Dragonfly™ OPTIS™ C408645Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00183739000647), received between Jan 22, 2021 and Jan 19, 2026 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (17 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 80% STENOSIS. THE DRAGONFLY OPTIS IMAGING CATHETER DID NOT WORK NORMALLY AND DISPLAYED ERROR CODE 395. 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. RETURNED DEVICE ANALYSIS IDENTIFIED A LONGITUDINAL TEAR OBSERVED IN THE WINDOW TUBE REGION OVER A LENGTH OF 2.5 MILLIMETERS DISTALLY FROM THE EXIT NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109181 ↗
• MalfunctionJan 5, 2026Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT CIRCUMFLEX (LCX) LESION. HOWEVER, THE CORRECT IMAGE FAILED TO DISPLAY. THEREFORE, THE IMAGING 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. RETURNED DEVICE ANALYSIS FOUND THE BLACK SHEATH WAS TORN FOR APPROXIMATELY 1.3 CENTIMETERS, 22 CENTIMETERS FROM THE PROXIMAL END OF THE INNER SHELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957637 ↗
• MalfunctionJan 2, 2026Calibration Problem; Material Split, Cut or Torn

  IT WAS REPORTED, THAT DURING THE PROCEDURE THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT CIRCUMFLEX ARTERY (LCX) LESION. HOWEVER, THE IMAGING CATHETER DISPLAYED ERROR CODE 122. 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. BASED ON THE RESULTS OF THE DEVICE ANALYSIS, THE GUIDEWIRE EXCHANGE MINIRAIL WAS TORN APPROXIMATELY 4 MILLIMETERS (MM) DISTALLY FROM THE EXIT NOTCH. TORN MATERIAL HAS THE POTENTIAL TO RESULT IN FOREIGN MATERIAL IN THE PATIENT AND IS REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950422 ↗
• MalfunctionNov 26, 2025Improper or Incorrect Procedure or Method; Air/Gas in Device; Improper or Incorrect Procedure or Method; Air/Gas in Device

  SUBSEQUENT TO THE INITIALLY FILED REPORT, FOLLOW UP WAS RECEIVED THAT THE DEVICE WAS LOADED ONTO THE GUIDE WIRE THAT ENTERED THE PATIENT VESSEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662067 ↗
• MalfunctionJul 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER, TYVEK POUCH WAS NOTED TO BE DAMAGED. THE UPPER LEFT CORNER OF THE POUCH WAS DAMAGED, CAUSING THE STERILITY BREACH. 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 22613637 ↗
• MalfunctionJul 10, 2025Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS. THE DRAGONFLY OPTIS IMAGING CATHETER WAS USED PRIOR TO THE STENT BEING IMPLANTED; HOWEVER, FAILED TO CROSS DUE TO THE ANATOMY POST STENT IMPLANTATION. ANOTHER DRAGONFLY OPTIS CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE GUIDEWIRE EXIT NOTCH WAS STRETCHED AND TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473758 ↗
• MalfunctionJul 8, 2025Contamination /Decontamination Problem; Communication or Transmission Problem; Material Split, Cut or Torn; Contamination /Decontamination Problem; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS UNABLE TO CONNECT TO THE SYSTEM DURING PREPARATION AND THE DEVICE WAS FOUND TO BE CONTAMINATED. AN ERROR MESSAGE "CONNECTION FAILURE" WAS DISPLAYED. ANOTHER DRAGONFLY OPTIS 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. RETURN DEVICE ANALYSIS NOTED THE GUIDE WIRE EXIT NOTCH WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438740 ↗
• MalfunctionJun 30, 2025No Display/Image; Difficult to Remove; Material Separation; No Display/Image; Difficult to Remove; Material Separation

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE RIGHT CORONARY ARTERY (RCA). HOWEVER, THE IMAGING CATHETER FAILED TO IMAGE. THEREFORE, THE IMAGING 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. RETURNED DEVICE ANALYSIS IDENTIFIED THE BLACK SHEATH WAS SEPARATED FROM THE WINDOW TUBE THAT INCLUDES THE DISTAL MARKER BAND AND CATHETER DISTAL TIP. THE ACCOUNT CONFIRMED THE SEPARATION OCCURRED DURING REMOVAL FROM THE Y VALVE WHEN THE CONTRAST AGENT IN THE CATHETER GOT STUCK TO THE VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22366275 ↗
