Diamondback Coronary DBEC-125 (REF 70058-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 10852528005169), received between Aug 20, 2015 and May 1, 2025 — classified as 43 deaths, 119 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 25 most recent of 173 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN A LESION. THE CLINICAL EVENTS COMMITTEE REVIEWED THE IMAGES AND IDENTIFIED BRADYCARDIA THAT OCCURRED POST-PROCEDURE THAT REQUIRED A PACEMAKER. THE SITE DID NOT REPORT AN ADVERSE EVENT OR MALFUNCTION RELATED TO THE OAD. NO FURTHER INFORMATION IS AVAILABLE. SUBJECT ID: (B)(6).

  Patient problems: Arrhythmia

  MAUDE report 21944810 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF 80% STENOSED, SEVERELY CALCIFIED, 3.5MM DIAMETER LESION IN PROXIMAL RIGHT CORONARY ARTERY (RCA). TWELVE LOW-SPEED TREATMENTS WERE PERFORMED AT THE TARGET LESION. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19949636 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TARGET TREATMENT AREA WAS A 30MM LESION IN 75% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN TWICE ON LOW SPEED AND TWICE ON HIGH SPEED. ANGIOGRAPHIC IMAGING WAS PERFORMED THAT SHOWED NO PROCEDURAL COMPLICATIONS. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19931146 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED, STENOSED, 3MM LEFT CIRCUMFLEX ARTERY. FIVE LOW SPEED TREATMENTS WERE PERFORMED. THERE WERE NO ORBITAL ATHERECTOMY RELATED PATIENT COMPLICATIONS OBSERVED AT THE END OF THE PROCEDURE. THE CLINICAL EVENT COMMITTEE (CEC) CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 19829386 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING PRE-DILATATION, ANGIOGRAPHIC IMAGING OBSERVED SLOW FLOW IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18497519 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING PRE-DILATATION, ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE MID RIGHT CORONARY ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18497471 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A PERFORATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Perforation of Vessels

  MAUDE report 18493530 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18478078 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A DE NOVO, 90% STENOSED, SEVERELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY VIA RIGHT FEMORAL ACCESS. TWO LOW-SPEED TREATMENTS FOLLOWED BY TWO HIGH-SPEED TREATMENTS WERE PERFORMED. A SUCCESSFUL BALLOON ANGIOPLASTY AND STENT PLACEMENT USING NON-CSI PRODUCTS FOLLOWED. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION AND WAS DISCHARGED HOME TWO DAYS LATER. SUBJECT IDENTIFIER: (B)(6).

  Patient problems: Myocardial Infarction

  MAUDE report 18092432 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE PROCEDURE AND POST-PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN. HYDROCODONE-ACETAMINOPHEN WAS ADMINISTERED TO RELIEVE THE CHEST PAIN.

  Patient problems: Chest Pain; Myocardial Infarction; Vascular Dissection

  MAUDE report 17361090 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) PERFORATED THE RIGHT CORONARY DURING ATTEMPTED TREATMENT OF A TYPE C LESION IN THE RIGHT CORONARY ARTERY, WHICH WAS 2.0MM IN DIAMETER AND 99% STENOTIC. COVERED STENTS WERE PLACED TO ADDRESS THE PERFORATION, AND THE PATIENT STABILIZED. THE PATIENT LATER CODED AND EXPIRED DESPITE ADMINISTRATION OF LIFE-SAVING MEASURES. THE OPINION OF THE PHYSICIAN IS THAT THE OAD CAUSED THE PERFORATION BUT DID NOT CAUSE THE PATIENT'S DEATH. THE CAUSE OF DEATH WAS REPORTEDLY OCCLUSION OF THE CONUS AND RIGHT VENTRICULAR ARTERIES DURING STENT PLACEMENT.

  Patient problems: Perforation of Vessels

  MAUDE report 8535388 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CSI WAS NOTIFIED THAT A STUDY CORE LAB REPORTED A VISUAL OBSERVATION OF A DISSECTION TYPE C AFTER USE OF THE ORBITAL ATHERECTOMY DEVICE DURING AN ANGIOGRAPHIC IMAGE REVIEW FOLLOWING THE PROCEDURE. THE FINAL ANGIOGRAPHIC MORPHOLOGY HAD NO OBSERVATION OF DISSECTION WITH A TIMI FLOW OF 3. NO ADVERSE EVENTS OR ANGIOGRAPHIC COMPLICATIONS RELATING TO DISSECTION WERE REPORTED BY THE TREATING PHYSICIAN.

