Diamondback Peripheral DBP-150SOLID145 (REF 7-10011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10852528005237), received between Nov 10, 2016 and Nov 22, 2020 — classified as 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 2020Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  PROXIMAL TO DISTAL TREATMENT WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS PERFORMED IN THE PERONEAL ARTERY. IMAGING SHOWED VESSEL SPASM, BUT TREATMENT WAS CONTINUED. THE DEVICE STALLED AND BECAME STUCK IN THE ARTERY. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE DEVICE, AND THE DRIVESHAFT FRACTURED ON THE PROXIMAL EDGE OF THE CROWN. THE PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE FRAGMENT. THE PATIENT MADE A FULL RECOVERY FOLLOWING SURGERY. IN THE OPINION OF THE PHYSICIAN, THE CROWN SELECTED WAS TOO LARGE FOR THE VESSEL, AND OA SHOULD NOT HAVE BEEN USED DURING SPASM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 10881614 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A CTO LESION IN THE SUPERFICIAL FEMORAL AND ANTERIOR TIBIAL ARTERIES. PEDAL ACCESS WAS OBTAINED AND ORBITAL ATHERECTOMY WAS SUCCESSFULLY PERFORMED, HOWEVER AN EMBOLIZATION OF PLAQUE AND MATTER WAS OBSERVED WITHIN THE 6 FR SHEATH. THE SHEATH WAS CLEANED AND RE-INSERTED BACK INTO THE PATIENT TO CONTINUE THE PROCEDURE WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS REPORTED TO BE DOING WELL

  Patient problems: Embolism

  MAUDE report 10395178 ↗
• MalfunctionNov 21, 2019Entrapment of Device; Entrapment of Device

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE BECAME STUCK ON THE GUIDE WIRE UPON REMOVAL DURING THE PROCEDURE. THE TROUBLESHOOTING PERFORMED TO RESOLVE THE ISSUE CAUSED A PROCEDURAL DELAY OF OVER THIRTY MINUTES. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356328 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ATHERECTOMY WAS PERFORMED ON LOW, MEDIUM, AND HIGH SPEEDS WITH A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE. THE TREATMENTS WERE PERFORMED IN THE POPLITEAL ARTERY. A STENT WAS PLACED WITH GOOD ANGIOGRAPHIC RESULT. IMAGING SHOWED POSSIBLE SPASM AND EMBOLIZATION IN THE POSTERIOR TIBIAL (PT) ARTERY. ATTEMPTS TO REWIRE THE VESSEL WITH A NON-CSI WIRE CAUSED A COMPLICATION IN THE PT ARTERY. THIS COMPLICATION WAS NOT CAUSED BY CSI PRODUCT. THE COMPLICATION WAS NOT TREATED; THE PATIENT WAS MONITORED. THE PATIENT HAD AN OBSERVABLE PULSE IN THE PT ARTERY ON ULTRASOUND AND WAS DISCHARGED ON (B)(6) 2019.

  Patient problems: Embolism; No Code Available

  MAUDE report 9167518 ↗
• MalfunctionApr 17, 2019Infusion or Flow Problem; Infusion or Flow Problem

  FLUID LEAKED FROM THE HANDLE AND SALINE TUBING OF THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) DURING DEVICE PREPARATION. THE SALINE DID NOT FLOW OUT OF THE TIP OF THE OAD. A SECOND OAD WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523335 ↗
• InjuryApr 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE, A PIECE OF THE NOSE CONE OF THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) BECAME DETACHED. THE NOSE CONE WAS REATTACHED AND RELOADED OVER THE VIPERWIRE. BLOOD BEGAN TO BACKFILL INTO THE OAD DURING INSERTION OF THE OAD INTO THE INTRODUCER SHEATH. SALINE WAS OBSERVED FLOWING FROM THE NOSE CONE AREA. THE PROCEDURE WAS COMPLETED WITH A SECOND OAD AND PLANNED ANGIOPLASTY AND STENT PLACEMENT. THERE WERE NO OTHER COMPLICATIONS, AND THE PATIENT WAS DISCHARGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8499031 ↗
• MalfunctionFeb 22, 2019Intermittent Loss of Power; Intermittent Loss of Power

