Lantern Delivery Catheter PXSLIMLAN150STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00814548016672), received between Jul 12, 2016 and Mar 31, 2026 — classified as 4 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (25 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), COILS, AND A NON-PENUMBRA SHEATH. A LANTERN WAS ADVANCED, AND TWO COILS WERE DELIVERED. HOWEVER, WHILE ADVANCING THE THIRD COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN HAD FRACTURED AT BOTH THE PROXIMAL AND DISTAL ENDS. ALTHOUGH DAMAGED, THE LANTERN WAS ABLE TO BE PULLED BACK THROUGH THE SHEATH. 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 24747571 ↗
• MalfunctionMar 24, 2026Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL ILIAC ARTERY TO TREAT A TYPE II ENDOLEAK USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WOULD NOT ADVANCE. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN. THE LANTERN WAS REMOVED. AFTER REMOVAL OF THE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS FRACTURED AT THE MIDSHAFT. 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 24676672 ↗
• MalfunctionMar 16, 2026Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A BASE CATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE BASE CATHETER OVER A GUIDEWIRE AND INTO THE TARGET LOCATION, THE LANTERN FRACTURED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO PULL OUT THE ENTIRE FRACTURED LANTERN BY HAND AND SUCCESSFULLY REMOVE IT. 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 24602415 ↗
• InjuryJun 23, 2025Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED OVER A GUIDEWIRE TO THE TARGET LOCATION. WHEN THE LANTERN WAS BEING WITHDRAWN FROM THE IMA, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE DISTAL LENGTH OF THE LANTERN FRACTURED. A SNARE DEVICE WAS USED TO RETRIEVE THE FRACTURED LANTERN LENGTH. THE ATTEMPT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED LANTERN LENGTH IN THE IMA. THE PROCEDURE ENDED AT THIS POINT. THE PATIENT WAS ADMITTED INTO THE HOSPITAL AND WAS RECEIVING FREQUENT ABDOMINAL CHECKS. IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 22311964 ↗
• MalfunctionApr 28, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED USING A LANTERN DELIVERY MICROCATHETER AND COILS. DURING THE PROCEDURE, THE LANTERN FRACTURED. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921535 ↗
• MalfunctionMar 14, 2025Fracture; Leak/Splash; Fracture; Leak/Splash

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA SHEATH AND A NON-PENUMBRA CATHETER (0.035). IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED TO THE TARGET LOCATION. NEXT, CONTRAST WAS INJECTED AND IT WAS NOTICED THAT THE CONTRAST WAS LEAKING FROM THE LANTERN AND THE LANTERN WAS FRACTURED. THEREFORE, THE LANTERN WAS PULLED OUT OF THE CATHETER AND WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME SHEATH 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 21612777 ↗
• InjuryAug 21, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE IN THE MARGINAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH (5FR X 10CM), AND A GUIDEWIRE (.014, 300CM). IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN STARTED WITH THE NON-PENUMBRA MICROCATHETER, BUT IT DID NOT HAVE ENOUGH LENGTH, SO HE EXCHANGED TO THE LANTERN OVER THE GUIDEWIRE. THE PHYSICIAN WAS SEARCHING FOR A BLEED IN THE MARGINAL ARTERY; HOWEVER, NOTICED UNDER FLUOROSCOPY THAT HE WAS IN A SMALL COLLATERAL VESSEL, SO THE GUIDEWIRE WAS REINSERTED INTO THE LANTERN AND THE LANTERN WAS RETRACTED. THE GUIDEWIRE WAS THEN REMOVED AND ANOTHER IMAGE WAS TAKEN; HOWEVER, AT THIS TIME, THE PHYSICIAN NOTICED THAT THE TIP OF THE LANTERN WAS DISTAL TO WHERE THE CONTRAST WAS COMING OUT. THE PHYSICIAN COULD VISUALIZE UNDER FLUOROSCOPY THAT THE LANTERN¿S DISTAL 3CM TIP (RADIOPAQUE MARKER TO RADIOPAQUE MARKER) HAD BROKEN OFF INTO THE MARGINAL ARTERY. THE PHYSICIAN DECIDED TO LEAVE THE FRACTURED LANTERN TIP IN THE PATIENT''S VESSEL TO NOT CAUSE ANY ADDITIONAL HARM. THE PROCEDURE ENDED AT THIS POINT. IT IS REPORTED THAT THE PATIENT IS STA

