM THE ORBITAL ATHERECTOMY SYSTEM INTERACTION WITH THE LESION. THE PATIENT WAS HOSPITALIZED AND WAS IN OBSERVATION. THE PATI

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 19568319 ↗
• InjuryNov 3, 2023Contamination; Off-Label Use; Contamination; Off-Label Use

  THE DIAMONDBACK 360 EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS AN IN-STENT CHRONIC TOTAL OCCLUSION (CTO). A SINGLE VESSEL RUNOFF TO THE ANTERIOR TIBIAL ARTERY (AT) WAS OBSERVED PRIOR TO TREATMENT. AFTER TREATMENT, NO DISSECTIONS WERE OBSERVED, HOWEVER, THE AT APPEARED TO BE OCCLUDED. WHEN OBSERVING THE CROWN, BIOLOGICAL DEBRIS WAS NOTICED. THE AT WAS RE-OPENED WITH A BALLOON AND TISSUE PLASMINOGEN ACTIVATOR WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES.

  Patient problems: Obstruction/Occlusion

  MAUDE report 18067409 ↗
• MalfunctionOct 7, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING REMOVAL OF A DIAMONDBACK PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) THE DEVICE BECAME STUCK IN THE SHEATH. THE OAD WAS PULLED AND THE CROWN BROKE OFF INSIDE THE SHEATH. THE CROWN FRAGMENT REMAINED IN THE SHEATH AND A SHEATH EXCHANGE WAS PERFORMED WITHOUT LOSING WIRE POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594262 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A DISTAL LESION IN THE SUPERFICIAL FEMORAL ARTERY. IMAGING PRIOR TO THE PROCEDURE REVEALED THAT THE PERONEAL AND POSTERIOR TIBIAL (PT) ARTERIES HAD GOOD FLOW. FOUR TREATMENTS WERE ADMINISTERED WITH THE OAD, IMAGING WAS PERFORMED FOLLOWING SUBSEQUENT ANGIOPLASTY, AND SLOW FLOW WAS OBSERVED IN THE PT WITH DISTAL EMBOLIZATION PRESENT. NITROGLYCERIN AND ANGIOPLASTY WERE USED TO IMPROVE FLOW, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

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

  MAUDE report 11922312 ↗
• MalfunctionDec 23, 2020Entrapment of Device; Entrapment of Device

  DURING ORBITAL ATHERECTOMY TREATMENT ON A LESION IN THE POPLITEAL ARTERY, THE PERIPHERAL EXCHANGEABLE ORBITAL ATHERECTOMY DEVICE (OAD) STALLED AND STOPPED SPINNING. THE OAS PUMP LIGHT WAS OBSERVED TO BE YELLOW AND ALL CONNECTIONS WERE FOUND TO BE SECURE. THE PUMP WAS POWERED ON AND ALL LEDS ON THE OAD HANDLE WERE ILLUMINATED, SO THE DEVICE WAS REMOVED. DURING DEVICE REMOVAL THE OAD WAS UNABLE TO MOVE BACKWARD ON THE GUIDE WIRE AND BOTH THE WIRE AND DEVICE WERE REMOVED FROM THE PATIENT. THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH A SECOND OAD. DUE TO THE TIME REQUIRED TO REMOVE THE DEVICE AND RE-WIRE THE LESION, A DELAY OF 30 MINUTES OR GREATER OCCURRED. THERE WERE NO PATIENT ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11069244 ↗