Lantern Delivery Catheter PXSLIMLAN115T45Recalls & reported problems

Summary

The FDA's MAUDE database contains 121 adverse event reports that list this exact device (DI 00814548016627), received between Feb 27, 2016 and Sep 21, 2026 — classified as 2 injuries, 119 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (44 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 121 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848844 ↗
• MalfunctionAug 26, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50454053 ↗
• MalfunctionOct 23, 2024Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED THROUGH THE DIAGNOSTIC CATHETER AND INTO THE TARGET VESSEL. NEXT, THE PHYSICIAN WAS ADVANCING A GUIDEWIRE THROUGH THE LANTERN WHEN THE LANTERN WAS NOTICED TO BE KINKED. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN; HOWEVER, WHILE PULLING THE LANTERN OUT FROM THE DIAGNOSTIC CATHETER, THE PHYSICIAN FRACTURED LANTERN AT THE MIDSHAFT. IT WAS REPORTED THE PHYSICIAN WAS ABLE TO REMOVE THE PROXIMAL PORTION OF THE LANTERN, BUT THE DISTAL END OF THE LANTERN REMAINED IN THE DIAGNOSTIC CATHETER. THEREFORE, THE DIAGNOSTIC CATHETER CONTAINING THE FRACTURED DISTAL END OF THE LANTERN WAS REMOVED AND THE LANTERN WAS FLUSHED OUT. THE PROCEDURE COMPLETED USING A NEW LANTERN, A NEW DIAGNOSTIC CATHETER, AND RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517922 ↗
• MalfunctionFeb 7, 2022Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD COIL IN THE TARGET LOCATION. WHILE ADVANCING THE NEXT POD COIL, IT BECAME STUCK IN THE MIDDLE OF THE LANTERN. UPON REMOVAL FROM THE MICROCATHETER, THE PHYSICIAN INADVERTENTLY KINKED THE POD COIL PUSHER WIRE. IT WAS ALSO REPORTED THAT THE PHYSICIAN INADVERTENTLY BROKE THE LANTERN AT APPROXIMATELY THIRTY-NINE CENTIMETERS FROM THE DISTAL END AND KINKED IT AT APPROXIMATELY FIFTY-THREE CENTIMETERS FROM THE DISTAL END. IT IS UNKNOWN WHEN THE DAMAGE OCCURRED; HOWEVER, THE LANTERN REMAINED IN ONE PIECE AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, EIGHT POD PACKING COILS (POD PCS), A NON-PENUMBRA MICROCATHETER, 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 13476810 ↗
• MalfunctionNov 2, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, WHILE TRYING TO ADVANCE THE LANTERN THROUGH THE GUIDE SHEATH WITHOUT USING A GUIDEWIRE, THE LANTERN BROKE APPROXIMATELY 12CM FROM THE PROXIMAL END. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN BY PULLING IT OUT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME GUIDE SHEATH AND A GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740984 ↗
• MalfunctionNov 1, 2021Fracture; Material Deformation; Physical Resistance/Sticking; Fracture; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK VIA TRANSCAVAL APPROACH USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, UPON THE INITIAL ADVANCEMENT OF THE LANTERN THROUGH THE GUIDE SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE LANTERN KINKED AT THE MID-SHAFT AND BROKE. THE SAME ISSUE OCCURRED WITH TWO OTHER LANTERNS. THEREFORE, THE LANTERNS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH THROMBIN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12733874 ↗
• MalfunctionOct 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, RUBY COILS, POD PACKING COILS (POD PCS), A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE POD COILS AND TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A POD PC MID-SHAFT THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE POD PC WAS REMOVED. AFTERWARDS, WHILE ADVANCING ANOTHER POD PC MID-SHAFT THROUGH THE LANTERN, THE SAME ISSUE OCCURRED. THE PHYSICIAN EXPERIENCED RESISTANCE, THEREFORE, THE POD PC AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING THE TWO POD PCS THAT WERE PREVIOUSLY REMOVED 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 12601834 ↗
• MalfunctionSep 30, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE FIRST POD COIL THROUGH THE MIDDLE OF THE LANTERN. THEREFORE, THE POD WAS REMOVED AND FLUSHED ON THE BACK TABLE. WHILE RE-ADVANCING THE SAME POD COIL THROUGH THE MIDDLE OF THE LANTERN, RESISTANCE WAS AGAIN ENCOUNTERED. THEREFORE, THE POD COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME POD COIL, TWO ADDITIONAL POD COILS, SIX POD PACKING COILS (POD PCS), 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 12558247 ↗
