Dragonfly OpStar™ 1014651Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 05415067031129), received between Mar 17, 2021 and Sep 24, 2026 — classified as 10 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (47 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 30, 2022Open, Classified

   There is a potential that the proximal marker may separate from the imaging catheter

   Z-1095-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Difficult to Remove; Activation Failure

  It was reported the Dragonfly Opstar Imaging Catheter image was stuck on the guidewire and pullback was unsuccessful. The Catheter and guidewire were removed as a single unit. Another 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 50888536 ↗
• MalfunctionMay 8, 2026No Display/Image; Vibration; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPSTAR IMAGING CATHETER WAS CONNECTED, THE CATHETER VIBRATED AND COULD NOT IMAGE. THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURN ANALYSIS REVEALED THE DISTAL END OF THE WINDOW TUBE WAS TORN APPROXIMATELY 2.5 CENTIMETERS LONGITUDINALLY, PROXIMAL TO THE DISTAL TIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126182 ↗
• MalfunctionMay 7, 2026Material Separation

  IT WAS REPORTED THAT THE END OF THE DRAGONFLY OPSTAR¿ IMAGING CATHETER BROKE. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER UNKNOWN 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 25117055 ↗
• MalfunctionApr 30, 2026Insufficient Device Problem Information; Material Split, Cut or Torn

  THE DRAGONFLY OPSTAR IMAGING CATHETER WAS RETURNED WITH NO REPORTED INFORMATION. THIS DEVICE WAS RETURNED WITH A LONGITUDINAL TEAR IN THE GUIDEWIRE EXIT NOTCH. 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 25050473 ↗
• MalfunctionMar 26, 2026Difficult to Remove

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND HEAVILY TORTUOUS LESION IN THE CIRCUMFLEX ARTERY. THE DRAGONFLY IMAGING CATHETER WAS USED WITH THE WHISPER GUIDEWIRE, AND ADVANCED INTO THE GUIDING CATHETER WITH AN ADDITIONAL GUIDE WIRE. AFTER BEING SUCCESSFULLY USED FOR IMAGING, DURING REMOVAL OF THE DRAGONFLY, THE CATHETER BECAME ENTANGLED WITH THE GUIDE WIRES. 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 24700827 ↗
• InjuryJan 28, 2026Difficult to Remove; Failure to Advance

  SUBSEQUENT TO THE INITIALLY FILED REPORTS IT SHOULD BE NOTED THAT THE DISSECTION WAS NOTED PRIOR TO THE XIENCE SKYPOINT STENT BEING DEPLOYED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 24203618 ↗
• MalfunctionJan 26, 2026

  DURING PCI [PERCUTANEOUS CORONARY INTERVENTION] PROCEDURE TO LAD [LEFT ANTERIOR DESCENDING] THE OCT CATHETER WAS PREPPED AND THEN ADVANCED OVER THE GUIDEWIRE AND APPEARED TO BE WORKING FINE IN" PULLBACK " MODE. HOWEVER, THE CONSOLE GAVE A CATHETER FAILURE ERROR. BOTH ABBOTT REP AND DR. [REDACTED] ATTEMPTED TO DISCONNECT AND RECONNECT THE CATHETER. THE OCT CATHETER WAS REMOVED, AND A NEW OCT WAS USED. NO PT. HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177068 ↗
• MalfunctionJan 19, 2026Difficult to Remove; Difficult to Advance; Material Twisted/Bent

