Diamondback Peripheral DBP–200SOLID145Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10852528005275), received between Dec 15, 2016 and Oct 22, 2020 — classified as 1 death, 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (6 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. 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS OPERATED ON A 30CM SEGMENT OF A HIGHLY STENOSED SUPERFICIAL FEMORAL ARTERY. DURING TREATMENT THE PATIENT MOVED. AN EMBOLISM OCCURRED IN THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES AND ATTEMPTS TO RESOLVE THE EMBOLISM INCLUDING BALLOON ANGIOPLASTY WERE MADE. THE EMBOLISM IN THE AT WAS RESOLVED, HOWEVER THE DISTAL PORTION OF THE PT REMAINED OCCLUDED. THE PATIENT REMAINED STABLE AND WAS REPORTED AS BEING IN OK CONDITION. PER THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE EMBOLISM WAS ORBITAL ATHERECTOMY AND AN EXCESS OF CALCIFIED PARTICULATE.

  Patient problems: Embolism/Embolus

  MAUDE report 10722195 ↗
• InjuryAug 3, 2020Entrapment of Device; Entrapment of Device

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION LOCATED IN A CHRONIC TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY. ACCESS WAS OBTAINED CONTRALATERALLY, THE VESSEL WAS WIRED, AND THE GUIDE WIRE APPEARED TO BE IN THE TRUE LUMEN. DURING THE FIRST TREATMENT PASS THE OAD BECAME STUCK IN THE VESSEL, AND IT WAS CONFIRMED THAT THE OAD HAD BEEN SUBINTIMAL. TROUBLESHOOTING ATTEMPTS WERE MADE, WHICH INCLUDED ADVANCING A GUIDE CATHETER OVER THE DEVICE, ADMINISTERING NITROGLYCERIN AND ADDITIONAL VIPERSLIDE, AND MANUALLY PULLING ON THE DEVICE BUT THEY WERE ALL UNSUCCESSFUL. HOWEVER, THE OAD WAS ABLE TO BE MANEUVERED INTO A BETTER POSITION TO FACILITATE REMOVAL DURING SURGERY. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO UNDERGO SURGERY AND A SMALL INCISION WAS MADE TO REMOVE THE DEVICE. THE PATIENT CONDITION WAS GOOD FOLLOWING THE SURGERY.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 10356628 ↗
• InjuryApr 10, 2020Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  A DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO), LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE OAD WAS INTENTIONALLY OPERATED IN A SUBINTIMAL SECTION OF THE VESSEL, ON LOW SPEED FOR TEN SECONDS. THE DEVICE STOPPED SPINNING, AND THE CROWN OF THE OAD COULD NOT BE MOVED BACKWARDS THROUGH THE INTRODUCER SHEATH. BOTH THE INTRODUCER SHEATH AND OAD WERE FORCEFULLY REMOVED FROM THE CTO. DURING ATTEMPTS TO MOVE THE CROWN BACKWARD THE OAD WAS PULLED, AND THE CROWN FRACTURED OFF. AN ADDITIONAL ACCESS SITE WAS OPENED, AND THE FRAGMENT WAS RETRIEVED WITH THE USE OF A SNARE DEVICE. THE PROCEDURE WAS CONTINUED WITH SUCCESSFUL STENT PLACEMENT IN THE ILIAC VESSEL. THE PATIENT WAS DOING WELL AND ADDITIONAL TREATMENT TO THE CTO IS ANTICIPATED. THE PHYSICIAN BELIEVED HE WOULD BE ABLE TO OPERATE SUCCESSFULLY IN THE SUBINTIMAL REGION OF THE SFA.

  Patient problems: Foreign Body In Patient

  MAUDE report 9948228 ↗
• InjuryFeb 26, 2020Unexpected Shutdown; Unexpected Shutdown

