Diamondback Peripheral DBP–150CLASS145Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10852528005251), received between Oct 26, 2016 and Jul 18, 2019 — classified as 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2019Entrapment of Device; Noise, Audible; Entrapment of Device; Noise, Audible

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS UNABLE TO BE REMOVED FROM THE VESSEL. THE TARGET, 80% STENOSED LESION WAS LOCATED IN AN AREA OF THE MID-ANTERIOR TIBIAL ARTERY THAT WAS 3.00MM IN DIAMETER. FOLLOWING TWO TREATMENT PASSES, THE CROWN WAS STUCK ON SOMETHING, AND THE DEVICE MADE AN UNUSUAL NOISE. THE CROWN WOULD MOVE FORWARD IN THE VESSEL BUT WOULD NOT BACK THROUGH THE VESSEL. IT WAS NOTED THE CROWN WAS STUCK IN THE VESSEL, AND A PERFORATION HAD OCCURRED. THE PATIENT WAS TRANSFERRED FOR SURGICAL REMOVAL. THE REMOVAL WAS SUCCESSFUL, AND THE PATIENT WAS FINE FOLLOWING THE REMOVAL.

  Patient problems: Perforation of Vessels

  MAUDE report 8804097 ↗
• MalfunctionJul 17, 2019Entrapment of Device; Entrapment of Device

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 99% STENOSED TARGET LESION LOCATED IN THE POSTERIOR TIBIAL ARTERY (PT). THE LESION WAS SEVERELY CALCIFIED AND THE ARTERY WAS NOT TORTUOUS. AFTER FOUR TREATMENT PASSES, THE OAD BECAME STUCK ON THE GUIDE WIRE. THE OAD AND GUIDE WIRE WERE REMOVED FROM THE PATIENT TOGETHER, AND THE GUIDE WIRE WAS REMOVED FROM THE REAR OF THE OAD. THE VESSEL WAS RE-WIRED WITH A SECOND GUIDE WIRE, AND REWIRING RESULTED IN A DELAY OF APPROXIMATELY 20 MINUTES TO THE PROCEDURE. THE SECOND GUIDE WIRE WOULD NOT PASS THROUGH THE INITIAL OAD, AND MULTIPLE ATTEMPTS AT BALLOON ANGIOPLASTY WERE PERFORMED. THE DISTAL VESSEL WAS NOT ABLE TO BE OPENED, AND NO ADDITIONAL TREATMENT WAS REPORTED IN THE POSTERIOR TIBIAL ARTERY. A SECOND OAD WAS USED TO CONTINUE THE PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. AFTER TREATMENT IN THE SFA AND POPLITEAL, BALLOON ANGIOPLASTY WAS PERFORMED. AFTER BALLOON ANGIOPLASTY, A TYPE B DISSECTION WAS OBSERVED. THE PHYSICIAN STATED THE SECOND OAD DID NOT CONTRIBUTE TO THE DISSECTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8799425 ↗
• InjuryJun 3, 2019Entrapment of Device; Entrapment of Device

  DURING TREATMENT OF A CHRONIC TOTAL OCCLUSION WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS DIFFICULT FOR THE DEVICE TO CROSS THE LESION AND IT BECAME STUCK IN BOTH THE LESION AND ON THE GUIDE WIRE. THE SHEATH OF THE OAD WAS CUT AND ADVANCED OVER THE CROWN IN ORDER TO REMOVE THE DEVICE AND THE DEVICE AND GUIDE WIRE WERE REMOVED. THE LESION WAS RE-WIRED AND THE PROCEDURE WAS COMPLETED WITH AN OAD OF A SMALLER CROWN SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 8664140 ↗
• MalfunctionOct 30, 2018Premature Activation; Premature Activation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) REPORTEDLY SHUT DOWN AND STARTED BACK UP WITHOUT THE USER PROMPTING IT TO. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY AND WITHOUT ANY FURTHER ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8020330 ↗
• InjuryApr 2, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME STUCK IN THE PATIENT AND REQUIRED SURGICAL REMOVAL. THE TARGET LESIONS WERE LOCATED IN THE SUPERFICIAL FEMORAL, POPLITEAL AND TIBIAL-PERONEAL TRUNK ARTERIES. FOLLOWING TREATMENT OF THE FIRST TWO LESIONS WITH THE OAD, THE DEVICE STOPPED FUNCTIONING AND BECAME STUCK DURING TREATMENT OF THE TIBIAL-PERONEAL TRUNK. THE DEVICE WAS CUT AT THE HUB AND MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE DEVICE, BUT WERE UNSUCCESSFUL. SURGERY WAS PERFORMED TO REMOVE THE DEVICE, AND IT WAS FOUND THAT THE CROWN HAD PERFORATED THE VESSEL WALL. THE CROWN WAS REMOVED, THE VESSEL WAS REPAIRED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7390240 ↗
• MalfunctionFeb 12, 2018Device Operates Differently Than Expected

