Dragonfly™ OPTIS™ C408646Recalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 00183739000654), received between Jun 21, 2018 and Jun 5, 2025 — classified as 4 deaths, 60 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (29 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 25 most recent of 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Break; Poor Quality Image; Break; Poor Quality Image

  IT WAS REPORTED THE DRAGONFLY OPSTAR IMAGING CATHETER WAS TO BE USED IN THE PROXIMAL TO MID LEFT CIRCUMFLEX LESION. HOWEVER, THE IMAGE WAS FAULTY. IT WAS ALSO NOTED THE IMAGING CATHETER MAY HAVE FRACTURED BY HITTING THE STENT STRUTS. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND A NON-ABBOTT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152661 ↗
• MalfunctionJun 2, 2025Difficult or Delayed Positioning; Fluid/Blood Leak; Difficult to Advance; Material Split, Cut or Torn; Difficult or Delayed Positioning; Fluid/Blood Leak; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED; THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION WITH RESISTANCE. HOWEVER, THE LENS MARKERS WAS NOT TRACKING ON THE WIRE. ONCE REMOVED, IT WAS NOTED A LEAK FROM A HOLE HALFWAY BETWEEN THE DISTAL AND LENS MARKERS. THEREFORE, THE PROCEDURE COMPLETED WITHOUT USING A REPLACEMENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22127241 ↗
• MalfunctionMay 14, 2025No Display/Image; Poor Quality Image; Material Split, Cut or Torn; No Display/Image; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE INTERVENTRICULAR CORONARY ARTERY WITH NO TORTUOSITY OR CALCIFICATION. DURING USE OF THE DRAGONFLY OPTIS IMAGING CATHETER, AFTER ENTERING THE ANATOMY WHEN TRYING TO CONNECT TO THE ILUMIN OPTIS SYSTEM, AN ARTIFACT IMAGE OCCURRED AND IT WAS NOT POSSIBLE TO DISPLAY AN IMAGE WITHOUT AN ERROR MESSAGE THAT SAID 'PROBE NOT CONNECTED'. AN ATTEMPT WAS MADE TO RESET BY DISCONNECTING AND RECONNECTING THE CATHETER AND ANOTHER ERROR MESSAGE WAS DISPLAYED. A NEW CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THERE WAS A TEAR ON THE WINDOW TUBE AND THE WINDOW TUBE WAS SEPARATED FROM THE BLACK SHEATH BUT HELD TOGETHER BY THE TORQUE WIRE. THE ACCOUNT WAS NOT AWARE OF THE DAMAGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22023059 ↗
• MalfunctionMar 4, 2025No Display/Image; Material Split, Cut or Torn; No Display/Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER DID NOT PROVIDE AN IMAGE PRIOR TO USE. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN ANALYSIS REVEALED THE BLACK SHEATH WAS PUNCTURED AT 19 CENTIMETERS (CM) AND TORN AT 103 AND 112 CM FROM THE PROXIMAL END OF THE OUTER SHELL. NO ADDITIONAL INFORMATION WAS PROVIDED. HOLD I.P 03052025

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518630 ↗
• MalfunctionNov 26, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PREPARATION, THE DRAGONFLY OPTIS IMAGING CATHETER FLUSHING FLUID WAS COMING OUT OF THE CATHETER BODY ABNORMALLY. IT WAS OBSERVED THAT THE IMAGING CATHETER WAS PIERCED (HOLE). THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789507 ↗
• MalfunctionOct 17, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROCEDURE THE DRAGONFLY OPTIS IMAGING CATHETER WAS PREPARED; HOWEVER, THE DEVICE WAS NOT RECOGNIZED BY THE SYSTEM. THE DEVICE WAS DISCONNECTED AND RECONNECTED BUT HAD THE SAME ISSUE. THE PROCEDURE WAS COMPLETED WITHOUT IMAGING. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE CATHETER WAS RETURNED WITH THE SHEATH AND WINDOW TUBE TWISTED, RESULTING IN A TEAR AND TWISTING IN THE WINDOW TUBE MATERIAL AT THE SPLICE REGION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472776 ↗
• MalfunctionAug 22, 2024Fluid/Blood Leak; Poor Quality Image; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn; Fluid/Blood Leak; Poor Quality Image; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS USED IN THE MODERATELY TORTUOSITY, MODERATELY CALCIFIED VESSEL. THERE WAS RESISTANCE FELT WHILE ADVANCING THE CATHETER TO THE LESION. AFTER CROSSING THE LESION, THE IMAGE DISPLAYED WAS BAD (POOR QUALITY IMAGE). THE CATHETER WAS REMOVED AND ANOTHER ATTEMPT VIA FEMORAL ACCESS WAS MADE. HOWEVER, WHILE INJECTING CONTRAST, THERE WAS RESISTANCE FELT WITHIN THE SYRINGE, WHICH CAUSED THE SYRINGE TO BREAK, AND CONTRAST TO LEAK FROM THE SYRINGE. IT WAS NOTED THAT A 20ML SYRINGE WAS USED AGAINST INSTRUCTION FOR USE. ADDITIONALLY, RESISTANCE WAS MET WITH THE GUIDE WIRE AND THE DISTAL PART OF THE CATHETER WAS PERFORATED BY THE GUIDEWIRE. THEREFORE, THE CATHETER WAS REMOVED AND ANOTHER DRAGONFLY OPTIS IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032015 ↗
• MalfunctionJun 17, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT WHEN THE DRAGONFLY OPTIS IMAGING CATHETER DEVICE WAS SELECTED OFF THE SHELF, THE OUTER PACKAGING WAS SEALED; HOWEVER, THE INNER PACKAGING WAS ALREADY OPENED. IT WAS NOTED THAT THE INNER PACKAGE LINING (THE SEAL) WAS PARTLY TORN BACK AND OPENED. THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE CONTINUED WITH AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19548282 ↗
• MalfunctionJun 10, 2024Material Separation; Material Separation

