Diamondback Peripheral DBP-EX-200CLA145Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10852528005916), received between Jan 6, 2020 and Jul 25, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Break; Fluid/Blood Leak; Air/Gas in Device; Break; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT DURING SETUP THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) AND SALINE LINE WERE TAKEN OUT OF THE PACKAGING AND CONNECTED TO PUMP. THE OAD WAS NOT CONNECTED TO PATIENT OR VIPERWIRE ADVANCE GUIDE WIRE. THE GREEN START BUTTON ON THE PUMP WAS PRESSED TO START SALINE FLOW THROUGH THE SALINE TUBING. THE GREEN LED LIGHT WAS LIT. THE PRIME BUTTON ON THE PUMP WAS THEN PRESSED TO PURGE AIR FROM THE SALINE TUBING BUT BUBBLES WERE OBSERVED INSIDE THE TUBING. CLOSER EXAMINATION OF TUBING REVEALED FLUID LEAK FROM PINHOLE LOCATED BETWEEN A SALINE TUBING POSITIONER AND THE SALINE BAG SPIKE. THE OAD AND SALINE TUBING WERE BOTH REPLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE IS NO INDICATION AS TO WHAT CAUSED THE PINHOLE AS THERE WAS NO DAMAGE TO THE OAD PACKAGING OR TRAY INDICATING THE DAMAGE OCCURRED DURING TRANSIT OR HANDLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609956 ↗
• InjuryJan 6, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE DIAMONDBACK EXCHANGEABLE PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A PATIENT WHO WAS VERY SICK, ACCORDING TO THE PHYSICIAN. SUCCESSFUL TREATMENT OF THE SUPERIOR FEMORAL ARTERY WAS PERFORMED WITH A 2.0MM CARTRIDGE. THE OAD WAS THEN REDIRECTED TO THE PERONEAL ARTERY WITH A 1.25MM CARTRIDGE. THE DRIVESHAFT WAS ONLY ADVANCED ABOUT HALFWAY FOR TREATMENT. FOLLOWING TREATMENT IN THE PERONEAL ARTERY, GLIDEASSIST WAS ACTIVATED, AND THE OAD WAS ADVANCED THE REST OF THE WAY SO THAT WIRE EXCHANGE COULD BE ACHIEVED WITHOUT LOSING WIRE POSITION. THE OAD WAS THEN SUBINTIMAL, BUT THE PHYSICIAN WAS NOT AWARE OF THIS AT THE TIME. THE WIRE COULD NOT BE REMOVED FOR EXCHANGE. THE DEVICE WAS WRAPPED AROUND THE WIRE AND THE SUBINTIMA. DESPITE USE OF A SNARE AND A BALLOON, THE OAD COULD NOT BE REMOVED. THE PHYSICIAN THEN PULLED ON THE OAD, AND IT RETRACTED TO THE POPLITEAL ARTERY. UNSUCCESSFUL ATTEMPTS WERE MADE FOR FIVE HOURS TO FREE THE OAD, DURING WHICH THE DRIVESHAFT OF THE OAD FRACTURED. THEREAFTER, SURGERY WAS CONSULTED. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE DURING THE EVENT. THE PATIENT WAS TRANSFERRED TO THE CORONARY CARE UNIT AND EXPIRED THERE. THE P

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

  MAUDE report 9554658 ↗