• MalfunctionSep 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE LANTERN THROUGH THE MIDDLE OF THE CATHETER AND, SUBSEQUENTLY, THE LANTERN BECAME STUCK. THEREFORE, THE CATHETER WAS REMOVED FROM THE PROCEDURE AND EXCHANGED FOR A NEW ONE. NEXT, WHILE ADVANCING THE SAME LANTERN THROUGH THE MIDDLE OF A NEW CATHETER, RESISTANCE WAS ENCOUNTERED AND THE LANTERN BECAME STUCK. THEREFORE, THE LANTERN WAS REMOVED FROM 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 12497902 ↗
• 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 12436623 ↗
• MalfunctionAug 23, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTOPULMONARY COLLATERALS USING POD PACKING COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE OBTAINING ACCESS THROUGH A CATHETER, THE PHYSICIAN ATTEMPTED TO ADVANCE THE LANTERN THROUGH A PREVIOUSLY PLACED COIL MASS. WITH FORWARD TENSION ON THE LANTERN, THE TIP PROLAPSED INTO THE PARENT VESSEL. THE PHYSICIAN WAS THEN ABLE TO SUCCESSFULLY ADVANCE THE LANTERN THROUGH THE COIL MASS. THE PHYSICIAN ATTEMPTED TO DELIVER A POD PC INTO THE VESSEL, BUT IT WOULD NOT ADVANCE THROUGH THE TIP OF THE LANTERN. THEREFORE, THE POD PC AND THE LANTERN WERE REMOVED. IT WAS NOTED THAT THE TIP OF THE LANTERN HAD BECOME KINKED. THE PROCEDURE WAS COMPLETED USING NEW POD PCS 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 12354132 ↗
• MalfunctionAug 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHEN ADVANCING THE LANTERN THROUGH THE CATHETER AND INTO A SECOND VESSEL, THE LANTERN BROKE AT THE MIDSHAFT. IT WAS REPORTED THAT THE PATIENT ANATOMY WAS NOT VERY TORTUOUS, BUT THE CATHETER SEEMED LIKE IT TOOK A HARD TURN INTO THE VESSEL, AND THE LANTERN BROKE HIGHER, NEAR THE HUB OF THE CATHETER. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL OUT THE BROKEN LANTERN. 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 12291888 ↗
• MalfunctionAug 6, 2021Break; Break

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE VARICES USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE LOADING THE LANTERN INTO THE CATHETER, THE PHYSICIAN BROKE THE LANTERN INTO TWO PIECES AT THE DISTAL END. THEREFORE, THE PHYSICIAN REMOVED THE PROXIMAL SEGMENT OF THE LANTERN. IT WAS REPORTED THAT THE BROKEN PIECE OF THE LANTERN WAS STILL OUTSIDE OF THE CATHETER; THEREFORE, THE PHYSICIAN WAS ABLE TO REMOVE IT BY GRABBING THE BROKEN PIECE OF THE LANTERN AND PULLING IT OUT. 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 12291259 ↗
• MalfunctionJul 19, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA STENT, A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A STENT IN THE TARGET VESSEL. THE PHYSICIAN THEN PLACED THE MICROCATHETER THROUGH THE STENT AND WHEN ADVANCING A RUBY COIL AS THE FIRST COIL, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE DISTAL END OF THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL AND LANTERN. HOWEVER, WHILE RETRACTING, IT WAS NOTICED THAT THE RUBY COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. SUBSEQUENTLY, UPON REMOVAL, IT WAS NOTED THAT THE LANTERN WAS OVALIZED APPROXIMATELY TWO CENTIMETERS FROM THE DISTAL TIP. THE PROCEDURE WAS COMPLETED USING SIX NEW RUBY 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 12188766 ↗
• MalfunctionJul 15, 2021Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN RETRACTED THE LANTERN TO REPOSITION IT. WHILE RE-ADVANCING THE LANTERN THROUGH THE ROTATING HEMOSTASIS VALVE (RHV), THE PHYSICIAN BROKE THE LANTERN AT THE PROXIMAL END NEAR THE HUB. 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 12178492 ↗
