Diamondback Peripheral DBP-150SOLID200 (REF 7-10057-06)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10850000491226), received between Apr 14, 2021 and Mar 31, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 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 THREE FOCAL CHRONIC TOTAL OCCLUSIONS IN THE FEMORAL AND POPITEAL ARTERIES. EACH LESION WAS ABOUT 1CM IN LENGTH. THE OAD WAS USED ON LOW, MEDIUM, AND HIGH SPEED ONE LESION AT A TIME FROM PROXIMAL TO DISTAL. IMAGING THEREAFTER SHOWED NO FLOW AT ALL BELOW THE KNEE, WHEREAS FLOW HAD BEEN PRESENT PRIOR. THE PATIENT WAS SENT TO SURGERY FOR A THROMBECTOMY AND BYPASS. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE. IN THE OPINION OF THE PHYSICIAN, NO FLOW WAS CAUSED BY DISTAL EMBOLIZATION FROM OA.

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

  MAUDE report 13965285 ↗
• InjuryFeb 14, 2022Material Separation; Material Separation

  DIFFICULTY WAS ENCOUNTERED ADVANCING A 6 FRENCH SHEATH THROUGH THE CALCIFIED AORTIC BIFURCATION, AND THE SHEATH WAS INSTEAD PLACED IN THE PROXIMAL RIGHT COMMON ILIAC. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT THE COMMON FEMORAL AND PROXIMAL SUPERFICIAL FEMORAL ARTERY ON LOW SPEED. THE OAD WAS OPERATED ON MEDIUM SPEED AND AN USUAL NOISE WAS OBSERVED AND THE OAD STOPPED SPINNING. DURING ATTEMPTS TO REMOVE THE OAD THE DEVICE BECAME STUCK INSIDE THE SHEATH AT THE AORTIC BIFURCATION. THE OAD WAS PULLED AND THE DRIVESHAFT FRACTURED. A NON-CSI GUIDE WIRE WAS INSERTED TO MAINTAIN WIRE ACCESS AND A BALLOON WAS INSERTED TO INFLATE THE CROWN INTO PLACE IN THE SHEATH. THE SHEATH WAS REMOVED AND THE VIPERWIRE AND NON-CSI WIRE REMAINED IN VIVO. THE PROCEDURE WAS COMPLETED WITH A SECOND SHEATH AND BALLOON ANGIOPLASTY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13523641 ↗
• InjuryApr 14, 2021Entrapment of Device; Entrapment of Device

  DURING A PROCEDURE, THE VIPERWIRE GUIDE WIRE WAS INADVERTENTLY ADVANCED INTO THE COLLATERAL ARTERY AND THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) SHUT DOWN AFTER BECOMING STUCK IN THE VESSEL. AFTER ONE HOUR OF TROUBLESHOOTING, A BALLOON WAS USED TO FREE THE OAD FROM THE VESSEL AND A SMALL PERFORATION WAS IDENTIFIED. A PROLONGED BALLOON INFLATION WAS USED TO RESOLVE THE PERFORATION AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. PER THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE PERFORATION EVENT WAS DUE TO INADVERTENTLY OPERATING IN THE COLLATERAL ARTERY.

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

  MAUDE report 11668928 ↗