  REPORTEDLY, THE DRAGONFLY OPSTAR IMAGING CATHETER WAS SUCCESSFULLY USED DURING THE PROCEDURE WITH RESISTANCE FELT DURING ADVANCEMENT. DURING REMOVAL, THE CATHETER WAS FOUND BECAME TWISTED AND ENTANGLED IN THE GUIDEWIRE. ANOTHER DRAGONFLY 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 24109159 ↗
• MalfunctionJan 12, 2026No Display/Image; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPSTAR IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THERE WAS LENS DAMAGE, AND A KINK WAS NOTICED. AN ERROR MESSAGE "MANUALLY UNLOAD THE CATHETER" WAS DISPLAYED. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND ANOTHER DRAGONFLY OPSTAR 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. RETURNED DEVICE ANALYSIS FOUND THERE WAS A LONGITUDINAL TEAR IN THE CATHETER DISTAL TIP FROM THE EXIT NOTCH TO THE DISTAL TIP. THE DISTAL SHEATH MARKER WAS NOT PRESENT. THE DISTAL TIP WAS FRAYED AND TORN. THE TIP OF THE CATHETER, INCLUDING THE DISTAL SHEATH MARKER, WAS SEPARATED FROM THE MAIN BODY OF THE CATHETER. THE SEPARATED COMPONENTS WERE NOT RETURNED. THE ACCOUNT CONFIRMED THE TEAR WAS NOTED DURING THE PROCEDURE AS THE GUIDE WIRE GOT SNATCHED DURING THE POST PULL BACK AND WHILE SEPARATING THE WIRE, THE DISTAL PART GOT TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039825 ↗
• MalfunctionJan 6, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN ATTEMPTING TO REMOVE THE UNSPECIFIED OPTICAL COHERENCE TOMOGRAPHY (OCT) CATHETER RESISTANCE WAS MET WITH THE HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE. THE GUIDE WIRE SPIRALED AND BECAME STUCK. THE GUIDE WIRE WAS REMOVED INDEPENDENTLY. AN UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. SUBSEQUENT TO THE INITIALLY FILED REPORTS, ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE GUIDE WIRE WAS RETURNED FROZEN INSIDE THE GUIDE WIRE LUMEN OF A DRAGONFLY CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973067 ↗
• MalfunctionDec 29, 2025Material Separation; Failure to Advance; Material Separation; Failure to Advance