  Patient problems: Vascular Dissection

  MAUDE report 8241392 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI DIAMONDBACK ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY AND WAS TREATED WITH THREE PASSES OF THE OAD ON LOW SPEED. IMAGING WAS PERFORMED FOLLOWING ATHERECTOMY TREATMENT AND A PERFORATION WAS NOTED. THE OAD WAS REMOVED AND BALLOON ANGIOPLASTY WAS PERFORMED. IMAGING PERFORMED FOLLOWING THE ANGIOPLASTY SHOWED THAT THE PERFORATION WAS NOT RESOLVED. FOLLOWING A SURGICAL CONSULT, THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY AND UNDERWENT SURGERY TO RESOLVE THE PERFORATION AND TO PERFORM A BYPASS OF BOTH THE CIRCUMFLEX AND RIGHT CORONARY ARTERY. IT WAS REPORTED THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 8203250 ↗
• DeathNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), NO REFLOW OCCURRED AND THE PATIENT EXPIRED. THE TARGET LESION WAS 90% STENOSED AND LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS TREATED WITH MULTIPLE PASSES OF THE OAD FOLLOWED BY BALLOON ANGIOPLASTY, AND THIS SEQUENCE WAS REPEATED THREE TIMES. FOLLOWING THE THIRD BALLOON INFLATION, ST ELEVATIONS WERE NOTED AND THE PATIENT BECAME UNRESPONSIVE AND NO FLOW WAS NOTED. INSERTION OF A VENTRICULAR ASSIST DEVICE WAS ATTEMPTED HOWEVER IT WAS UNABLE TO BE USED AS THE VALVE WAS TOO NARROW. CHEST COMPRESSIONS WERE PERFORMED AND THE PATIENT APPEARED TO STABILIZE MOMENTARILY, HOWEVER IT WAS REPORTED THAT THE PATIENT THEN EXPIRED.

  Patient problems: Death; No Code Available; ST Segment Elevation

  MAUDE report 8121611 ↗
• InjuryOct 16, 2018Difficult to Remove; Unexpected Shutdown; Difficult to Remove; Unexpected Shutdown

  MEDWATCH (B)(4) WAS RECEIVED BY CSI ON 24 SEPTEMBER 2018 WHICH INDICATED THE FOLLOWING: THE STEALTH CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) BECAME STUCK IN A TYPE C LESION IN THE PROXIMAL RIGHT CORONARY ARTERY FOLLOWING THREE TREATMENTS AT 80,000RPM. THE SPEED WAS INCREASED TO 120,000RPM, BUT FURTHER ATTEMPTS TO REMOVE THE OAD WERE UNSUCCESSFUL. THE DEVICE STOPPED SPINNING AND WAS STILL STUCK IN THE LESION. THE VIPERWIRE AND OAD WERE REMOVED FROM THE PATIENT. A DISSECTION WITH NO FLOW WAS IDENTIFIED. THE PATIENT REPORTEDLY EXPERIENCED VOMITING IN RELATION TO THE EVENT BUT WAS LATER DISCHARGED AND WAS WELL UPON DISCHARGE.