• MalfunctionMay 6, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE IMAGING CATHETER FAILED TO BE RECOGNIZED BY THE SYSTEM. AN ERROR "CONNECTION FAILURE(395)" MESSAGE WAS DISPLAYED. THEREFORE, THE IMAGING 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. RETURNED DEVICE ANALYSIS FOUND THE GUIDE WIRE EXIT NOTCH WAS TORN FOR A LENGTH OF 1MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973703 ↗
• MalfunctionApr 30, 2025Poor Quality Image; Material Split, Cut or Torn; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. HOWEVER, THE IMAGING CATHETER DISPLAYED ABNORMAL IMAGES. 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. RETURNED DEVICE ANALYSIS IDENTIFIED GUIDE WIRE EXIT NOTCH WAS STRETCHED AND TORN DISTALLY FOR 3.5 MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938081 ↗
• MalfunctionMar 11, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION WITHOUT PATIENT INVOLVEMENT, THE DRAGONFLY OPTIS IMAGING CATHETER WAS REMOVED FROM THE CHIPBOARD BOX WHEN IT WAS NOTED THAT THE PLASTIC BAG PACKAGING WAS NOT SEALED, AND THE STERILITY IS BREACHED. A NEW DRAGONFLY OPTIS WAS USED SUCCESSFULLY FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21575369 ↗
• MalfunctionFeb 13, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRAGONFLY OPTIS IMAGING CATHETER DISPLAYED ERROR CODE (395). THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY OPTIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED THE GUIDE WIRE EXIT NOTCH WAS SPORADICALLY STRETCHED, TORN, AND BENT DISTALLY UP TO THE DISTAL MARKER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21376388 ↗
• MalfunctionJan 21, 2025Poor Quality Image; Failure to Advance; Material Split, Cut or Torn; Poor Quality Image; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT CIRCUMFLEX ARTERY (LCX) LESION. HOWEVER, THE IMAGING CATHETER FAILED TO CROSS THE LESION. THE IMAGING CATHETER DISPLAYED POOR IMAGES. THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY OPTIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS FOUND THE WINDOW TUBE AND TORQUEWIRE ASSEMBLY WERE KINKED 159 CENTIMETERS (CM) DISTAL FROM THE PROXIMAL END OF THE INNER SHELL. THERE WAS A HOLE IN THE WINDOW TUBE MATERIAL AT THE NOTED KINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200635 ↗
• MalfunctionJan 2, 2025Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRAGONFLY OPTIS IMAGING CATHETER WAS INTENDED TO BE USED IN THE LEFT CIRCUMFLEX ARTERY (LCX) LESION. HOWEVER, THE IMAGING CATHETER DISPLAYED AN ERROR CODE (395). THEREFORE, THE IMAGING CATHETER WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY OPTIS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS IDENTIFIED A TEAR WAS OBSERVED IN THE EXIT NOTCH. THE ACCOUNT WAS NOT AWARE OF THE TEAR DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21061045 ↗
• MalfunctionDec 17, 2024Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE RIGHT CORONARY ARTERY (RCA) WITH 65% STENOSIS AND MILD TORTUOSITY. THE DRAGONFLY OPTIS IMAGING CATHETER WAS CONNECTED TO THE DOC BUT FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP OF THE CATHETER WAS NOTED TO BE CHAPPED [CUT]. 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 20957973 ↗
• MalfunctionSep 25, 2024Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THE DRAGONFLY OPTIS IMAGING CATHETER WAS TO BE USED IN THE LEFT ANTERIOR DESCENDING (LAD) LESION. HOWEVER, THE IMAGING CATHETER FAILED TO CONNECT. AN ERROR "CONNECTION FAILURE(395)" MESSAGE DISPLAYED. THEREFORE, THE IMAGING 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. BASED ON THE DEVICE ANALYSIS, THE EXIT GUIDEWIRE NOTCH WAS TORN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305198 ↗
• MalfunctionJan 4, 2024Break; Communication or Transmission Problem; Break; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE DRAGONFLY CATHETER COULD NOT CONNECT TO THE SYSTEM. ERROR MESSAGE "THE DEVICE CANNOT BE CONNECTED. REPLACE THE DEVICE" WAS NOTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRAGONFLY CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT THE WINDOW TUB MATERIAL WAS SEPARATED 33CM PROXIMAL TO THE DISTAL TIP BUT REMAINED INTACT TO THE TORQUE WIRE. FOLLOW-UP WITH THE ACCOUNT CONFIRMED THAT THIS DAMAGE WAS NOT OBSERVED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445357 ↗
