Lantern Delivery Catheter PXSLIMLAN135T45Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00814548016658), received between Jan 30, 2016 and Aug 6, 2026 — classified as 2 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (99 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159135 ↗
• MalfunctionJun 11, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), PENUMBRA COILS AND A NON-PENUMBRA CATHETER (5FR). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. WHILE ADVANCING THE LANTERN TOWARD THE TARGET LOCATION, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE LANTERN FRACTURED AT THE MID-SHAFT WITHIN THE DISTAL TARGET ARTERY. A GUIDEWIRE WAS ADVANCED THROUGH THE FRACTURED SEGMENT, AND BOTH THE GUIDEWIRE AND THE FRACTURED LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN AND FOUR COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25480419 ↗
• MalfunctionApr 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE PULMONARY VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE RETRACTING THE LANTERN UNDER FLUOROSCOPY FOR REPOSITIONING, THE PHYSICIAN OBSERVED THAT THE CATHETER WAS FRACTURED. IT WAS REPORTED THAT THE LANTERN REMAINED SUFFICIENTLY INTACT TO ALLOW REMOVAL BY HAND. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900197 ↗
• MalfunctionSep 16, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A RUBY COIL, AND A COIL (UNKNOWN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE RUBY COIL BECAME STUCK WITHIN THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW COIL THROUGH THE LANTERN; HOWEVER, IT BECAME STUCK IN THE SAME LOCATION AND COULD NOT BE ADVANCED FURTHER. THEREFORE, THE LANTERN AND THE COIL WERE REMOVED. UPON REMOVAL, IT WAS FOUND THAT THE PROXIMAL LENGTH OF THE LANTERN WAS FRACTURED AND THE FRACTURED PIECE WAS REMOVED BY HAND. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069466 ↗
• MalfunctionApr 30, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, POD PACKING COILS (PACKING COILS) AND A GUIDING SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A TOTAL OF FOUR RUBY COILS AND PACKING COILS IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN DECIDED TO RETRACT THE LANTERN TO PERFORM ANGIOGRAPHY AND, WHILE RETRACTING THE LANTERN, FELT THAT IT HAD BECOME DAMAGED. AFTER REMOVING THE LANTERN FROM THE PATIENT, THE LANTERN WAS FOUND TO BE FRACTURED NEAR THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER AND THE SAME GUIDING SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21939681 ↗
• MalfunctionFeb 11, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDING SHEATH, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE REMOVING THE LANTERN TO PERFORM AN ANGIOGRAPHY, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER REMOVAL, THE PHYSICIAN INSPECTED THE LANTERN AND FOUND THAT THE LANTERN HAD FRACTURED AT THE MID-SHAFT. THEREFORE, THE SHEATH AND ANGIOGRAPHIC CATHETER CONTAINING THE FRACTURED SEGMENT OF THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, NON-PENUMBRA COILS, AND THE SAME SHEATH AND ANGIOGRAPHIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21360721 ↗
• MalfunctionMay 8, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDE CATHETER, A NON-PENUMBRA CATHETER, A STENT, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS HIGHLY TORTUOUS. DURING THE PROCEDURE, USING THE IPSILATERAL APPROACH, THE PHYSICIAN ADVANCED THE GUIDE CATHETER, LANTERN, AND GUIDEWIRE TO THE SUPERIOR GLUTEAL ARTERY (SGA). THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE LANTERN TO THE TARGET VESSEL. HOWEVER, THE PHYSICIAN DETERMINED THAT IT WOULD BE DIFFICULT TO APPROACH THE TARGET VESSEL AND DECIDED TO REMOVE THE LANTERN IN ORDER TO ACCESS THE TARGET VESSEL THROUGH THE UPPER ARM. WHILE REMOVING, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE MID-SHAFT OF THE LANTERN FRACTURED. THEREFORE, THE GUIDE CATHETER CONTAINING THE LANTERN WAS REMOVED. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE GUIDE CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271450 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC ARTERY USING A SECOND LANTERN AND LP COILS. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE LANTERN THROUGH THE TORTUOUS VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO CROSS AN AREA. IT WAS REPORTED THAT THERE WAS A VASOSPASM AT THE AREA OF THE VESSEL. THE LANTERN WAS THEN EXCHANGED FOR A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN ADMINISTERED NITROGLYCERIN AND THE VASOSPASM WAS CONSIDERED RESOLVED. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER, RUBY COIL LPS, AND PACKING COIL LPS.