  THE PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING AND LOST POWER IN THE MIDDLE OF THE THIRD TREATMENT PASS ON MEDIUM SPEED. THE SALINE PUMP WENT INTO STANDBY MODE AND ALL LED LIGHTS ON THE OAD TURNED OFF. DESPITE TROUBLESHOOTING THE ISSUE RECURRED. THE OAD WAS REMOVED, AND IMAGING OF THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS PERFORMED, WHICH REVEALED SLOW FLOW. BALLOON ANGIOPLASTY OF THE SFA AND COMMON FEMORAL ARTERY WAS PERFORMED. IMAGING WAS AGAIN PERFORMED AND SHOWED SLOW FLOW IN THE SFA, POPLITEAL, AND TIBIAL ARTERIES. IMAGING ALSO SHOWED EMBOLI IN THE PERONEAL AND POPLITEAL ARTERIES. THE VIPERWIRE GUIDE WIRE WAS REMOVED. AGGRESSIVE BALLOON ANGIOPLASTY WAS PERFORMED IN BOTH TIBIAL VESSELS IN AN ATTEMPT TO RESOLVE THE EMBOLI SEEN IN THAT AREA. IMAGING OF THE TIBIAL ARTERY WAS THEN PERFORMED AND REVEALED COMPLETE OCCLUSION OF THE PT ARTERY. THE COMPLETE OCCLUSION OF THE PT ARTERY WAS LIKELY CAUSED BY A FLOW LIMITING DISSECTION DUE TO A NON-CSI DEVICE SINCE CSI DEVICES WERE NO LONGER BEING USED IN THAT REGION. THE PATIENT WAS ADMITTED TO THE HOSPITAL, HOWEVER NO ADDITIONAL INTERVENTION WAS PERFORMED AND THE PATIENT WAS DISCHARGED.

  Patient problems: Embolism; Vascular System (Circulation), Impaired

  MAUDE report 9757000 ↗
• MalfunctionSep 4, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE WOULD NOT FLUSH PROPERLY AND SALINE WAS NOT REACHING THE END OF THE DEVICE. NO VISIBLE BLOCKAGES WERE NOTED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8959479 ↗
• InjuryApr 2, 2019Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  THE DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING AND BECAME STUCK IN A LESION IN THE ILIAC ARTERY FOLLOWING TWO ATTEMPTS TO SPIN THE OAD INTO THE LESION. THE VESSEL WAS 95% STENOTIC AND THE LESION WAS HIGHLY CALCIFIED. THE OAD WAS EVENTUALLY REMOVED, AND THE DRIVESHAFT WAS FOUND TO BE DISLODGED NEAR THE CROWN. THE CATHETER WAS ADVANCED OVER THE OAD AND WIRE, AND ALL COMPONENTS WERE REMOVED. THE VESSEL WAS THEN RE-WIRED AND STENT DEPLOYED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8475986 ↗
• InjuryOct 26, 2018Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  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 TREATED WITH ONE PASS OF THE OAD ON LOW SPEED. WHEN THE DEVICE WAS OPERATED BACK THROUGH THE LESION, IT BECAME STUCK ON THE GUIDE WIRE. THE CROWN WAS ADVANCE FORWARD AND THE DEVICE WAS TURNED ON IN ATTEMPT TO DETACH FROM THE WIRE, HOWEVER THE DEVICE SHUT OFF. THE GUIDE WIRE AND DEVICE WERE REMOVED FROM THE SHEATH TOGETHER, HOWEVER IT WAS NOTED THAT THE CROWN HAD BECOME DETACHED AND REMAINED IN THE ILIAC. AN ATTEMPT WAS MADE TO SNARE THE CROWN BUT WAS UNSUCCESSFUL. THE CROWN WAS SECURED TO THE VESSEL WALL USING COVERED STENTS AND THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8009376 ↗
• MalfunctionAug 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A CASE WITH A PERIPHERAL DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), A 6FR SHEATH WAS USED IN THE COMMON FEMORAL ARTERY IN A FEMALE PATIENT WITH A TARGET LESION IN THE LEFT ILLIAC ARTERY. THE OAD SHAFT COULD NOT BE ADVANCED INTO THE LESION FROM THE COMMON FEMORAL ARTERY, AND A RADIAL APPROACH WAS USED TO CONTINUE THE PROCEDURE. THE OAD STOPPED SPINNING DURING THE PROCEDURE. DIFFICULTY WAS ENCOUNTERED WHEN REMOVING THE OAD FROM THE PATIENT. A POSSIBLE TYPE A VESSEL DISSECTION WAS NOTED IN THE EXTERNAL ILLIAC VESSEL. THE LESION AND POSSIBLE DISSECTION WERE STENTED, AND THE PROCEDURE WAS COMPLETED WITH A 30-40 MINUTE DELAY DUE TO THE REPORTED ISSUES. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7821921 ↗
• MalfunctionJul 12, 2018Device Remains Activated; Device Remains Activated

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED. THE TARGET LESION WAS 95% STENOSED AND LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TREATED WITH SIX PASSED OF THE OAD ON LOW, MEDIUM AND HIGH SPEEDS. FOLLOWING THE FINAL PASS ON HIGH SPEED, THE DEVICE WOULD NOT TURN OFF WHEN THE POWER BUTTON WAS PRESSED AND CONTINUED TO SPIN. THE POWER BUTTON WAS PRESSED MULTIPLE TIMES, HOWEVER THE DEVICE DID NOT TURN OFF. THE BRAKE MECHANISM WAS LIFTED TO DEACTIVATE THE DEVICE AND THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7683230 ↗
• MalfunctionJul 6, 2018Device Remains Activated; Device Remains Activated