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO RESISTANCE DURING REMOVAL OF THE DRAGONFLY OPSTAR CATHETER FROM THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23915482 ↗
• MalfunctionDec 29, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED DURING PREPARATION WITH THE DRAGONFLY OPSTAR IMAGING CATHETER, AN ERROR "MANUALLY UNLOAD THE CATHETER CONTINUED BY 3 STEPS" MESSAGE DISPLAYED. THEREFORE, THE IMAGING CATHETER WAS NOT USED IN THE PATIENT AND ANOTHER DRAGONFLY OPSTAR IMAGING CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE GUIDEWIRE EXIT NOTCH WAS TORN FOR A LENGTH OF APPROXIMATELY 2MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908989 ↗
• MalfunctionDec 19, 2025Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  REPORTEDLY, TWO DRAGONFLY OPSTAR IMAGING CATHETERS (10806775) WERE USED DURING THE PROCEDURE. THE FIRST CATHETER WAS SELECTED FOR USE, HOWEVER, THERE WAS RESISTANCE FELT DURING ADVANCEMENT, AND THE PROXIMAL END OF THE CATHETER BECAME SEPARATED. THEREFORE, THE IMAGING CATHETER WAS REMOVED AND THE PROCEDURE CONTINUED WITH THE SECOND CATHETER. THE SECOND CATHETER WAS SELECTED FOR USE, HOWEVER, THE CATHETER FAILED TO CONNECT TO THE SYSTEM. AN ERROR MESSAGE "THE DRAGONFLY IMAGING CATHETER CAN¿T CONNECT, ERROR 124" WAS DISPLAYED. THEREFORE, THE CATHETER WAS REMOVED AND A THIRD DRAGONFLY 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 23849350 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 85% STENOSIS. THE DRAGONFLY OPTIS IMAGING WAS ADVANCED WITHOUT RESISTANCE BUT THE PUSH ROD OF THE PROXIMAL SECTION OF THE CATHETER BROKE REMAINING IN ONE PIECE. THERE WAS NO RESISTANCE DURING REMOVAL. ANOTHER DRAGONFLY OPTIS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848698 ↗
• MalfunctionDec 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE FIRST OBTUSE MARGINAL (OM1) AND LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERIES WITH 85-95% STENOSIS AND CALCIFICATION. LEFT RADIAL ACCESS WAS GAINED AND A 6FR 4.5 GUIDE CATHETER WAS ADVANCED AND SEATED COAXIALLY IN THE OSTIUM OF THE LEFT MAIN (LM). THE BLANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WAS INSERTED AND ADVANCED WITHOUT DIFFICULTY TO THE DISTAL OM1. A 2.5X15 MM TREK BALLOON WAS USED FOR PRE-DILATATION AND THE DRAGONFLY OPSTAR IMAGING CATHETER WAS ADVANCED. ONE RUN WAS SUCCESSFULLY IMAGED. UPON REMOVAL OF THE DRAGONFLY, THERE WAS A LOT OF RESISTANCE. THE GUIDE WIRE AND DRAGONFLY HAD TO BE REMOVED TOGETHER AS A UNIT. ONCE OUTSIDE THE ANATOMY, THE WIRE WAS FOUND TO BE FRAYED AND COILED LIKE A RIBBON. THE ANATOMY WAS IMAGED AGAIN WITH FLUORO AND A PIECE OF WIRE WAS SEEN IN THE VESSEL. A SNARE WAS UNSUCCESSFUL. A 2.75X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ATTEMPTED TO BE ADVANCED TO EMBED THE WIRE PIECE INTO THE VESSEL WALL; HOWEVER, IT COULD NOT CROSS. A 2.5 MM TREK BALLOON WAS ULTIMATELY USED TO TACK THE WIRE PIECE TO THE VESSEL WALL AND A NON-ABBOTT STENT WAS IMPLANTED. A FINAL OCT RUN WAS PERFORMED WITH A NEW DR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844697 ↗
• InjuryDec 15, 2025Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE DRAGONFLY OPSTAR IMAGING CATHETER WAS INTENDED TO BE USED IN A MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA) LESION. THE IMAGING CATHETER MET RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND WAS NOT TRACKING RIGHT. THEREFORE, THE CATHETER WAS REMOVED, HOWEVER DURING REMOVAL RESISTANCE WAS FELT WITH THE TORTUOUS LESION AND PRECARIOUS GUIDE AND GUIDE LINER ENGAGEMENT. ONCE REMOVED IT WAS NOTED THAT A MAKER WAS MISSING. ANGIOGRAM WAS PERFORMED AND FOUND THAT A MARKER REMAINED FREE FLOATING IN THE PATIENT DISTAL PDA, INTERVENTION WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23805086 ↗
• MalfunctionNov 25, 2025Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method; Difficult to Remove; Material Separation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE DRAGONFLY OPSTAR IMAGING CATHETER WAS TO BE USED IN THE RIGHT CORONARY ARTERY (RCA). HOWEVER, THE IMAGING CATHETER BECAME STUCK ON THE NON-ABBOTT GUIDEWIRE. FORCE WAS APPLIED TO REMOVE THE IMAGING CATHETER OFF THE GUIDEWIRE AND THE TIP OF THE IMAGING CATHETER SEPARATED AND REMAINED ON THE GUIDEWIRE. BOTH WERE REMOVED IN ONE PIECE. 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 23651221 ↗
• MalfunctionNov 21, 2025No Display/Image; Deformation Due to Compressive Stress; Material Split, Cut or Torn; No Display/Image; Deformation Due to Compressive Stress; Material Split, Cut or Torn