  Patient problems: Foreign Body In Patient

  MAUDE report 20014935 ↗
• MalfunctionJul 12, 2024Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A POD COIL, POD PACKING COIL (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA SHEATHS, AND A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL AND PACKING COIL IN THE FIRST PAVM USING THE LANTERN. NEXT, WHILE ADVANCING THE LANTERN INTO THE SECOND PAVM, THE PHYSICIAN NOTICED THE MIDSHAFT OF THE LANTERN HAD FRACTURED INSIDE THE DIAGNOSTIC CATHETER. THE PHYSICIAN WAS ABLE TO REMOVE APPROXIMATELY 40 CENTIMETERS OF THE FRACTURED LANTERN OUT FROM THE DIAGNOSTIC CATHETER. THE DIAGNOSTIC CATHETER WAS THEN REMOVED, AND A GOOSENECK SNARE DEVICE WAS USED TO REMOVE THE REST OF THE FRACTURED LANTERN OUT FROM THE SHEATH. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO OBTAIN ACCESS BACK INTO THE VESSEL. THE PHYSICIAN ENDED THE PROCEDURE AT THIS POINT AND THE PATIENT WILL BE BROUGHT BACK ON A DIFFERENT DAY TO COMPLETE THE EMBOLIZATION PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735771 ↗
• MalfunctionMay 6, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COMMON ILIAC ARTERY (CIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, POD PACKING COILS (PACKING COILS), A NON-PENUMBRA CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND FRACTURED THE MIDSHAFT OF THE LANTERN IN MULTIPLE PLACES. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER CONTAINING THE FRACTURED LANTERN. THE PHYSICIAN THEN IMPLANTED THREE RUBY COILS IN THE TARGET LOCATION USING A NEW LANTERN. THE PHYSICIAN THEN FLUSHED THE LANTERN. WHILE ADVANCING A PACKING COIL THROUGH THE LANTERN AND INTO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN THEN USED ANOTHER PACKING COIL TO PUSH THE DETACHED PACKING COIL INTO THE TARGET LOCATION. THE PROCEDURE WAS COMPLETED AFTER PLACING THE PACKING COIL USING THE SECOND 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 19250345 ↗
• MalfunctionApr 12, 2024Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE PORTAL VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO RETRACT THE LANTERN TO REPOSITION THE DIAGNOSTIC CATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND FELT A SNAP. THEREFORE, THE PHYSICIAN PULLED THE DIAGNOSTIC CATHETER OUT WITH THE LANTERN AND NOTICED THAT THE LANTERN WAS FRACTURED AT THE MID-SHAFT. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER, THE SAME DIAGNOSTIC 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 19097120 ↗
• 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 18673483 ↗
• MalfunctionNov 28, 2023Fracture; Fracture

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA DIAGNOSTIC CATHETER. IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS VERY TORTUOUS. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED THROUGH THE DIAGNOSTIC CATHETER. WHILE ATTEMPTING TO REMOVE THE LANTERN, THE PHYSICIAN PULLED THE LANTERN INTO THE DIAGNOSTIC CATHETER AND FELT THAT THE LANTERN FRACTURED AT THE MID-SHAFT INSIDE THE DIAGNOSTIC CATHETER. THE PHYSICIAN REMOVED THE DIAGNOSTIC CATHETER AND LANTERN TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220619 ↗
• InjuryMay 30, 2023Unraveled Material