  Patient problems: Vasoconstriction

  MAUDE report 19149235 ↗
• MalfunctionMar 26, 2024Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PERONEAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GLIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE INITIALLY ADVANCING THE LANTERN OVER THE WIRE AND INTO THE GLIDE CATHETER, THE PHYSICIAN KINKED THEN FRACTURED THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED TO A SECOND LANTERN. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, AND THE SAME GUIDE CATHETER AND GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984243 ↗
• MalfunctionFeb 8, 2024Fracture; Leak/Splash; Physical Resistance/Sticking; Fracture; Leak/Splash; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN TWO BRANCHES OF THE PERFUNDA ARTERY USING LANTERN DELIVERY MICROCATHETERS (LANTERN), A RUBY COIL, A POD PACKING COIL (POD PC), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A LANTERN TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN NOTICED THE LANTERN TO BE FRACTURED AND BLOOD LEAKING NEAR THE HUB. THEREFORE, THE LANTERN WAS REMOVED FROM THE PATIENT¿S BODY. THE SAME ISSUE OCCURRED WITH A SECOND LANTERN. THE PHYSICIAN WAS ABLE TO ADVANCE A THIRD LANTERN TO THE TARGET LOCATION. WHILE ATTEMPTING TO ADVANCE A RUBY COIL THROUGH THE THIRD LANTERN, THE PHYSICIAN KINKED THE PUSHER WIRE OF THE RUBY COIL. THE INNER WIRE OF THE RUBY COIL WAS EXPOSED AND THEREFORE, THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT A COMBINATION OF SIXTEEN RUBY COILS AND POD PACKING COILS. WHILE ATTEMPTING TO ADVANCE THE NEXT POD PC THROUGH THE LANTERN, THE PHYSICIAN MET RESISTANCE. SUBSEQUENTLY, THE PUSHER WIRE OF THE POD PC BECAME KINKED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673486 ↗
• MalfunctionFeb 2, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A RUBY COIL, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND LANTERN. UPON REMOVAL OF THE RUBY COIL AND LANTERN, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE LANTERN WAS FRACTURED. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING THE SAME RUBY COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636338 ↗
• MalfunctionSep 8, 2023Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDING CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN APPROXIMATELY FIFTY TO SIXTY CENTIMETERS INTO THE GUIDING CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE LANTERN WAS REMOVED. ON THE BACK TABLE, THE PHYSICIAN FOUND THAT THE PROXIMAL END OF THE LANTERN WAS FRACTURED, AND THE DISTAL END WAS OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715745 ↗
• MalfunctionSep 5, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VEIN OFF OF THE RIGHT RENAL AND SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE LANTERN AT THE TARGET LOCATION AND INJECTED CONTRAST THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN NOTICED THAT CONTRAST WAS NOT GOING THROUGH THE LANTERN. THE PHYSICIAN THEN PULLED BACK ON THE LANTERN AND NOTICED THAT THE LANTERN HAD FRACTURED AT THE HUB. UPON FURTHER RETRACTION OF THE LANTERN, IT BROKE INTO TWO SEPARATE PIECES. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE THROUGH THE BROKEN LANTERN AND REMOVED THE LANTERN AND GUIDEWIRE TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17684687 ↗
• MalfunctionJul 31, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (ICA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN INTO THE PATIENT, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT WAS ABLE TO ADVANCE THE LANTERN INTO THE TARGET VESSEL. THE PHYSICIAN THEN ADVANCED THE RUBY COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED FROM THE PATIENT. AFTER REMOVAL, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE LANTERN WAS FRACTURED BUT REMAINED CONNECTED BY THE INNER WIRE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE PREVIOUSLY REMOVED RUBY COIL, AND POD PACKING COILS (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430742 ↗
• MalfunctionJul 24, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY (CIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE CATHETER INTO THE RIGHT INTERNAL ILIAC ARTERY (ICA). WHILE ADVANCING THE LANTERN THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN BECAME STUCK. THE PHYSICIAN DECIDED TO RETRACT THE LANTERN. WHILE RETRACTING THE LANTERN, THE PHYSICIAN FELT AND NOTICED VIA CONTRAST IMAGING THAT THE LANTERN FRACTURED NEAR THE DISTAL END. THEREFORE, THE NON-PENUMBRA CATHETER CONTAINING THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17382928 ↗
