Lantern Delivery Catheter PXSLIMLAN135STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 00814548016641), received between Mar 23, 2016 and Sep 29, 2026 — classified as 2 injuries, 181 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (74 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 183 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935809 ↗
• MalfunctionMar 20, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. AFTER PLACING THE EMBOLIZATION COILS, THE LANTERN HAD FRACTURED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE FRACTURED LANTERN. IT WAS ALSO REPORTED THAT A SECOND LANTERN FRACTURED DURING THE PROCEDURE AND THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650810 ↗
• MalfunctionMar 20, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. AFTER PLACING THE EMBOLIZATION COILS, THE LANTERN HAD FRACTURED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE FRACTURED LANTERN. IT WAS ALSO REPORTED THAT A SECOND LANTERN FRACTURED DURING THE PROCEDURE AND THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650799 ↗
• MalfunctionMar 13, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A PARENT CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ACCESS THE VESSEL USING THE LANTERN AND PARENT CATHETER FOR APPROXIMATELY AN HOUR, THE PHYSICIAN NOTICED THE DISTAL END OF THE LANTERN WAS FRACTURED. THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE FRACTURED LANTERN OUT FROM THE PARENT CATHETER. 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 24597898 ↗
• MalfunctionDec 6, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE UTERINE ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA BASE CATHETER, AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE BASE CATHETER. THE LANTERN WAS THEN REMOVED TO REPOSITION AFTER LOSING ACCESS TO THE TARGET VESSEL. WHILE READVANCING THE LANTERN BACK INTO THE BASE CATHETER TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE REMOVING THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS FRACTURED AT THE DISTAL END. THE PROXIMAL FRACTURED PORTION OF THE LANTERN WAS REMOVED. THE BASE CATHETER CONTAINING THE REMAINING FRACTURED PORTION OF THE LANTERN WAS REMOVED AND THE FRACTURED PORTION OF THE LANTERN WAS FLUSHED OUT OF THE BASE CATHETER. NO FRAGMENTS OF THE LANTERN WERE LEFT IN THE PATIENT¿S BODY. THE PROCEDURE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866321 ↗
• MalfunctionAug 9, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) AND INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (PACKING COIL), AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS HIGHLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS AND ONE PACKING COIL INTO THE IIA USING THE LANTERN. WHILE ATTEMPTING TO CANNULATE THE IMA WITH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. AFTER REPEATED ATTEMPTS, THE IMA WAS CANNULATED WITH THE LANTERN. WHILE ADVANCING A NON-PENUMBRA COIL (IDC) THROUGH THE LANTERN, RESISTANCE WAS ENCOUNTERED, AND THE COIL BECAME STUCK AND WOULD NOT ADVANCE OUT OF THE DISTAL END OF THE LANTERN. THEREFORE, THE LANTERN WAS CONTAINING THE COIL WAS REMOVED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE DISTAL END OF THE LANTERN WAS FRACTURED. IT WAS REPORTED THAT THE COIL WAS FLUSHED OUT OF THE LANTERN. 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 19956075 ↗
• MalfunctionMay 24, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A RUBY COIL. DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN, THE PHYSICIAN NOTICED THE LANTERN FRACTURED AT THE PROXIMAL END. THEREFORE, THE LANTERN WAS DISCONNECTED FROM THE ROTATING HEMOSTASIS VALVE (RHV) AND THEN REMOVED. THE PROCEDURE 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 19392232 ↗
• 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 18984246 ↗
• MalfunctionMar 25, 2024Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS ATTEMPTING TO POSITION THE LANTERN IN THE TARGET LOCATION FOR APPROXIMATELY THREE TO FOUR MINUTES. AFTERWARDS, THE PHYSICIAN ATTEMPTED TO FLUSH THE LANTERN, BUT IT WOULD NO LONGER FLUSH. THEN UPON INSPECTING THE LANTERN UNDER X-RAY, THE PHYSICIAN NOTICED THAT THE MIDSHAFT OF THE LANTERN WAS KINKED AND FRACTURED. THEREFORE, THE LANTERN WAS REMOVED OVER A GUIDEWIRE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NON-PENUMBRA SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970424 ↗
• MalfunctionMar 23, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT ATRIAL APPENDAGE USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A RUBY COIL, A PACKING COIL (PC), AND A NON-PENUMBRA SHEATH. IT WAS REPORTED THAT THE PATIENT HAD A NON-PENUMBRA LEFT ATRIAL APPENDAGE CLOSURE PLACED IN THE HEART AND THERE WAS A SMALL AREA WHERE BLOOD FLOW WAS NOTICED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE SHEATH AND DECIDED TO REMOVE THE LANTERN TO EXCHANGE THE SHEATH FOR BETTER SUPPORT. WHILE REMOVING THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS FRACTURED AT THE PROXIMAL END. THE LANTERN WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN, A RUBY COIL, A PACKING COIL (PC), 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 18965924 ↗
