Diamondback Peripheral DBP–200CLASS145Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10852528005268), received between Feb 7, 2018 and Sep 30, 2020 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2020Material Separation; Material Separation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED THROUGH A TIGHT LESION IN THE SUPERFICIAL FEMORAL ARTERY THAT WAS SEVERELY CALCIFIED, 99% STENOSED AND A CHRONIC TOTAL OCCLUSION. THE OAD WAS UNABLE TO CROSS THE LESION, AND THE CROWN OF THE OAD UNRAVELED AND THE TIP OF THE OAD AND CROWN FRACTURED. THE FRAGMENT REMAINED ON THE VIPERWIRE GUIDE WIRE, AND THE OAD AND GUIDE WIRE WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10607115 ↗
• InjuryAug 20, 2018Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE CROWN OF THE DEVICE BECAME DETACHED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING TREATMENT WITH THE OAD, THE DEVICE WAS TURNED OFF AND IT WAS NOTED THAT THE CROWN WAS DETACHED AND LOCATED DISTAL TO THE END OF THE DEVICE. AN ATTEMPT WAS MADE TO RETRIEVE THE CROWN, HOWEVER THE SNARE WAS NOT ABLE TO TRAVERSE THE VESSEL. THE CROWN MIGRATED TO THE ANTERIOR TIBIAL ARTERY AND REMAINED IN THE PATIENT. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 7798342 ↗
• MalfunctionJul 13, 2018Entrapment of Device; Material Separation; Detachment of Device or Device Component; Entrapment of Device; Material Separation; Detachment of Device or Device Component

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE LESION RESULTING IN A PROCEDURAL DELAY. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE POPLITEAL. DURING TREATMENT OF THE LESION, THE DEVICE STALLED AND BECAME STUCK IN THE LESION. THE OAD WAS DISASSEMBLED AND A GUIDE CATHETER WAS INSERTED IN ORDER TO REMOVE THE DEVICE, RESULTING IN A ONE HOUR PROCEDURAL DELAY. THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7687059 ↗
• MalfunctionJul 6, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE LESION RESULTING IN A PROCEDURAL DELAY. THE TARGET LESION WAS A TOTAL OCCLUSION AND WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING ATHERECTOMY TREATMENT, THE OAD MADE AN ABNORMAL NOISE AND BECAME STUCK IN THE LESION AND STALLED. THE CROWN WOULD NOT RETRACT INTO THE SHEATH, AND A LARGER SHEATH WAS INSERTED IN ORDER TO REMOVE THE OAD. THIS RESULTED IN A PROCEDURE DELAY OF ONE HOUR. THE PROCEDURE WAS THEN COMPLETED WITH BALLOON ANGIOPLASTY AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667153 ↗
• InjuryJun 18, 2018Device Stops Intermittently; Device Stops Intermittently

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS COMPLETELY STENOSED AND LOCATED IN THE MID SUPERFICIAL FEMORAL ARTERY. DURING ATHERECTOMY TREATMENT, THE OAD LOST POWER MULTIPLE TIMES. FOLLOWING ATHERECTOMY AND BALLOON ANGIOPLASTY, IMAGING WAS PERFORMED AND A FLOW LIMITING DISSECTION WAS NOTED. A STENT WAS PLACED TO RESOLVE THE DISSECTION AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7611513 ↗
• InjuryFeb 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE COMMON FEMORAL ARTERY. THE LESION WAS TREATED USING THE OAD ON LOW SPEED, HOWEVER WHEN THE DEVICE WAS OPERATED ON HIGH SPEED IT WOULD CONTINUOUSLY LOSE POWER. WHEN THE DEVICE WOULD REGAIN POWER, THE CROWN WOULD RESUME SPINNING. THE DEVICE WAS REPLACED AND TREATMENT WAS CONTINUED. AFTER USE OF THE SECOND OAD, A DISSECTION WAS NOTED. A STENT WAS PLACED TO RESOLVE THE DISSECTION AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7249456 ↗