  SUBSEQUENT TO THE INITIAL EMDR REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED DURING USE WITH THE DRAGONFLY OPTIS IMAGING CATHETER, WHILE INSERTING THE GUIDEWIRE INTO THE IMAGING CATHETER, THE DISTAL TIP SEPARATED INTO TWO PIECES. THEREFORE, THE IMAGING CATHETER WAS REMOVED THE PATIENT AND AN UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499409 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED THAT DURING PREPARATION, IT WAS NOTED THAT THE DRAGONFLY IMAGING CATHETER TIP WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460746 ↗
• MalfunctionMay 15, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  SUBSEQUENT TO THE INITIAL MDR REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: AFTER DEVICE ANALYSIS, IT HAS BEEN CONFIRMED THERE WAS NO HOLE ON THE DEVICE OTHER THAN THE EXPECTED PURGE HOLE. THEREFORE, BASED ON THE ANALYSIS, THERE IS NO ISSUE WITH THIS DEVICE AND THIS WOULD NOT BE REPORTABLE, HOWEVER, SINCE A REPORT HAS ALREADY BEEN FILED, THIS WILL REMAIN REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323970 ↗
• MalfunctionApr 11, 2024Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION, THE DRAGONFLY OPTIS IMAGING CATHETER WAS NOT ABLE TO BE FLUSHED. THE IMAGING CATHETER WAS NOT USED IN THE PATIENT AND ANOTHER CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS FOUND THAT THE WINDOW TUBE WAS TORN AT THE PROXIMAL END OF THE CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089786 ↗
• MalfunctionMar 28, 2024Difficult to Remove; Noise, Audible; Difficult to Remove; Noise, Audible

  IT WAS REPORTED THAT NOISE WAS HEARD DURING THE PULLBACK PROCESS OF THE DRAGONFLY CATHETER. ADDITIONALLY, THE CATHETER WAS TAKEN OUT OF THE PATIENT AND IT WAS WRAPPED AROUND THE UNSPECIFIED GUIDE WIRE [RESISTANCE REMOVING]. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ADDITIONAL OCT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990890 ↗
• MalfunctionFeb 28, 2024Improper or Incorrect Procedure or Method; Calibration Problem; Improper or Incorrect Procedure or Method; Calibration Problem