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DEVICE MALFUNCTION OCCURRED. THE PERIPHERAL DEVICE WAS INTERMITTENTLY TURNING ON OUTSIDE OF OPERATOR CONTROL PRIOR TO INSERTION INTO THE PATIENT. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7667039 ↗
• InjuryJun 5, 2018Detachment Of Device Component; Entrapment of Device; Material Separation; Device Damaged by Another Device; Detachment Of Device Component; Entrapment of Device; Material Separation; Device Damaged by Another Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE DEVICE BECAME DETACHED AND CAUGHT ON A STENT. THE TARGET LESION WAS LOCATED IN THE ILIAC AND WAS HIGHLY CALCIFIED. FOLLOWING THE FIRST PASS WITH THE OAD, THE DEVICE BECAME DETACHED AND THE DRIVESHAFT AND GUIDE WIRE BECAME CAUGHT IN A PREVIOUSLY PLACED STENT. ONE PORTION OF THE DEVICE WAS RETRIEVED WITH A SNARE, AND BALLOON ANGIOPLASTY WAS PERFORMED. AN ADDITIONAL PORTION OF THE DETACHED DEVICE ALONG WITH THE REMAINDER OF THE STENT WERE REMOVED SURGICALLY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7568937 ↗
• InjuryMar 29, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION WAS NOTED. THE TARGET LESION WAS 60% STENOSED AND LOCATED IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE LESION WAS TREATED USING ONE PASS WITH THE OAD AT LOW SPEED AND ONE PASS AT MEDIUM SPEED. FOLLOWING THE SECOND PASS WITH THE OAD, A DISSECTION WAS NOTED AND THE OAD BECAME STUCK IN THE PATIENT. SURGERY WAS PERFORMED TO RESOLVE THE DISSECTION AND REMOVE THE OAD, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7383456 ↗
• InjuryMar 29, 2018Entrapment of Device; Entrapment of Device

  DURING A PERIPHERAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), VESSEL SPASMS OCCURRED. THE TARGET LESIONS WERE LOCATED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND THE OSTIAL AND DISTAL ANTERIOR TIBIAL (AT) ARTERY. IT WAS REPORTED THAT THROUGHOUT THE PROCEDURE VESSEL SPASMS OCCURRED. VASODILATORS WERE ADMINISTERED TO RESOLVE THE SPASMS. FOLLOWING TREATMENT WITH THE OAD, THE DEVICE BECAME STUCK ON THE GUIDE WIRE. THE OAD AND GUIDE WIRE WERE REMOVED AND THE LESION WAS REWIRED. BALLOON ANGIOPLASTY WAS PERFORMED AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7382838 ↗
• InjuryMar 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), EMBOLIZATION OCCURRED. FOLLOWING TREATMENT OF TWO LESIONS USING THE OAD, EMBOLIZATION OF PLAQUE PARTICULATE OCCURRED. THREE UNPLANNED STENTS WERE PLACED TO RESOLVE THE ISSUE AND ATHERECTOMY WAS UNABLE TO BE COMPLETED. THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE.

  Patient problems: Embolus

  MAUDE report 7351023 ↗
• DeathFeb 9, 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 AND THE PATIENT LATER EXPIRED. THE INITIAL TARGET LESION WAS TREATED WITH AN OAD AND BALLOON ANGIOPLASTY. THE OAD WAS REMOVED AND A SECOND OAD OF A DIFFERENT SIZE WAS INSERTED IN ORDER TO TREAT A SECOND LESION IN THE LEFT COMMON ILIAC. THE LESION WAS TREATED WITH THE OAD ON LOW SPEED, AND WIRE BIAS WAS NOTED. THE OAD WAS THEN INCREASED TO HIGH SPEED. AFTER TREATMENT WITH THE OAD, THE PRESSURE OF THE PATIENT DECREASED. THE DEVICE WAS REMOVED AND IMAGING REVEALED A PERFORATION OF THE LEFT COMMON ILIAC. BALLOON ANGIOPLASTY WAS PERFORMED AND A STENT WAS PLACED, HOWEVER THE PATIENT REMAINED UNRESPONSIVE. THE PATIENT WAS TRANSFERRED TO SURGERY, HOWEVER DURING THE SURGICAL PROCEDURE THE PATIENT EXPIRED.