  DURING DEPLOYMENT OF A COIL TO EMBOLIZE BLEEDING, A COIL WAS NOT FULLY DEPLOYED AND WAS STUCK IN THE MICRO CATHETER. BOTH UNRAVELING COIL AND MICRO CATHETER WERE REMOVED FROM PATIENT VIA SHEATH BUT A COMPONENT OF THE COIL REMAINED IN THE PATIENT. VASCULAR SURGEON HAD TO GO BACK IN 3 TIMES TO REMOVE FRAGMENTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17019079 ↗
• MalfunctionMar 16, 2023Fracture; 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), NEURON SELECT CATHETER 5F (5F SELECT), POD PACKING COIL (POD PC), AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING A GUIDEWIRE THROUGH THE LANTERN AND INTO THE TARGET VESSEL. IT WAS REPORTED THE PHYSICIAN MAY HAVE PUNCTURED THE LANTERN WITH THE GUIDEWIRE. NEXT, THE PHYSICIAN REMOVED THE GUIDEWIRE AND ATTEMPTED TO ADVANCE A POD PC AND OTHER COILS THROUGH THE LANTERN, BUT THE COILS WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN HAD DIFFICULTY REMOVING THE LANTERN AND UPON REMOVAL, THE PHYSICIAN BENT AND BROKE THE DISTAL END OF THE LANTERN. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16559043 ↗
• MalfunctionDec 31, 2022Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. SUBSEQUENTLY, WHILE REMOVING THE LANTERN, THE PHYSICIAN NOTICED THE DISTAL END OF THE LANTERN TO BE CRACKED. IT WAS REPORTED THAT THE LANTERN WAS REMOVED WITHOUT ANY ISSUE. 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 16081060 ↗
• MalfunctionOct 31, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COIL LPS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AN LP SYSTEM DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA 5F CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS EXPERIENCING RESISTANCE ADVANCING THE LANTERN THROUGH THE NON-PENUMBRA CATHETER. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A FLUOROSCOPY AND NOTICED THE LANTERN WAS BROKEN IN HALF INTO TWO PIECES BUT WAS CONNECTED BY A TINY THREAD. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE THROUGH THE BROKEN LANTERN AND REMOVED THE LANTERN. A NEW LANTERN WAS THEN INSERTED INTO THE TARGET LOCATION. NEXT, THE PHYSICIAN ADVANCED A RUBY COIL LP INTO 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 BREAK THE DISTAL END OF THE PUSHER ASSEMBLY TO MANUALLY DETACH THE RUBY COIL LP, BUT THE COIL STILL WOULD NOT DETACH. THEREFORE, THE RUBY COIL LP WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FIVE NEW RUBY COIL LPS, THE SAME HANDLE, LANTERN, AND CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15700908 ↗
• MalfunctionOct 20, 2022Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE UTERINE ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NEURON SELECT CATHETER 5F (5F SELECT). DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH 5F SELECT, THE PHYSICIAN BROKE THE HUB OFF THE PROXIMAL END OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA MICROCATHETER AND THE SAME 5F SELECT. THERE WAS NO REPORT OF AN EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15641279 ↗
• MalfunctionNov 29, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, POD COILS, AND POD PACKING COILS (POD PC). DURING THE PROCEDURE, THE PHYSICIAN PLACED SEVERAL RUBY COILS, POD COILS, AND POD PCS IN THE TARGET VESSEL USING THE LANTERN. NEXT, WHILE ATTEMPTING TO PLACE ANOTHER POD COIL IN THE TARGET LOCATION, THE PHYSICIAN WAS ONLY ABLE TO ADVANCE APPROXIMATELY FORTY PERCENT OF A POD COIL INTO THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN TO BE FLUSHED. SUBSEQUENTLY, AFTER FLUSHING, THE LANTERN WAS REINSERTED BACK INTO THE TARGET LOCATION. HOWEVER, WHEN THE PHYSICIAN WAS UNABLE TO ADVANCE THE SAME POD COIL THROUGH THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND THE SAME POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888885 ↗
• MalfunctionSep 3, 2021Break; Unraveled Material; Break; Unraveled Material