• MalfunctionJul 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING RUBY COILS, LANTERN DELIVERY MICROCATHETERS (LANTERN), A NON-PENUMBRA SHEATH, AND A 4F GLIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN; HOWEVER, BOTH COILS WERE DETERMINED TO BE OVERSIZED. THEREFORE, BOTH RUBY COILS WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW RUBY COIL THROUGH THE LANTERN; HOWEVER, THE RUBY COIL WOULD NOT ADVANCE. UPON FURTHER INSPECTION, THE PHYSICIAN NOTICED A KINK TOWARDS THE HUB OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND SAVED FOR LATER USE. THE PHYSICIAN THEN REMOVED THE DAMAGED LANTERN AND INSERTED A NEW LANTERN INTO THE PATIENT. AFTERWARDS, THE PHYSICIAN IMPLANTED THE PREVIOUSLY REMOVED RUBY COIL IN THE TARGET VESSEL. WHILE ADVANCING A NEW RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE BUT WAS ABLE TO IMPLANT THE RUBY COIL IN THE TARGET VESSEL. SUBSEQUENTLY, WHEN THE SCRUB TECHNOLOGIST WAS RETRACTING THE LANTERN WITHOUT A GUIDEWIRE, BOTH RUBY COILS WERE PULLED BACK INTO THE BRACHIAL ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE BOTH RUBY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097702 ↗
• InjuryJun 25, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A LEFT LEG ARTERIOVENOUS MALFORMATION (AVM) OFF THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND AN EMBOLIC AGENT. DURING THE PROCEDURE, THE PHYSICIAN INJECTED AN EMBOLIC AGENT THROUGH THE LANTERN FOR SEVERAL MINUTES. THEN, THE PHYSICIAN ATTEMPTED TO REMOVE THE LANTERN; HOWEVER, THE LANTERN WAS STUCK DUE TO THE EMBOLIC AGENT THAT WAS USED. THEREFORE, THE PHYSICIAN PULLED THE LANTERN BACK WITH FORCE. UPON REMOVAL OF THE LANTERN FROM THE PATIENT, THE PHYSICIAN NOTICED IT WAS BROKEN. THE PHYSICIAN THEN NOTICED UNDER FLUOROSCOPY THAT THE LANTERN BROKE NEAR THE DISTAL END IN THE SFA. THE PHYSICIAN ATTEMPTED TO USE A SNARE DEVICE TO RETRIEVE THE BROKEN END OF THE LANTERN; HOWEVER, IT WAS UNSUCCESSFUL. SUBSEQUENTLY, THE PHYSICIAN PUSHED THE BROKEN END OF THE LANTERN DEEP INTO THE AVM USING THE SNARE DEVICE. IT WAS REPORTED THAT THE BROKEN END OF THE LANTERN WAS LEFT IN THE AVM AND THAT THE PHYSICIAN WAS NOT WORRIED ABOUT IT REMAINING IN THE AVM BECAUSE IT DID NOT HAVE A CHANNEL TO TRAVEL ANYWHERE ELSE IN THE BODY. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND AN EMBOLIC AGENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12072200 ↗
• MalfunctionJun 22, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PANCREATICODUODENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (POD PC), A DIAGNOSTIC CATHETER, AND A SHEATH. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED SEVERAL COILS IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO PLACE THE NEXT POD PC IN THE TARGET VESSEL, THE POD PC KEPT PUSHING BACK ON THE LANTERN. IT WAS REPORTED THAT THE PLACEMENT OF THE POD PC WAS CLOSER TO THE END OF THE VESSEL THAN PREVIOUSLY VISUALIZED CAUSING IT TO PUSH THE LANTERN BACK INTO THE MAIN BRANCH. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE LANTERN AND INADVERTENTLY KINKED THE DISTAL TIP OF THE LANTERN. IT WAS ALSO REPORTED THAT THE PHYSICIAN COULD NOT SEE THE TIP OF LANTERN AS THE PACKING WAS DENSE. THEREFORE, THE POD PC AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A SMALLER RUBY COIL 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 12045844 ↗
• MalfunctionJun 16, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PCS) AND LANTERN DELIVERY MICROCATHETERS (LANTERNS). DURING THE PROCEDURE, A POD PC WAS DETERMINED TO BE TOO LONG FOR THE COIL PACK. WHEN RETRACTING THE POD PC, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD PC UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE DETACHED POD PC AND LANTERN WERE THEN REMOVED TOGETHER. SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO FLUSH THE POD PC OUT OF THE LANTERN AND DECIDED TO USE A NEW LANTERN AND NEW POD PC. THE POD PC WAS ALSO DETERMINED TO BE TOO LONG FOR THE COIL PACK. WHEN RETRACTING THE POD PC, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE POD PC UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE DETACHED POD PC AND LANTERN WERE THEN REMOVED TOGETHER. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014237 ↗