• MalfunctionJan 3, 2024Poor Quality Image; Material Split, Cut or Torn; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE 80% STENOSED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE DRAGONFLY CATHETER WAS CONNECTED NORMALLY AND A SECOND PULLBACK WAS PERFORMED. HOWEVER, THE DEVICE DID NOT DISPLAY A NORMAL IMAGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRAGONFLY CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THERE WERE MULTIPLE TEARS NOTED THROUGHOUT THE WINDOW TUBE AT APPROXIMATELY 37MM PROXIMAL TO THE DISTAL END. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18437398 ↗
• MalfunctionNov 30, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PREPARATION, BUBBLES WERE OBSERVED AROUND THE PROXIMAL END OF THE THE DRAGONFLY OPTIS IMAGING CATHETER; THEREFORE, AN AIR LEAK WAS SUSPECTED. THE CATHETER WAS NOT USE IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A NEW DRAGONFLY OPTIS IMAGING 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 18241965 ↗
• MalfunctionNov 17, 2023No Display/Image; Material Split, Cut or Torn; No Display/Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DRAGONFLY OPTIS IMAGING CATHETER DISPLAYED NO IMAGE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED GOODS LAB OBSERVED A TEAR ON THE EXIT NOTCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161260 ↗
• MalfunctionOct 9, 2023No Display/Image; Material Separation; No Display/Image; Material Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17898275 ↗
• MalfunctionApr 26, 2023Failure to Advance; Material Split, Cut or Torn; Failure to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY. THE DRAGONFLY OPTIS IMAGING CATHETER WAS USED DURING THE PROCEDURE; HOWEVER, THE DEVICE WAS UNABLE TO CROSS TO THE TARGET LESION. THE DEVICE WAS REMOVED AND REPLACED WITH A SECOND SAME DEVICE TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS NOTED A TEAR IN THE GUIDEWIRE EXIT NOTCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820681 ↗
• MalfunctionApr 26, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO USE, THE SEAL POUCH OF THE DRAGONFLY OPTIS IMAGING CATHETER DEVICE WAS FOUND DAMAGED AND THE STERILITY WAS COMPROMISED. THEREFORE, THE DEVICE WAS NOT USED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DRAGONFLY OPTIS IMAGING 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 16818616 ↗
• MalfunctionNov 16, 2022Communication or Transmission Problem; Material Split, Cut or Torn; Communication or Transmission Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION WHEN CONNECTING THE CATHETER TO THE DOC THE ERROR MESSAGE CAL-001. THEREFORE, THE CATHETER WAS REPLACED A NEW DRAGONFLY OCT CATHETER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO ADVERSE PATIENT EFFECT. BASED ON THE RETURNED DEVICE ANALYSIS, THE GUIDEWIRE EXIT NOTCH WAS TORN FOR A LENGTH OF 4MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15810687 ↗
• MalfunctionNov 3, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT A LEAK OF THE LUMEN JUNCTION WAS FOUND WHEN THE DRAGONFLY CATHETER WAS FLUSHED WITH CONTRAST MEDIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DRAGONFLY OPTIS CATHETER. THERE WAS NO PATIENT INVOLVEMENT. THE RETURN DEVICE ANALYSIS IDENTIFIED THAT THE OUTER SIDES OF THE X-RING RETAINER PROXIMAL SEAL WAS PUSHED UPWARDS AND NO LONGER PERFECTLY ROUND WHILE SEATED INSIDE THE X-RING RETAINER. ONCE THE SEAL WAS REMOVED FROM THE X-RING RETAINER THE SHAPE OF THE SEAL RETURNED TO ITS NORMAL SHAPE (ROUND). THERE WERE SEPARATED PIECES OF THE X-RING RETAINER PROXIMAL SEAL MATERIAL IN THE LOWER LEFT CORNER. THERE WERE STRANDS OF SHREDDED MATERIAL NEXT TO THE MATERIAL SEPARATION NOTED. THE SEAL WAS THEN FLIPPED OVER AND A SPLIT IN THE X-RING RETAINER PROXIMAL SEAL WAS OBSERVED IN THE UPPER LEFT CORNER. THERE WERE STRANDS OF SHREDDED MATERIAL NEXT TO THE SPLIT NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15721251 ↗