• MalfunctionJun 22, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A 5F CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SIX RUBY COILS INTO THE GLUTEAL ARTERIES USING THE LANTERN. NEXT, WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED VIA ANGIOGRAM THAT THE RUBY COIL WAS PROTRUDING FROM THE LANTERN BEFORE REACHING THE DISTAL END. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED. IT WAS REPORTED THAT THE DISTAL END OF THE LANTERN WAS FRACTURED, BUT REMAINED CONNECTED BY AN INNER WIRE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE PREVIOUSLY REMOVED RUBY COIL, AND FIVE POD PACKING COILS (POD PC). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187608 ↗
• MalfunctionJun 22, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDEWIRE AND COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE RETRACTING AND RE-ADVANCING THE LANTERN WITHIN THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN EXPERIENCED RESISTANCE. NEXT, THE PHYSICIAN INJECTED CONTRAST USING A REINFORCED 3CC SYRINGE TO CHECK IF THE VESSEL WAS OCCLUDED, AND NOTICED THE CONTRAST COMING OUT OF THE LANTERN HUB. AFTER REMOVING THE LANTERN, THE PHYSICIAN NOTICED THAT THE MID-SHAFT OF THE LANTERN WAS FRACTURED. IT WAS REPORTED THAT THE RHV WAS OVERTIGHTENED AT THE LOCATION OF THE FRACTURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17186477 ↗
• MalfunctionJun 13, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT OVARIAN VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. NEXT, WHILE ATTEMPTING TO ADVANCE THE LANTERN OVER THE GUIDEWIRE TO REPOSITION THE LANTERN, THE GUIDEWIRE WOULD NOT ADVANCE THROUGH THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE LANTERN WAS KINKED AND FRACTURED AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17118158 ↗
• MalfunctionMay 2, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COIL (POD PC), NON-PENUMBRA SHEATH, AND A ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE ANGIOGRAPHIC CATHETER AT THE TARGET VESSEL AND THEN ADVANCED THE LANTERN THROUGH THE ANGIOGRAPHIC CATHETER. NEXT, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN DECIDED TO PULL APPROXIMATELY A FEW CENTIMETERS BACK ON THE LANTERN. HOWEVER, WHILE RETRACTING THE LANTERN, THE PHYSICIAN NOTICED THE DISTAL RADIOPAQUE MARKER OF THE LANTERN WAS NOT MOVING WHILE PULLING BACK ON THE PROXIMAL END OF THE LANTERN. SUBSEQUENTLY, UPON FURTHER INSPECTION, THE PROXIMAL END OF THE LANTERN OUTSIDE OF THE PATIENT WAS BROKEN INTO TWO SEPARATE PIECES EXPOSING THE PUSHER ASSEMBLY OF THE POD PC. THE PHYSICIAN DETACHED THE POD PC AND THEN SUCCESSFULLY PULLED AND REMOVED THE BROKEN PORTION OF THE LANTERN OUT FROM THE ANGIOGRAPHIC CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, ADDITIONAL RUBY COILS, SAME ANGIOGRAPHIC CATHETER, AND SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854714 ↗
• MalfunctionMay 1, 2023Break; Break

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE VARICOCELE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A DIAGNOSTIC CATHETER. UPON SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PHYSICIAN REMOVED THE LANTERN AND NOTICED THAT IT WAS FRACTURED APPROXIMATELY THIRTY CENTIMETERS FROM THE PROXIMAL END OF THE HUB. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846002 ↗
• MalfunctionApr 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BUTTOCK VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS IN THE TARGET LOCATION AND NOTICED THE LANTERN WAS BROKEN AT THE HUB. THE PHYSICIAN ATTEMPTED TO REMOVE THE LANTERN; HOWEVER, THE LANTERN WAS BREAKING MORE. THEREFORE, THE PHYSICIAN INSERTED A GUIDEWIRE THROUGH THE LANTERN AND THE LANTERN AND GUIDEWIRE WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16778213 ↗
• MalfunctionFeb 17, 2023Unraveled Material; Unraveled Material

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE RETRACTING THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN HAD UNRAVELED IN SEVERAL PLACES. IT WAS REPORTED THAT THE LANTERN WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401548 ↗
• MalfunctionJan 31, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN INTO THE SHEATH, THE PHYSICIAN BROKE THE LANTERN AT THE MIDSHAFT. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274486 ↗
• MalfunctionJan 4, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AORTOPULMONARY COLLATERAL (APC) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, AFTER USING THE LANTERN AND CATHETER FOR SOME TIME, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN TO RE-WIRE THE CATHETER TO SELECT ANOTHER COLLATERAL VESSEL. WHILE REMOVING THE LANTERN, THE PHYSICIAN NOTICED THAT THE MID-SHAFT OF THE LANTERN WAS BROKEN BUT REMAINED CONNECTED BY AN INNER WIRE. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095365 ↗
• MalfunctionNov 21, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PENUMBRA COILS. DURING THE PROCEDURE, THE LANTERN BROKE AFTER PLACING THE LAST COIL. IT WAS REPORTED THAT TWO HALVES OF THE LANTERN WERE CONNECTED AND THE LANTERN WAS REMOVED BY PULLING OUT. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835369 ↗