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

  MAUDE report 7971140 ↗
• InjurySep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE CROWN BECAME DETACHED IN THE PATIENT. THE TARGET LESION WAS 95% STENOSED AND LOCATED IN A TORTUOUS REGION OF THE CIRCUMFLEX. THE REGION WAS UNABLE TO BE STENTED. DURING TREATMENT WITH THE OAD, THE CROWN WAS OBSERVED TO BE DETACHED. THE CROWN WAS RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED FOR THIS EVENT, HOWEVER IT WAS REPORTED TO CSI THAT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7918559 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE ADVANCED THROUGH A NARROW LESION IN THE RIGHT CORONARY ARTERY (RCA) VIA FEMORAL APPROACH DESPITE USE OF THE VIPERWIRE TO HELP DIRECT AND DESPITE THE USE OF A THREADER CATHETER. THE DEVICE WAS TURNED ON IN ORDER TO TREAT THE PROXIMAL PART OF THE LESION SO THAT THE DEVICE COULD ADVANCE FARTHER. AFTER TWO TREATMENTS A FLOW-LIMITING DISSECTION WAS IDENTIFIED IN THE RCA. ORBITAL ATHERECTOMY WAS DISCONTINUED AT THAT TIME. RESISTANCE WAS ENCOUNTERED WHEN THE OAD WAS REMOVED. AT THAT TIME, THE DISSECTION WAS NOTED TO BE FLOW-LIMITING. A GUIDE WIRE WOULD NOT CROSS THE DISSECTION, AND A BALLOON WAS USED TO TREAT THE DISSECTION, BUT THE ARTERY DID NOT OPEN. THE PATIENT THEN COMPLAINED OF CHEST PAIN. PERICARDIAL EFFUSION WAS RULED OUT, AND ATTEMPTS TO CROSS THE DISSECTION WITH A GUIDE WIRE WERE CONTINUED. A BALLOON PUMP WAS PLACED AND THE PATIENT NO LONGER HAD CHEST PAIN AND THE PT SEGMENTS BECAME NORMAL. THE PATIENT WAS DISCHARGED (B)(6) 2018.

  Patient problems: Vascular Dissection

  MAUDE report 7885493 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING OPTICAL COHERENCE TOMOGRAPHY IMAGE REVIEW FOLLOWING THE ATHERECTOMY PROCEDURE WITH AN ORBITAL ATHERECTOMY DEVICE, A THROMBUS WAS IDENTIFIED. THE PROCEDURE WAS REPORTEDLY COMPLETED WITHOUT ADVERSE EVENT TO THE PATIENT. CLINICAL STUDY PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7848462 ↗
• MalfunctionAug 29, 2018Fracture; Fracture

  AN ATHERECTOMY PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA) WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). REPORTEDLY, THE RCA WAS EXTREMELY TORTUOUS AND GUIDE WIRE ADVANCEMENT TO THE TARGET LESION WAS DIFFICULT. ADDITIONAL FORCE WAS USED TO ADVANCE THE DEVICE INTO TO THE LESION. ON IMAGING, THE OAD APPEARED TO BEND DISTAL TO THE CROWN, BUT THE PROCEDURE WAS CONTINUED REGARDLESS OF THE BEND. SIX TREATMENTS WERE ADMINISTERED WITH THE OAD. WHEN THE DEVICE WAS WITHDRAWN A SHORT DISTANCE, IMAGING SHOWED THAT THE TIP OF THE OAD HAD DETACHED. THE TIP WAS RETRIEVED VIA ADVANCEMENT OF THE GUIDELINER AND SLOW RETRACTION OF THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. AN ANGIOGRAM WAS PERFORMED TO VERIFY THAT THE PATIENT HAD EXPERIENCED NO ADVERSE EVENTS, AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7828672 ↗
• DeathAug 20, 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 PERFORATION OCCURRED AND THE PATIENT EXPIRED. THREE TARGET LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESIONS WERE TREATED WITH THE OAD, HOWEVER DURING THE FINAL PASS WITH THE DEVICE A PERFORATION OCCURRED. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED, HOWEVER THE CONDITION OF THE PATIENT DECLINED. FOLLOWING RESUSCITATION EFFORTS, THE PATIENT EXPIRED.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 7799114 ↗
• InjuryAug 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THIS WAS IDENTIFIED DURING AN OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS RELATED TO THROMBUS REPORTED.

  Patient problems: Myocardial Infarction; No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7793064 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THIS WAS IDENTIFIED DURING AN OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7768763 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THIS WAS IDENTIFIED DURING AN OPTICAL COHERENCE TOMOGRAPHY IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7758661 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THIS WAS IDENTIFIED DURING AN OPTICAL COHERENCE TOMOGRAPHY IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7758228 ↗
• InjuryAug 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A THROMBUS OCCURRED. THIS WAS IDENTIFIED DURING AN OPTICAL COHERENCE TOMOGRAPHY IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Thrombus

  MAUDE report 7757982 ↗