Diamondback Coronary DBEC-125MRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10852528005336), received between Oct 2, 2017 and Mar 13, 2018 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A SLOW FLOW EVENT OCCURRED. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OAD APPROACHED THE LESION USING FIVE PASSES ON LOW SPEED, HOWEVER THE DEVICE WAS UNABLE TO CROSS THE LESION. TRANSIENT SLOW FLOW WAS NOTED AND WAS TREATED USING A VASODILATOR. WHEN THE OAD WAS REMOVED IT BECAME STUCK IN THE LESION, AND WAS ABLE TO BE REMOVED WITH NO PATIENT CONSEQUENCES NOTED. THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT AND THE PATIENT WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 7334980 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OCCURRED. THE TARGET LESIONS WERE 70% STENOSED AND LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. AFTER TREATMENT OF THE FIRST LESION, THE DEVICE STOPPED FUNCTIONING AND WAS NOT ABLE TO BE REMOVED FROM THE VESSEL. THE DEVICE WAS SPUN OUT OF THE VESSEL INTO THE GUIDE CATHETER. THE PRESSURE OF THE PATIENT BEGAN TO DROP, AND IMAGING REVEALED A PERFORATION. AN ECHOCARDIOGRAM AND PERICARDIOCENTESIS WERE PERFORMED, AND THE VESSEL WAS RE-WIRED TO PERFORM BALLOON ANGIOPLASTY. AN ATTEMPT WAS MADE TO PLACE A STENT, HOWEVER THE STENT WAS UNABLE TO REACH THE SITE OF THE PERFORATION. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 7114370 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A DISSECTION OCCURRED. THE TARGET LESION WAS 80% STENOSED AND 30 MM IN LENGTH. IT WAS TREATED USING FIVE PASSES WITH THE OAD ON LOW SPEED. UPON REMOVAL OF THE OAD, A DISSECTION WAS IDENTIFIED IN THE MID LOWER ANTERIOR DESCENDING ARTERY. THE DISSECTION WAS PARTIALLY RESOLVED WITH BALLOON ANGIOPLASTY, AND WAS FULLY RESOLVED WITH PLACEMENT OF A STENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 7105922 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND WAS 90% STENOSED. MULTIPLE ATTEMPTS WERE REQUIRED TO ACCESS THE LESION, AND THE OAD WAS NOTED TO JUMP FORWARD AS IT CROSSED THE LESION. THE PATIENT PRESENTED WITH CHEST PAIN, WHICH WAS NOT FULLY RESOLVED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT, AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Chest Pain

  MAUDE report 7054510 ↗
• InjuryNov 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A SLOW FLOW EVENT OCCURRED AFTER USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS TREATED WITH EIGHT RUNS ON LOW SPEED USING THE OAD. WHEN THE OAD WAS REMOVED FROM THE PATIENT, SLOW FLOW WAS NOTED. THE PHYSICIAN RESOLVED THE EVENT BY ADMINISTERING NITROGLYCERIN AND PERFORMING BALLOON ANGIOPLASTY. THE PROCEDURE WAS COMPLETED VIA STENT DEPLOYMENT AND THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Code Available

  MAUDE report 7038504 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A SLOW FLOW EVENT OCCURRED AFTER USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 99% STENOTIC, 12MM IN LENGTH AND WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A WORKHORSE GUIDE WIRE TO ACCESS THE LESION. THE PHYSICIAN EXCHANGED THE WORKHORSE GUIDE WIRE FOR A CSI GUIDE WIRE AND LOADED THE OAD ONTO IT. THE PHYSICIAN PERFORMED FIVE RUNS FOR A TOTAL RUN TIME OF 135 SECONDS. POST-ATHERECTOMY ANGIOGRAPHY REVEALED SLOW FLOW. THE PHYSICIAN RESOLVED THE EVENT AND COMPLETED THE PROCEDURE VIA BALLOON ANGIOPLASTY AND STENT DEPLOYMENT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 6947840 ↗
• InjuryOct 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A SLOW FLOW EVENT OCCURRED AFTER USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 90% STENOTIC, 30MM IN LENGTH AND WAS LOCATED IN THE MID-TO-DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A 7FR INTRODUCER SHEATH AND A WORKHORSE GUIDE WIRE TO ACCESS THE LESION. THE PHYSICIAN EXCHANGED THE WORKHORSE GUIDE WIRE FOR A CSI GUIDE WIRE AND LOADED THE OAD ONTO IT. THE PHYSICIAN PERFORMED TWELVE RUNS AT LOW SPEED FOR A TOTAL RUN TIME OF 300 SECONDS. THE PHYSICIAN THEN PERFORMED FOUR RUNS AT HIGH SPEED FOR A TOTAL RUN TIME OF 85 SECONDS. POST-ATHERECTOMY ANGIOGRAPHY REVEALED SLOW FLOW. THE PHYSICIAN RESOLVED THE EVENT AND COMPLETED THE PROCEDURE VIA BALLOON ANGIOPLASTY AND STENT DEPLOYMENT. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 6907828 ↗
• InjuryOct 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, A PERFORATION OCCURRED WHILE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD). THE TARGET LESION WAS 99% STENOTIC AND WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED AN 8FR INTRODUCER SHEATH, EBU GUIDE CATHETER AND A WORKHORSE GUIDE WIRE TO ACCESS THE LESION. THE PHYSICIAN EXCHANGED THE WORKHORSE GUIDE WIRE FOR A CSI GUIDE WIRE AND LOADED THE OAD ONTO IT. THE PHYSICIAN PERFORMED TEN RUNS AT LOW SPEED FOR 15 SECONDS EACH RUN. THE PHYSICIAN THEN PERFORMED THREE RUNS AT HIGH SPEED FOR 25 SECONDS EACH RUN. POST-ATHERECTOMY ANGIOGRAPHY REVEALED A PERFORATION. THE PHYSICIAN RESOLVED THE EVENT VIA BALLOON ANGIOPLASTY AND THEN PERFORMED PERICARDIOCENTESIS. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE. THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR ANALYSIS.

  Patient problems: Perforation of Vessels

  MAUDE report 6907813 ↗