  DURING A PROCEDURE, THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) UNEXPECTEDLY SHUT OFF. THE TARGET LESION WAS 15 CM LONG, 60-70% STENOSED WITH MODERATE TO SEVERE CALCIFICATION AND LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THROUGHOUT THE POPLITEAL ARTERY. THE INITIAL OAD USED WOULD NOT REMAIN ON, AND AFTER SEVERAL ATTEMPTS TO RESTART, WAS REMOVED FROM THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. UPON ANALYSIS OF THE REPORTED DEVICE, PLAQUE CHIPS WERE NOTED TO BE ADHERED TO THE CROWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361456 ↗
• InjuryFeb 19, 2019Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND MID TO DISTAL POSTERIOR TIBIAL (PT) ARTERY. THE LESION IN THE SFA WAS TREATED WITH THE OAD ON LOW AND MEDIUM SPEEDS. THE DEVICE WAS ADVANCED TO THE PT AND THE SECOND LESION WAS TREATED WITH ONE PASS OF THE OAD ON LOW SPEED. WHEN THE DEVICE WAS RETRACTED, IT APPEARED TO BE STUCK TO THE GUIDE WIRE. ANGIOGRAPHY WAS PERFORMED AND NO FLOW IN THE DISTAL PT WAS NOTED. A CATHETER WAS INSERTED AND THREE DOSES OF NITROGLYCERIN WERE ADMINISTERED. A PROLONGED BALLOON INFLATION WITH 2.5 AND 3.0MM BALLOONS WAS ALSO PERFORMED. ANGIOGRAPHY SHOWED A FLOW LIMITING DISSECTION IN THE PT. A STENT WAS PLACED ACROSS A PORTION OF THE DISSECTION AND BALLOON ANGIOPLASTY WAS AGAIN PERFORMED. FOLLOWING THIS INTERVENTION THE DISSECTION WAS RESOLVED AND THERE WAS NO LIMIT TO FLOW. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE AND AT A FOLLOW UP ONE WEEK POST-PROCEDURE.

  Patient problems: No Code Available; Vascular Dissection

  MAUDE report 8350926 ↗
• MalfunctionFeb 1, 2019Material Separation; Material Separation

  THE ORIGINAL EVENT INDICATED THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE BECAME STUCK ON THE VIPERWIRE DURING THE PROCEDURE. THE OAD AND WIRE WERE REMOVED TOGETHER AND THE VESSEL WAS RE-WIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. DEVICE ANALYSIS REVEALED THAT DEVICE FRACTURES HAD ALSO OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8298346 ↗
• InjuryDec 3, 2018Unexpected Shutdown; Unexpected Shutdown

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. DURING TREATMENT OF A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE DEVICE STOPPED SPINNING. UPON REMOVAL OF THE OAD, IMAGING WAS PERFORMED AND A TYPE A DISSECTION WAS NOTED. THE GUIDE WIRE WAS OBSERVED TO BE IN A FALSE LUMEN, AND THE LOCATION WAS CORRECTED. BALLOON ANGIOPLASTY WAS PERFORMED AND AN UNPLANNED STENT WAS PLACED TO RESOLVE THE DISSECTION. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8125965 ↗
• InjuryOct 12, 2018Unexpected Shutdown; Unexpected Shutdown

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO COMPLETE FOUR TREATMENTS ON LOW SPEED. THE EXTENT OF THE CALCIFICATION WAS MODERATE AND THE VESSEL WAS 60% STENOTIC. ONCE THE OAD ADVANCED PAST THE LESION, THE SPEED SETTING WAS INCREASED TO HIGH, AND THE DEVICE STOPPED SPINNING. DESPITE TROUBLESHOOTING, THE DEVICE WOULD NOT START SPINNING AGAIN. THE OAD WAS REMOVED SO THAT IMAGING COULD BE PERFORMED TO ASSESS THE VESSEL. IMAGING SHOWED A DISSECTION WAS PRESENT NEAR THE AREA OF TREATMENT. A BALLOON WAS USED TO SUCCESSFULLY RESOLVE THE DISSECTION. THE PATIENT WAS WELL UPON COMPLETION OF THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7960343 ↗
• MalfunctionJun 29, 2018Device Remains Activated; Device Remains Activated