  Patient problems: Death; Perforation of Vessels

  MAUDE report 7259097 ↗
• InjuryMay 1, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH (UF/IMPORTER REPORT # (B)(4)) THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A DISSECTION AND NO FLOW EVENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN ADVANCED THE CSI OAD TO THE TREATMENT AREA AND COMPLETED THE INTERVENTION. UPON REMOVAL OF THE DEVICE, THE PHYSICIAN FELT RESISTANCE, BUT WAS ABLE TO REMOVE THE DEVICE. ANGIOGRAPHY IDENTIFIED THAT THERE WAS A DISSECTION AND NO DISTAL FLOW IN THE SFA. THE PHYSICIAN ATTEMPTED TO INTRODUCE A WIRE TO PERFORM BALLOON ANGIOPLASTY, BUT WAS UNABLE TO ADVANCE TO THE SITE OF THE DISSECTION. THE PHYSICIAN USED DOPPLER IN AN ATTEMPT TO IDENTIFY DISTAL PULSES IN THE PATIENT'S RIGHT FOOT, BUT THEY WERE ABSENT. THE PATIENT WAS THEN TRANSPORTED TO SURGERY FOR ADDITIONAL INTERVENTION. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE BUT A RESPONSE HAS NOT YET BEEN RECEIVED.

  Patient problems: No Code Available; Vascular Dissection

  MAUDE report 6534859 ↗
• InjuryFeb 10, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, THE TIP OF A CSI OAD BROKE OFF AND WAS LEFT IN THE PATIENT. THE TARGET LESIONS WERE 20-30 MM IN LENGTH, 70-95% STENOTIC AND LOCATED IN THE LEFT COMMON ILIAC ARTERY (CIA), EXTERNAL ILIAC ARTERY (EIA) AND THE COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN USED A 6FR X 90 CM ANSEL INTRODUCING SHEATH, A 5FR JR4 CROSSING GUIDE WIRE AND MULTIPLE DIFFERENT WIRES TO ACCESS THE LESION. THE PHYSICIAN ADVANCED A CSI VIPERWIRE GUIDE WIRE ACROSS THE LESION AND THE OAD WAS LOADED ONTO IT. THE PHYSICIAN COMPLETED ONE RUN AT LOW AND MEDIUM SPEED AND TWO RUNS ON HIGH SPEED IN THE LEFT CIA. THE PHYSICIAN THEN ADVANCED THE DEVICE DOWN TO THE EIA AND COMPLETED ONE RUN AT LOW SPEED AND CONTINUED TO MOVE TO THE CFA AND COMPLETED ONE RUN AT LOW AND MEDIUM SPEED AND TWO RUNS AT HIGH SPEED. THE PHYSICIAN RETURNED TO THE EIA AND COMPLETED ANOTHER RUN AT MEDIUM AND HIGH SPEED WHEN ANGIOGRAPHY REVEALED THAT THE TIP OF THE OAD BROKE OF IN THE EIA. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE TIP OF THE DEVICE BUT WAS UNSUCCESSFUL. THE PHYSICIAN PERFORMED BALLOON ANGIOPLASTY AND FOLLOWED UP WITH STENT DEPLOYMENT IN ORDER TO PIN THE TIP OF THE DEVICE

  Patient problems: Foreign Body In Patient

  MAUDE report 6323589 ↗
• InjuryDec 15, 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, DISTAL EMBOLIZATION OCCURRED AFTER USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS LOCATED IN THE COMMON FEMORAL ARTERY (CFA). THE PHYSICIAN ACCESSED THE LESION USING A CSI VIPERWIRE GUIDE WIRE. AN ABBOTT DISTAL FILTER DEVICE WAS FIRST ADVANCED OVER THE GUIDE WIRE AND THE OAD WAS THEN LOADED ONTO THE GUIDE WIRE. THE PHYSICIAN SUCCESSFULLY TREATED THE LESION BY PERFORMING MULTIPLE RUNS WITH THE OAD AND LOW, MEDIUM AND AT HIGH SPEED. THE OAD WAS REMOVED FROM THE PATIENT, BUT WHEN REMOVING THE GUIDE WIRE AND FILTER, THE WIRE BROKE. THE WIRE AND FILTER WERE SUCCESSFULLY SNARED, BUT ANGIOGRAPHY REVEALED DISTAL EMBOLIZATION. THE EMBOLI WERE REMOVED VIA AN ASPIRATION CATHETER AND THE PROCEDURE WAS COMPLETED. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE, BUT WAS DENIED BY THE FACILITY.

  Patient problems: Embolus

  MAUDE report 6176803 ↗