• InjuryJun 2, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK LOCATED ON A BRANCH OF THE ILIOLUMBAR ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A NON-PENUMBRA SUPPORT CATHETER. DURING THE PROCEDURE, IT WAS NOTED THAT MANY SMALL BRANCHES WERE COMING OFF THE ILIOLUMBAR ARTERY AND THE PHYSICIAN SPENT APPROXIMATELY THIRTY TO FORTY-FIVE MINUTES SEARCHING FOR THE TARGET BRANCH. AFTER LOCATING THE TARGET BRANCH, THE PHYSICIAN BEGAN NAVIGATING THROUGH THE VASCULATURE AND INADVERTENTLY ADVANCED THE LANTERN UP THE WRONG BRANCH. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE LANTERN AND IT WAS NOTED THAT THE BRANCH WAS SMALL. THE LANTERN WAS UNABLE TO CONTINUE TRACKING AND SUBSEQUENT IMAGING REVEALED THAT A VESSEL PERFORATION HAD OCCURRED. WHILE ADVANCING A RUBY COIL THROUGH THE VESSEL TO EMBOLIZE THE PERFORATION, RESISTANCE WAS ENCOUNTERED, AND THE LANTERN WAS PUSHED OUT OF POSITION. IT WAS REPORTED THAT THE RUBY COIL WAS TOO LARGE, AND THE VESSEL WAS TOO SMALL; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED FROM THE PATIENT. WHILE WIPING DOWN THE LANTERN WITH WET GAUZE ON THE BACK TABLE, THE TECHNICIAN INADVERTENTLY BROKE IT. THEREFORE,

  Patient problems: Perforation of Vessels

  MAUDE report 11925498 ↗
• MalfunctionMay 18, 2021Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK OF AN AORTIC GRAFT USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA ANGIOGRAPHIC CATHETER. DURING THE PROCEDURE, A LANTERN WAS ADVANCED THROUGH THE ANGIOGRAPHIC CATHETER AND INTO THE TARGET LOCATION; HOWEVER, THE PHYSICIAN DECIDED TO REPOSITION THE LANTERN PRIOR TO DELIVERING THE FIRST COIL. SUBSEQUENTLY, WHILE REMOVING THE LANTERN OUT FROM THE ANGIOGRAPHIC CATHETER, THE PHYSICIAN NOTICED THE LANTERN TO BE KINKED AND BROKEN. 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 11841707 ↗
• MalfunctionApr 20, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AZYGOS OFF THE INFERIOR VENA CAVA (IVC) USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE INSERTING A POD PC INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE LANTERN. IT WAS REPORTED THAT BOTH THE POD PC AND LANTERN WERE BENT. THEREFORE, THE POD PC AND THE LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW COIL 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 11694563 ↗
• MalfunctionMar 8, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A PARENT CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PARENT CATHETER AND LANTERN IN THE TARGET LOCATION AND THEN FLUSHED THE LANTERN. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN AND DECIDED TO RETRACT THE RUBY COIL. HOWEVER, UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE MID-SHAFT OF THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW 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 11435892 ↗
• MalfunctionFeb 26, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A RUBY COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A NON-PENUMBRA SUPPORT CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL INTO THE TARGET VESSEL USING THE LANTERN AND SUPPORT CATHETER. THEN, WHILE THE RUBY COIL STARTED TO FORM IN THE TARGET VESSEL, THE LANTERN KICKED BACK INTO THE SUPPORT CATHETER AND SUBSEQUENTLY, THE RUBY COIL, COILED OFF IN THE SUPPORT CATHETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE RUBY COIL. UPON RETRACTION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED. AFTER REMOVING THE LANTERN, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE LANTERN WAS KINKED. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. AFTERWARDS, WHILE ATTEMPTING TO INSERT A POD COIL INTO A NEW LANTERN, THE HOSPITAL TECHNOLOGIST BENT THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, THE SAME SECOND LANTERN, AND A NEW SUPPORT CATHETER. TH

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11387858 ↗
• MalfunctionFeb 24, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A SHEATH. DURING THE PROCEDURE, THE FIRST RUBY COIL WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. SUBSEQUENTLY, TWO RUBY COILS WERE SUCCESSFULLY IMPLANTED INTO THE TARGET LOCATION. NEXT, TWO RUBY COILS WOULD NOT ADVANCE PAST THE MIDDLE OF THE LANTERN. THEREFORE, THESE RUBY COILS WERE REMOVED. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND, UPON REMOVAL, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED PROXIMAL TO THE HUB. THEREFORE, THE LANTERN WAS NO LONGER USED IN THE PROCEDURE. THE PHYSICIAN USED A NEW LANTERN TO SUCCESSFULLY IMPLANT ONE RUBY COIL. HOWEVER, THE NEXT RUBY COIL WOULD NOT ADVANCE PAST THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, ANOTHER RUBY COIL, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11376177 ↗