Lantern Delivery Catheter PXSLIMLAN150T45Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00814548016689), received between Feb 12, 2016 and Aug 27, 2026 — classified as 1 injury, 139 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (55 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 140 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Fracture

  The patient was undergoing a coil embolization procedure in the right peroneal artery using a Lantern Delivery Microcatheter (Lantern) and a glide catheter (4F). While removing the Lantern from the patient, the physician observed that the Lantern fractured at the midshaft within the glide catheter. The fracture was confirmed under fluoroscopy. Aspiration was applied to the glide catheter, and the glide catheter containing the fractured segment of the Lantern was removed from the patient.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 50475665 ↗
• MalfunctionJan 7, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A GUIDE CATHETER, NON-PENUMBRA COILS, MICROSPHERES, A CONTRAST AGENT, SALINE, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED MICROSPHERES, TWO NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE LANTERN. IT WAS ALSO REPORTED THAT CONTRAST AGENT AND SALINE WERE ALSO ADMINISTERED THROUGH THE LANTERN. THE PHYSICIAN THEN NOTICED THAT THE LANTERN WASN¿T PERFORMING AS EXPECTED AND DECIDED TO REMOVE IT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE LANTERN FRACTURED AT ITS DISTAL SEGMENT. THE PROCEDURE WAS COMPLETED USING A PX SLIM DELIVERY MICROCATHETER (PX SLIM). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23995581 ↗
• MalfunctionDec 12, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS RETRACTING THE LANTERN FROM THE DIAGNOSTIC CATHETER TO REPOSITION THE LANTERN AND NOTICED THAT THE LANTERN HAD FRACTURED AT THE MIDSHAFT. THEREFORE, THE DIAGNOSTIC CATHETER CONTAINING THE FRACTURED LANTERN WAS REMOVED TOGETHER OVER THE GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A NEW PX SLIM DELIVERY MICROCATHETER (PX SLIM) AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796504 ↗
• MalfunctionDec 20, 2023Break; Fracture; Physical Resistance/Sticking; Break; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY AND VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), PENUMBRA COILS (RUBY/POD/PACKING), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED APPROXIMATELY FOUR TO FIVE PENUMBRA COILS IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE NEXT PENUMBRA COIL THROUGH THE LANTERN; HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PENUMBRA COIL WOULD NOT ADVANCE THROUGH. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PENUMBRA COIL AND LANTERN. UPON REMOVAL OF THE PENUMBRA COIL AND LANTERN, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE LANTERN WAS UNWOUND. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, PENUMBRA COILS AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361944 ↗
• MalfunctionNov 28, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE COLLATERAL VESSELS USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN INTO THE ANGIOGRAPHIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE LANTERN. HOWEVER, WHILE RETRACTING THE LANTERN THROUGH THE ANGIOGRAPHIC CATHETER, THE MIDSHAFT OF THE LANTERN FRACTURED. THE LANTERN WAS CONTAINED INSIDE THE ANGIOGRAPHIC CATHETER; THEREFORE, THE PHYSICIAN REMOVED THE ANGIOGRAPHIC CATHETER AND LANTERN TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER, THE SAME ANGIOGRAPHIC CATHETER, AND A MICROWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18221087 ↗
• MalfunctionNov 8, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, A SHEATH, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN FRACTURED THE LANTERN WHILE ADVANCING IT THROUGH THE CATHETER. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE FRACTURED LANTERN REMAINED IN ONE PIECE AND WAS CONTAINED WITHIN THE PARENT CATHETER AND SHEATH. THEREFORE, THE LANTERN, CATHETER, AND SHEATH WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, THE SAME CATHETER, 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 18095058 ↗
• MalfunctionSep 11, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT OVARIAN VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A DIAGNOSTIC GUIDE CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD COIL THROUGH THE LANTERN. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED THE POD COIL INTO THE TARGET VESSEL. WHILE RETRACTING THE PUSHER ASSEMBLY OF THE POD COIL, IT FRACTURED WITHIN THE LANTERN AND ONLY A PART OF THE PUSHER ASSEMBLY WAS REMOVED. WITHOUT REALIZING THAT PART OF THE POD COIL PUSHER ASSEMBLY WAS FRACTURED INSIDE THE LANTERN, THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PACKING COIL (POD PC) THROUGH THE LANTERN. HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE PHYSICIAN REMOVED THE POD PC AND THE LANTERN TO CHECK THE SYSTEM. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE LANTERN WAS FRACTURED AT THE DISTAL END. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN TO IMPLANT THE SAME POD PC AND AN ADDITIONAL POD PC, AND THE SAME DIAGNOSTIC GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17726343 ↗