  PHYSICIAN WAS USING THE DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, THE DEVICE WAS OPERATING AS INTENDED AT LOW AND MEDIUM SPEED. WHEN PHYSICIAN SWITCHED TO HIGH SPEED THE DEVICE FAILED TO INCREASE SPEED. NO ADVERSE EFFECT ON PATIENT. MANUFACTURER RESPONSE FOR CATHETER, PERIPHERAL, ATHERECTOMY, DIAMONDBACK PERIPHERAL (PER SITE REPORTER). COMPANY VENDOR MADE AWARE AND WILL BE PICKING PRODUCT UP FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7262928 ↗
• InjuryJan 19, 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 PERFORATION OCCURRED. THE TARGET LESION WAS 95% STENOSED AND LOCATED IN THE PROXIMAL ANTERIOR TIBIAL (AT) ARTERY. THE LESION WAS TREATED WITH THE OAD USING TWO PASSES ON LOW SPEED AND TWO PASSES ON MEDIUM SPEED. WHEN THE OAD WAS REMOVED FROM THE PATIENT, A PERFORATION WAS NOTED IN THE AT. BALLOON ANGIOPLASTY WAS PERFORMED TO RESOLVE THE PERFORATION, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7205978 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS REPORTED THAT A PERFORATION OCCURRED. THE TARGET LESION WAS HEAVILY CALCIFIED, AND WAS ACCESSED THROUGH THE GROIN. THE LESION WAS TREATED USING TWO PASSES WITH THE OAD, HOWEVER THE DEVICE THEN BECAME STUCK IN THE VESSEL. A CUTDOWN WAS PERFORMED TO REMOVE THE DEVICE, AND THE GUIDE WIRE WAS NOTED TO BE KINKED. IMAGING WAS PERFORMED AND A PERFORATION WAS NOTED IN THE LATERAL PLANTAR ARTERY. THE PERFORATION WAS RESOLVED WITHOUT FURTHER INTERVENTION, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7070544 ↗
• InjuryOct 26, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PERONEAL ARTERY. THE PHYSICIAN ADVANCED A CSI VIPERWIRE FLEXTIP GUIDE WIRE ACROSS THE LESION AND LOADED A CSI ORBITAL ATHERECTOMY DEVICE (OAD) ONTO IT. AN UNKNOWN NUMBER OF RUNS WERE COMPLETED, BUT POST-ATHERECTOMY ANGIOGRAPHY REVEALED THAT THE GUIDE WIRE APPEARED TO HAVE A WINDING APPEARANCE. THE OAD AND GUIDE WIRE WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PHYSICIAN THEN PERFORMED BALLOON ANGIOPLASTY. POST-ANGIOPLASTY ANGIOGRAPHY REVEALED A PERFORATION. NO ADDITIONAL INTERVENTION WAS PERFORMED TO RESOLVE THE PERFORATION. IT COULD NOT BE DETERMINED WHETHER OR NOT THE CSI GUIDE WIRE OR OAD CONTRIBUTED TO THE PERFORATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS DENIED BY THE FACILITY.

  Patient problems: Perforation of Vessels

  MAUDE report 6058113 ↗