• MalfunctionMar 22, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND PACKING COIL (PC). DURING THE PROCEDURE, THE PHYSICIAN DELIVERED SIX PODS COILS AND FOUR PCS TO THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN DECIDED TO DELIVER A SCLEROSING AGENT (SOTRODECOL) THROUGH THE LANTERN AND NOTICED THAT THE LANTERN WAS FRACTURED AT THE HUB. THEREFORE, THE LANTERN WAS REMOVED AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING 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 18964795 ↗
• MalfunctionNov 20, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE RUBY COIL AND ONE POD PACKING COIL (POD PC) INTO THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN RETRACTED THE LANTERN TO PLACE IT IN ANOTHER LUMBAR ARTERY AND UPON REMOVAL THE PHYSICIAN FRACTURED THE LANTERN NEAR THE MID-SHAFT. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED WAS 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 18174654 ↗
• MalfunctionOct 25, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN OVER A GUIDEWIRE AND THROUGH THE DIAGNOSTIC CATHETER. HOWEVER, WHILE REPOSITIONING THE LANTERN, THE PHYSICIAN FRACTURED THE MIDSHAFT OF THE LANTERN. IT WAS REPORTED THAT THE FRACTURED LOCATION ON THE LANTERN WAS OUTSIDE THE PATIENT. THEREFORE, THE PHYSICIAN WAS ABLE TO PULL AND REMOVE THE FRACTURED LANTERN OUT FROM THE DIAGNOSTIC CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER 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 18008302 ↗
• MalfunctionOct 13, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL OFF AXILLARY ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE LANTERN PROLAPSED DISTALLY AND WAS STUCK INSIDE THE DIAGNOSTIC CATHETER. THE PHYSICIAN THEN DECIDED TO REMOVE THE LANTERN; HOWEVER, UPON REMOVING THE LANTERN OUT FROM THE DIAGNOSTIC CATHETER, THE DISTAL END OF THE LANTERN FRACTURED INTO TWO PIECES. IT WAS REPORTED THAT THE FRACTURED LANTERN REMAINED INTACT BY A WIRE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE DIAGNOSTIC CATHETER AND THEN USED A FORCEPS TO REMOVE THE FRACTURED LANTERN FROM THE PATIENT. 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 17935928 ↗
• MalfunctionAug 14, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A GUIDEWIRE THROUGH THE LANTERN, THE PHYSICIAN NOTICED THE MIDSHAFT OF THE LANTERN WAS BROKEN AND THE GUIDEWIRE HAD COME OUT THROUGH THE BROKEN SECTION OF THE LANTERN. IT WAS REPORTED THAT THE BROKEN SECTION OF THE LANTERN WAS OUTSIDE OF THE PATIENT. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME RHV. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541733 ↗
• MalfunctionAug 2, 2023Fracture; Unraveled Material; Fracture; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, A NON-PENUMBRA GUIDE CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION USING THE LANTERN. WHILE ATTEMPTING TO REMOVE THE PUSHER ASSEMBLY OF THE LAST COIL FROM THE LANTERN, THE PHYSICIAN NOTICED THAT THE PROXIMAL END OF THE LANTERN WAS FRACTURED AND THE MID-SHAFT WAS UNRAVELED. IT WAS REPORTED THAT THE LANTERN WAS FRACTURED BUT REMAINED CONNECTED BY A THREAD. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN BY PULLING IT OUT. THE PROCEDURE ENDED AT THIS POINT AND THE VESSEL WAS COMPLETELY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446183 ↗
• MalfunctionJul 27, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN OVER THE GUIDEWIRE TO THE TARGET LOCATION, THE LANTERN FRACTURED AT THE PROXIMAL LOCATION. THEREFORE, THE LANTERN WAS REMOVED IN ITS ENTIRETY. 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 17406453 ↗
• MalfunctionJul 7, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE LUMBAR ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA IMAGING CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE IMAGING CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT WAS ABLE TO ADVANCE THE LANTERN TO THE TARGET VESSEL. NEXT, WHILE SELECTING ANOTHER BRANCH OF THE LUMBAR ARTERY, THE PHYSICIAN NOTICED UNDER CONTRAST IMAGING AND FELT THE LANTERN HAD FRACTURED FROM THE PROXIMAL END TO THE MIDSHAFT BUT REMAINED CONNECTED BY THE INNER WIRE. THEREFORE, THE LANTERN WAS REMOVED MANUALLY. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY MOVING THE LANTERN AND THAT THE LANTERN WAS TORQUED IN THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME IMAGING CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17280008 ↗