• MalfunctionJun 1, 2023Break; Break

  THE PATIENT UNDERWENT A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE LANTERN APPEARED TO BE FRACTURED. THEREFORE, THE PHYSICIAN SLOWLY REMOVED THE LANTERN AND CONFIRMED THAT IT WAS BROKEN AT THE MID TO DISTAL END. THE PROCEDURE 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 17044895 ↗
• MalfunctionMay 15, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD COIL, AND NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE LANTERN CONTAINING THE POD COIL. WHILE REMOVING, THE PHYSICIAN NOTICED THAT THE LANTERN WAS BROKEN NEAR THE PROXIMAL END. THEREFORE, THE LANTERN AND POD COIL WERE NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, FOUR POD PACKING COILS (POD PCS), AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16936121 ↗
• MalfunctionMay 10, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT LATERAL THORACIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE. THE PHYSICIAN SUCCESSFULLY IMPLANTED THE INITIAL COILS INTO THE FIRST BRANCH OF THE TARGET VESSEL USING THE LANTERN. WHILE RE-ADVANCING THE LANTERN TO SELECT ANOTHER BRANCH, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN WOULD NOT ADVANCE MORE THAN HALFWAY OVER THE GUIDEWIRE. SUBSEQUENTLY, THE PHYSICIAN NOTICED BLOOD LEAKING OUT OF A SMALL CRACK ON THE MID-SHAFT OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME GUIDE CATHETER, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908415 ↗
• MalfunctionDec 2, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDE SHEATH, A NON-PENUMBRA BASE CATHETER, AND A ROTATING HEMOSTASIS VALVE (RHV). DURING THE PROCEDURE, WHILE ATTEMPTING TO REMOVE THE LANTERN FROM THE BASE CATHETER TO REPOSITION THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND UPON REMOVAL, THE LANTERN WAS NOTICED TO BE BROKEN AT THE MID-SHAFT. IT WAS REPORTED THAT THE RHV WAS TOO TIGHT. THE PHYSICIAN REMOVED THE BROKEN HALF OF THE LANTERN BY PULLING THE BASE CATHETER OUT AND FLUSHING IT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME GUIDE CATHETER AND THE SAME BASE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15905594 ↗
• MalfunctionSep 25, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE NON-PENUMBRA MICROCATHETER INTO THE DESIRED LOCATION. NEXT, THE PHYSICIAN REMOVED THE MICROCATHETER AND SWITCHED TO A LANTERN. WHILE ADVANCING THE LANTERN TO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE RADIOPAQUE MARKER OF THE LANTERN WAS NOT MOVING. THEREFORE, THE PHYSICIAN INJECTED CONTRAST THROUGH THE LANTERN AND NOTICED CONTRAST WAS EXITING AROUND THE MIDDLE OF THE LANTERN. SUBSEQUENTLY, THE LANTERN HAD BROKEN INTO TWO SEPARATES PIECES IN THE AVM. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE BROKEN END OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15482076 ↗
• MalfunctionSep 20, 2022Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A HEPATIC ARTERY BLEEDING USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE LANTERN OVER THE GUIDEWIRE TO THE BACK DOOR OF THE TARGET VESSEL, THE LANTERN WENT INTO THE ANEURYSM THAT WAS PREVIOUSLY TREATED WITH CLIPS. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE LANTERN. WHILE ATTEMPTING TO RETRACT THE LANTERN WITH THE GUIDEWIRE, THE PHYSICIAN KINKED AND BROKE THE LANTERN AT THE MID-SHAFT. THE PHYSICIAN WAS THEN ABLE TO REMOVE THE LANTERN WITHOUT FURTHER ISSUES. 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 15455427 ↗
• MalfunctionJul 26, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN COLLATERAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, AFTER INITIALLY ADVANCING THE LANTERN THROUGH THE GUIDE CATHETER, THE PHYSICIAN FRACTURED THE LANTERN MID-SHAFT. THEREFORE, THE LANTERN WAS REMOVED. 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 15108557 ↗
• MalfunctionNov 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT THREE FISTULAS OFF A BYPASS GRAFT USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY EMBOLIZED THE FIRST TWO FISTULAS WITHOUT ISSUE USING THE LANTERN AND TWO POD COILS. WHILE ATTEMPTING TO ADVANCE ANOTHER POD COIL TO THE THIRD FISTULA USING THE LANTERN, THE PHYSICIAN KINKED THE LANTERN NEAR THE HUB PRIOR TO INSERTING THE INTRODUCER SHEATH OF THE POD COIL INTO THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME POD COIL AND TWO RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879940 ↗
• MalfunctionNov 7, 2021Material Puncture/Hole; Difficult to Advance; Material Puncture/Hole; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND A NON-PENUMBRA GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY ADVANCING THE LANTERN OVER THE GUIDEWIRE AND SUBSEQUENTLY, THE GUIDEWIRE WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND GUIDEWIRE. UPON REMOVAL, IT WAS NOTICED THAT THE GUIDEWIRE PERFORATED THE LANTERN AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, TWELVE RUBY COILS AND A NEW NON-PENUMBRA GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763362 ↗