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED. FOLLOWING ATHERECTOMY TREATMENT, THE OAD WOULD NOT TURN OFF WHEN THE POWER BUTTON WAS PRESSED AND WAS REPEATEDLY POWERING ON AND OFF. THE CASE WAS COMPLETED WITH NO REPORTED COMPLICATIONS AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7650254 ↗
• InjuryJun 5, 2018Device Operational Issue; Device Operational Issue

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION, NO FLOW EVENT, AND VESSEL SPASMS OCCURRED. THE TARGET LESION WAS 95% STENOSED AND LOCATED IN THE TIBULAR-FIBULAR TRUNK. THE LESION WAS TREATED WITH THREE PASSES OF THE OAD ON LOW AND MEDIUM SPEEDS. DURING THE THIRD PASS, THE OAD APPEARED TO STOP SPINNING. THE OAD AND GUIDE WIRE WERE REMOVED AND TISSUE WRAP WAS NOTED ON THE CROWN OF THE OAD. THERE WAS NO FLOW TO THE VESSEL, AND THE LESION WAS RE-WIRED TO PERFORM BALLOON ANGIOPLASTY. SLOW FLOW STILL REMAINED AND MEDICATIONS WERE ADMINISTERED TO TREAT A POSSIBLE THROMBUS. A DISSECTION WAS IDENTIFIED AND VESSEL SPASMS OCCURRED. BALLOON ANGIOPLASTY WAS PERFORMED AGAIN TO RESTORE FLOW AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available; Vascular Dissection

  MAUDE report 7568699 ↗
• InjuryNov 17, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF THE DEVICE BECAME DETACHED. DURING TREATMENT OF A CALCIFIED LESION IN THE SUPERFICIAL FEMORAL ARTERY, THE CSI ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED FUNCTIONING. DURING REMOVAL OF THE DEVICE, THE CROWN WAS NOTED TO HAVE DETACHED. ALL COMPONENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED BY BALLOON ANGIOPLASTY. THE PATIENT CONDITION WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042477 ↗
• InjuryApr 3, 2017Adverse 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, THE PATIENT DEVELOPED A CLOT. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TREATED THE LESION USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD) AT LOW, MEDIUM AND AT HIGH SPEED. POST-ATHERECTOMY DID NOT REVEAL ANY COMPLICATIONS. THE PHYSICIAN FOLLOWED-UP ATHERECTOMY WITH DRUG-COATED BALLOON ANGIOPLASTY AND STENT DEPLOYMENT, BUT A CLOT DEVELOPED AT THIS POINT. AN ANGIOJET CATHETER AND TPA LYRIC CATHETER WERE USED TO REMOVE THE CLOT. IT IS BELIEVED THAT THE PATIENT WAS SUB-THERAPUTIC TO HEPARIN OR HAD AN ANTIBODY TO HEPARIN, BUT IT COULD NOT BE CONFIRMED. IT COULD NOT BE CONFIRMED WHETHER OR NOT THE OAD CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS YET BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6453036 ↗
• InjuryNov 10, 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, THE LATERAL PLANTAR ARTERY SHUT DOWN. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDE WIRE ACROSS THE LESION AND LOADED A CSI ORBITAL ATHERECTOMY DEVICE (OAD) ONTO IT. THE PHYSICIAN COMPLETED ATHERECTOMY, BUT THE PATIENT STARTED TO COMPLAIN OF LEG PAIN. ANGIOGRAPHY REVEALED EMBOLI IN THE LATERAL PLANTAR ARTERY AND THE VESSEL SHUT DOWN. THE PHYSICIAN WAS ABLE TO ASPIRATE THE EMBOLI FROM THE ARTERY AND RESOLVE THE ARTERIAL VESSEL SHUT DOWN. THE PHYSICIAN THEN COMPLETED THE INTERVENTION BY PERFORMING BALLOON ANGIOPLASTY AND STENT DEPLOYMENT IN THE SFA. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Embolus

  MAUDE report 6092599 ↗