  REPORTEDLY, THE DRAGONFLY IMAGING CATHETER WAS USED DURING THE PROCEDURE. DURING ADVANCEMENT, THE TIP OF THE CATHETER BECAME KINKED, AND THERE WAS NO IMAGE DISPLAYED. THEREFORE, THE CATHETER WAS REMOVED AND ANOTHER DRAGONFLY 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. RETURNED GOODS DEVICE ANALYSIS OBSERVED A TORN GUIDE WIRE EXIT NOTCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617122 ↗
• MalfunctionNov 18, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE OBTUSE MARGINAL (OM). A DRAGONFLY OPSTAR IMAGING CATHETER WAS PREPARED AND CONNECTED TO THE SYSTEM. IMMEDIATELY, AN ERROR MESSAGE WAS DISPLAYED INDICATING A CATHETER ERROR AND PROMPTING RECONNECTION. A RECONNECTION WAS ATTEMPTED; HOWEVER, IT WAS UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOR DRAGONFLY OPSTAR FOUND MULTIPLE TEARS AND CUTS IN THE BLACK SHEATH THAT EXPOSED THE CORE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585915 ↗
• MalfunctionNov 14, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THAT THE DISTAL TIP OF THE DRAGONFLY OPSTAR CATHETER GOT STUCK ON THE NON-ABBOTT 014 GUIDE WIRE AFTER PULLBACK. THE DEVICE WERE PULLED OUT OF THE PATIENT AS ONE DEVICE. OUTSIDE THE PATIENT ANATOMY, IT WAS NOTED THAT THE BLUE TIP HAD SEPARATED AND REMAINED ON THE GUIDE WIRE. THERE WAS NOTHING LEFT IN THE PATIENT ANATOMY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A STENT IMPLANT. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23559334 ↗
• MalfunctionNov 5, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE HI-TORQUE (HT) POWERTURN GUIDEWIRE WAS ADVANCED TO THE RCA AND A DRAGONFLY OPSTAR IMAGING CATHETER WAS USED TO IMAGE THE RCA. AFTER OBTAINING THE IMAGE, THE CATHETER HAD RESISTANCE DURING REMOVAL FROM THE GUIDEWIRE SO BOTH DEVICES WERE REMOVED AS A SINGLE UNIT. THE GUIDEWIRE WAS NOTED TO HAVE SEPARATED AT THE DISTAL END AND THE RADIOPAQUE PORTION OF THE WIRE HAD BEEN SHEARED OFF. FLUOROSCOPY CONFIRMED NOTHING REMAINED IN THE PATIENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482005 ↗
• MalfunctionOct 15, 2025Material Too Soft/Flexible; Material Split, Cut or Torn; Material Too Soft/Flexible; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE DRAGONFLY CATHETER WAS ADVANCED TO THE DISTAL LESION; HOWEVER, IT COULD NOT CROSS THE LESION DUE TO NOT ENOUGH SUPPORT TO PUSH FORWARD. UNDER FLUOROSCOPY, IT WAS NOTED THAT THE GUIDE WIRE WAS DAMAGING THE RAPID EXCHANGE PORT ON THE CATHETER, BY DIGGING INTO IT AND CAUSING IT TO TEAR. THE USE OF THE CATHETER WAS ABORTED AND THE PROCEDURE WAS COMPLETED AT THAT POINT. 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 23285020 ↗
• MalfunctionSep 23, 2025Poor Quality Image; Difficult to Remove; Component Misassembled; Poor Quality Image; Difficult to Remove; Component Misassembled

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE HEAVILY TORTUOUS AND MODERATELY CALCIFIED DE NOVO LESION IN THE LEFT CIRCUMFLEX ARTERY. THE DRAGONFLY CATHETER WAS BEING USED; HOWEVER, THE IMAGE WAS NOT CLEAR. RESISTANCE WITH THE ANATOMY WAS FELT WHEN REMOVING THE CATHETER FROM THE PATIENT ANATOMY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DEPLOYMENT OF AN UNSPECIFIED DRUG ELUTING STENT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE DEVICE RETURN ANALYSIS IDENTIFIED THAT THE PROXIMAL MARKER BAND WAS SHIFTED DISTALLY APPROXIMATELY 1 MILLIMETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23127300 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT THE DRAGONFLY OPSTAR IMAGING CATHETER WAS INTENDED TO BE USED IN AN UNSPECIFIED LESION. HOWEVER, UPON PULLBACK A FRACTURE (BREAK) OCCURRED. THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY. 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 23088318 ↗
• InjuryJul 8, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED THE DRAGONFLY DEVICE WAS SUCCESSFULLY USED DURING PRE-PERCUTANEOUS CORONARY INTERVENTION (PCI). DURING REMOVAL, THE CATHETER'S DISTAL AND LENS MARKERS WERE FOUND TO HAVE SEPARATED FROM THE OUTER BODY OF THE CATHETER. THE PHYSICIAN BUDDY WIRED THE RIGHT CORONARY ARTERY, AND A BALLOON WAS DELIVERED TO THE LESION AND INFLATED TO REMOVE THE REMAINING PART OF THE CATHETER FROM THE PATIENT'S ANATOMY. THERE WAS A 15-MINUTE DELAY IN THE PROCEDURE, HOWEVER, THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440790 ↗