• MalfunctionOct 25, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, NON-PENUMBRA COILS, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS, NARROWED AND MODERATELY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL AS THE FIRST COIL IN THE MID-SHAFT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN RETRACTED AND REMOVED THE RUBY COIL AND FLUSHED THE LANTERN. WHILE RE-ADVANCING THE RUBY COIL THROUGH THE SAME LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN. THEREFORE, THE LANTERN WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED THE RUBY COIL IN THE TARGET VESSEL USING ANOTHER LANTERN. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA COILS AND THE SECOND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692955 ↗
• MalfunctionOct 1, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA PARENT CATHETER . DURING THE PROCEDURE, THE LANTERN BROKE AT THE MIDSHAFT WHILE BEING PULLED FROM THE PARENT CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME PARENT NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565700 ↗
• MalfunctionSep 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, LANTERN DELIVERY MICROCATHETERS (LANTERN), NON-PENUMBRA COILS, AND POD PACKING COILS (POD PC). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN RETRACTED THE RUBY COIL AND FLUSHED IT. SUBSEQUENTLY, WHILE RE-ATTEMPTING TO ADVANCE THE RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AGAIN. THEREFORE, THE RUBY COIL AND THE LANTERN WERE REMOVED TOGETHER. NEXT, WHILE ATTEMPTING TO ADVANCE THE SAME RUBY COIL THROUGH A SECOND LANTERN, THE SAME ISSUE OCCURRED. THEREFORE, THE RUBY COIL AND THE SECOND LANTERN WERE ALSO REMOVED TOGETHER. THE PHYSICIAN THEN SUCCESSFULLY IMPLANTED THE SAME RUBY COIL IN THE TARGET VESSEL USING A THIRD LANTERN. THE PROCEDURE WAS COMPLETED USING THE THIRD LANTERN, TWO ADDITIONAL RUBY COILS, THREE NON-PENUMBRA COILS, AND TWO POD PCS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436558 ↗
• MalfunctionAug 27, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN OVER THE GUIDEWIRE AND INTO THE TARGET VESSEL, THE PHYSICIAN LOST ACCESS AND DECIDED TO REMOVE THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN REPOSITIONED THE GUIDEWIRE AND WHILE ATTEMPTING TO RE-ADVANCE THE SAME LANTERN OVER THE GUIDEWIRE, THE PHYSICIAN NOTICED THE DISTAL TIP OF THE LANTERN HAD BROKEN OFF. IT WAS REPORTED THAT THE DISTAL TIP OF THE LANTERN HAD BROKEN OFF OUTSIDE THE PATIENT AND ON THE STERILE FIELD. THEREFORE, THE LANTERN WAS NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378301 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE BRANCHES OF THE HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD COIL AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE POD COIL THROUGH THE LANTERN, THE POD COIL BECAME STUCK WITHIN THE LANTERN. UPON RETRACTION, THE POD COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT. SUBSEQUENTLY, UPON REMOVAL, THE DISTAL PORTION OF THE LANTERN WAS OBSERVED TO BE KINKED AND OVALIZED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN WITH A STRAIGHT TIP, A NEW POD COIL 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 12271342 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDING SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING A NON-PENUMBRA COIL THROUGH THE MIDDLE OF THE LANTERN TOWARD THE DISTAL TIP, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE LANTERN AND THE NON-PENUMBRA COIL WERE REMOVED. AFTER THE REMOVAL OF THE LANTERN AND THE NON-PENUMBRA COIL, THE PHYSICIAN NOTICED THAT THE DISTAL TIP OF THE LANTERN WAS DENTED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL, NON-PENUMBRA COILS, AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12255176 ↗
• MalfunctionJul 2, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE LANTERN BROKE PROXIMALLY BY THE HUB WHEN BEING ADVANCED THROUGH THE CATHETER. THEREFORE, THE LANTERN WAS REMOVED. 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 12110937 ↗
• MalfunctionMay 24, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, POD PACKING COILS (POD PCS), AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD COIL; HOWEVER, THE POD COIL WAS SUCCESSFULLY IMPLANTED. NEXT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD PC THROUGH THE MIDDLE OF THE LANTERN. THEREFORE, THE POD PC AND LANTERN WERE REMOVED FROM THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN TO IMPLANT THE SAME POD PC, ONE ADDITIONAL POD PC OF THE SAME SIZE, AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871483 ↗
• MalfunctionMay 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA BASE CATHETER AND WIRE. DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE LANTERN OVER THE WIRE AND INTO THE BASE CATHETER. SUBSEQUENTLY, THE PHYSICIAN KINKED THE LANTERN AT THE MIDSHAFT OUTSIDE OF THE PATIENT BODY. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME BASE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787808 ↗