  IT WAS REPORTED THE TWO DRAGONFLY OPTIS IMAGING CATHETERS (9059464 AND 8204330) WERE TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE IMAGING CATHETERS DISPLAYED AN ERROR "CONNECTION FAILURE (395). THE IMAGING CATHETER COULD NOT BE CONNECTED" MESSAGE DISPLAYED PRIOR TO CALIBRATION; THEREFORE, THE IMAGING CATHETERS WERE REMOVED AND THE PROCEDURE COMPLETED WITHOUT USING OCT. IT WAS NOTED THAT THE SECOND IMAGING CATHETER (8204330) WAS USED AFTER THE EXPIRATION DATE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18798462 ↗
• MalfunctionFeb 20, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT MAIN CORONARY ARTERY (LM) AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS PULLED BACK INTO THE CATHETER; HOWEVER, THE DISTAL END OF THE DEVICE WAS STUCK ON THE BALANCED MIDDLE WEIGHT (BMW) GUIDE WIRE (GW), AND THE GUIDE WIRE FELT STICKY WHEN REMOVING. THERE WAS NO DEVICE SEPARATION OR OTHER DAMAGE NOTED. THE DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18743859 ↗
• MalfunctionJan 4, 2024Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED DURING THE PROCEDURE; HOWEVER, WHILE FLUSHING THE CATHETER, CONTRAST FLOWED FROM A HOLE IN THE CATHETER APPROXIMATELY 1.5CM FROM THE TIP. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DRAGONFLY CATHETER. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445482 ↗
• MalfunctionNov 14, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED DURING THE PROCEDURE; HOWEVER, A SMALL OPENING WAS FOUND ON THE INNER PACKAGING, CONTAINING THE CATHETER (LOCATED ON THE AREA USED TO HOLD AND OPEN PACKAGE). THEREFORE, THE CATHETER WAS NOT USED IN THE PATIENT. ANOTHER DRAGONFLY OPTIS IMAGING CATHETER TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18136569 ↗
• MalfunctionNov 8, 2023Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRAGONFLY OPTIS IMAGING CATHETER WAS LEAKING CONTRAST FROM A HOLE AT THE TIP OF THE DEVICE WHILE BEING USED IN THE PATIENT. THE DEVICE WAS REMOVED, AND A NEW DRAGONFLY DEVICE WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093368 ↗
• MalfunctionOct 27, 2023Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER, COULD NOT BE INSERTED ONTO THE GUIDEWIRE. THE IMAGING CATHETER WAS BROKEN. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024801 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OPTIS MOBILE NEXT SYSTEM (ULTREON SOFTWARE) WAS SUCCESSFULLY CONNECTED TO A DRAGONFLY IMAGING CATHETER AND USED IN A DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD CALCIFICATION AND MILD TORTUOSITY. IT WAS NOTED THAT THE PATIENT HAD AN ISCHEMIA CAUSING LESION. REPORTEDLY, THE PHYSICIAN MISUNDERSTOOD WHAT WAS ON THE OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGE DISPLAY DUE TO ONLY HAVING PRIOR EXPERIENCE WITH APTIVIEW SOFTWARE. WHEN USING THE ULTREON SOFTWARE, THE PHYSICIAN THOUGHT THE PORTION OF THE IMAGE ON THE PROXIMAL SIDE (IN THE GUIDE CATHETER) WAS ACTUALLY THE DISTAL PORTION OF THE PULLBACK. AND MISTOOK THIS PART OF THE IMAGE TO BE BLOOD SWIRL. THEREFORE, A SECOND DRAGONFLY IMAGING CATHETER WAS USED. AFTER TWO SUCCESSFUL CONSECUTIVE PULLBACKS, THE PATIENT EXPERIENCED CHEST PAIN POSSIBLY DUE TO INDUCED ISCHEMIA. THE ISCHEMIA WAS POSSIBLY EXACERBATED BY THE USE OF CONTRAST DURING THE OCT PROCEDURE, BUT THIS COULD NOT BE CONFIRMED. THIS RESULTED IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS TREATED WITH FENTANYL, ENDING THE PROCEDURE. A SYSTEM ISSUE WAS INITIALLY SUSPECTED AND A FIELD SERVICE WAS REQUESTED BEFOR

  Patient problems: Angina; Ischemia

  MAUDE report 18000063 ↗
• InjuryOct 19, 2023Poor Quality Image; Difficult to Advance; Poor Quality Image; Difficult to Advance

  IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION WITH HEAVY CALCIFICATION. RESISTANCE WAS FELT DURING ADVANCEMENT. A FIRST RUN WAS PERFORMED AND A DISSECTION WAS CONFIRMED IN THE MID DISTAL SEGMENT. THE DISSECTION WAS TREATED WITH A STENT. A SECOND RUN WAS PERFORMED, HOWEVER, THE IMAGES WERE UNCLEAR. THE DOCTOR SUSPECTS FIBER OPTIC DAMAGE CAUSED BY THE CALCIFICATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 17966874 ↗
• InjurySep 6, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED OPTICAL COHERENCE TOMOGRAPHY WAS TO BE PERFORMED IN THE DISTAL LEFT ANTERIOR DESCENDING AREA, BEHIND AN IMPLANTED STENT. WHEN THE DRAGONFLY IMAGING CATHETER WAS PUSHED THROUGH THE IMPLANTED DISTAL STENT, THE DRAGONFLY GOT STUCK IN THE STENT, WAS DIFFICULT TO REMOVE AND CAUSED A DISSECTION. THE DISSECTION WAS TREATED WITH TWO STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 17693969 ↗
• MalfunctionAug 23, 2023Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE DRAGONFLY CATHETER WAS STUCK IN THE GUIDE CATHETER. THE CATHETER COULD NOT BE DELIVERED TO THE DISTAL VESSEL BECAUSE RESISTANCE WITH THE GUIDE CATHETER WAS FELT DURING ADVANCEMENT AND RESISTANCE WITH THE GUIDE CATHETER WAS FELT WHEN ATTEMPTING TO REMOVE THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH INTRAVASCULAR ULTRASOUND (IVUS). THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608095 ↗
• MalfunctionAug 15, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION (PCI) OCT RUN, WHEN THE PHYSICIAN REMOVED THE DRAGONFLY CATHETER, IT WAS BOUND TO THE RUNTHROUGH WIRE AND BOTH THE OCT CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER. IT WAS NOTED THAT THE GUIDE WIRE APPEARED TO HAVE GOTTEN KINKED FROM THE OCT CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548382 ↗
• MalfunctionAug 7, 2023Defective Device; Defective Device

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER IS APPARENTLY TOO LONG COMPARED TO OTHER PROBES. THE DISTANCE BETWEEN THE MARKERS DO NOT COMPLY WITH THE OFFICIAL TECHNICAL SHEET. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17470604 ↗