• MalfunctionJul 3, 2023Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE GUIDE CATHETER, THE PHYSICIAN KINKED THE PROXIMAL END OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE LANTERN WAS BROKEN BEFORE EXITING THE DISTAL END OF THE GUIDE CATHETER. IT WAS REPORTED THAT THE LANTERN BROKE BUT WAS STILL CONNECTED. THE PHYSICIAN THEN REMOVED THE LANTERN FROM THE SHEATH BY PULLING IT OUT AND ADVANCED A NEW LANTERN THROUGH THE GUIDE CATHETER. HOWEVER, THE SECOND LANTERN ALSO KINKED AND BROKE AT THE PROXIMAL END. THEREFORE, THE SECOND LANTERN WAS REMOVED FROM THE SHEATH BY PULLING IT OUT. IT WAS REPORTED THAT A GUIDEWIRE WAS NOT USED IN THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, THE SAME GUIDE CATHETER, 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 17248353 ↗
• MalfunctionJul 3, 2023Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE GUIDE CATHETER, THE PHYSICIAN KINKED THE PROXIMAL END OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE LANTERN WAS BROKEN BEFORE EXITING THE DISTAL END OF THE GUIDE CATHETER. IT WAS REPORTED THAT THE LANTERN BROKE BUT WAS STILL CONNECTED. THE PHYSICIAN THEN REMOVED THE LANTERN FROM THE SHEATH BY PULLING IT OUT AND ADVANCED A NEW LANTERN THROUGH THE GUIDE CATHETER. HOWEVER, THE SECOND LANTERN ALSO KINKED AND BROKE AT THE PROXIMAL END. THEREFORE, THE SECOND LANTERN WAS REMOVED FROM THE SHEATH BY PULLING IT OUT. IT WAS REPORTED THAT A GUIDEWIRE WAS NOT USED IN THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, THE SAME GUIDE CATHETER, 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 17248342 ↗
• MalfunctionMay 15, 2023Break; Material Deformation; Physical Resistance/Sticking; Break; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD PC INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A NEW POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE POD PC. HOWEVER, RESISTANCE WAS STILL ENCOUNTERED. THEREFORE, THE LANTERN CONTAINING THE POD PC WAS REMOVED. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE LANTERN WAS OVALIZED NEAR THE DISTAL END. IT WAS REPORTED THAT THE LANTERN WAS ALSO FRACTURED BETWEEN THE DISTAL END TO MID SHAFT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND FOUR ADDITIONAL POD PCS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935262 ↗
• MalfunctionApr 7, 2023Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS ADVANCING THE LANTERN WITHOUT A GUIDEWIRE THROUGH THE VESSEL WHILE INJECTING CONTRAST INTERMITTENTLY TO LOCATE THE TARGET VESSEL; HOWEVER, THE PHYSICIAN STARTED TO EXPERIENCE RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE LANTERN AND NOTICED IT HAD KINKED AND BROKEN AT MULTIPLE LOCATIONS. 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 16698337 ↗
• MalfunctionFeb 1, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY BRANCH USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COIL LP, A NON-PENUMBRA ANGIOGRAPHIC CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE ANGIOGRAPHIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE MIDSHAFT OF THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND NOTICED THE LANTERN HAD FRACTURED AT THE MIDSHAFT. THE PHYSICIAN THEN INSERTED A NEW MICROCATHETER INTO THE TARGET LOCATION AND THEN PLACED MULTIPLE RUBY COIL LPS IN THE VESSEL AND DETACHED THEM USING THE HANDLE. SUBSEQUENTLY, THE PHYSICIAN PLACED ANOTHER RUBY COIL LP IN THE VESSEL AND ATTEMPTED TO DETACH IT USING A HANDLE; HOWEVER, THE RUBY COIL LP FAILED TO DETACH. IT WAS ALSO REPORTED THAT THE PHYSICIAN ATTEMPTED TO MANUALLY DETACH THE RUBY COIL LP, BUT THE COIL WOULD NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COIL LPS, PACKING COIL LPS, NON-PENUMBRA COILS, AND THE SAME HANDLE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281594 ↗
• MalfunctionJan 6, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS STEEPLY ANGLED NEAR THE TARGET VESSEL. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR COILS AND TWO POD PACKING COILS (POD PCS) INTO THE TARGET LOCATION. IT WAS ALSO REPORTED THAT THE LANTERN WAS TORQUED MANY TIMES WITHIN THE STEEPLY ANGLED ANATOMY AND RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT. NEXT, WHILE VISUALIZING THE MOVEMENT OF THE LANTERN VIA ANGIOGRAM, THE PHYSICIAN NOTICED THAT THE LANTERN WAS NOT RESPONDING. SUBSEQUENTLY, THE LANTERN WAS REMOVED FROM THE PATIENT. ON THE BACK TABLE, THE PHYSICIAN FOUND THAT THE LANTERN WAS KINKED AND FRACTURED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, SIX COILS, THE SAME 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 16117673 ↗
• MalfunctionJan 6, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROFUNDA BRANCH USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, AFTER ADVANCING THE LANTERN THROUGH THE NON-PENUMBRA CATHETER, THE PHYSICIAN DECIDED TO REPOSITION THE LANTERN WITHIN THE VESSEL. SUBSEQUENTLY, WHILE RETRACTING THE LANTERN THROUGH THE CATHETER, THE PHYSICIAN BROKE THE LANTERN IN HALF. THE PHYSICIAN WAS ABLE TO PULL THE ENTIRE LANTERN AND REMOVE IT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME NON-PENUMBRA CATHETER, AND TWO RUBY COILS. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112273 ↗