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBSEGMENTAL PULMONARY ARTERY USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GUIDE CATHETER AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. NEXT, WHILE ATTEMPTING TO ADJUST THE POSITION OF THE LANTERN, THE PHYSICIAN FELT SOMETHING WAS NOT RIGHT. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN. UPON REMOVAL, IT WAS NOTICED THAT THE LANTERN WAS BROKEN AND UNRAVELED FROM MID TO DISTAL SHAFT. IT WAS REPORTED THAT THE LANTERN BROKE BUT REMAINED CONNECTED BY A THREAD. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME GUIDE 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 12421594 ↗
• MalfunctionJul 6, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND DIAGNOSTIC CATHETER. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS INSERTING THE LANTERN THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) AND INTO THE DIAGNOSTIC CATHETER, THE HOSPITAL TECHNOLOGIST NOTICED THE DISTAL END OF THE LANTERN TO BE KINKED. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN WITH A POD COIL, POD PACKING COIL (POD PC), 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 12124220 ↗
• MalfunctionMay 19, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK SAC IN THE INFERIOR MESENTERIC ARTERY (IMA) USING RUBY COIL LPS, PACKING COIL LPS, LP SYSTEM DETACHMENT HANDLE (HANDLE), LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A LANTERN THROUGH THE DIAGNOSTIC CATHETER AND THE LANTERN BECAME STUCK. THE LANTERN WAS REMOVED AND A NEW MICROCATHETER WAS USED. THE PHYSICIAN THEN ATTEMPTED TO DETACH A FIRST PACKING COIL LP USING A HANDLE; HOWEVER, THE PACKING COIL LP FAILED TO DETACH. THE PHYSICIAN USED A NEW HANDLE; HOWEVER, THE PACKING COIL LP STILL FAILED TO DETACH. A HEMOSTAT WAS USED TO MANUALLY DETACH THE COIL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A SECOND PACKING COIL LP; HOWEVER, THE PACKING COIL LP WOULD NOT ADVANCE PAST THE FRICTION LOCK WITHIN ITS INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO ADVANCE A THIRD PACKING COIL LP BUT, THE SAME ISSUE OCCURRED. A FOURTH PACKING COIL LP WAS ADVANCED TO THE TARGET LOCATION BUT HAD DIFFICULTY DETACHING. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO MANUALLY DETACH THE COIL. A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848351 ↗
• MalfunctionMay 18, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A MEDICAL PROCEDURE IN THE INTERNAL ILIAC/HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A BASE CATHETER, A 6F SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN OVER THE GUIDEWIRE INTO THE TARGET VESSEL. THE PHYSICIAN THEN PERFORMED A FEW POWER INJECTIONS THROUGH THE LANTERN TO VISUALIZE THE VESSEL. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE LANTERN FURTHER. WHILE RE-INSERTING THE GUIDEWIRE INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE LANTERN WOULD NOT ADVANCE FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND THE GUIDEWIRE. HOWEVER, WHILE REMOVING THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND PULLED THE LANTERN WITH FORCE. UPON REMOVAL OF THE ENTIRE LANTERN, THE PHYSICIAN NOTICED THAT THE LANTERN WAS BROKEN AT THE DISTAL END. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842395 ↗
• MalfunctionMay 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE THE BRACHIAL BRANCH USING A POD COIL, RUBY COILS, AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. NEXT, THE POD COIL BECAME STUCK WHILE ADVANCING THROUGH THE LANTERN; THEREFORE, THE POD COIL AND LANTERN WERE REMOVED. THE PHYSICIAN INSERTED A NEW LANTERN INTO THE TARGET LOCATION, AND ATTEMPTED TO ADVANCE A RUBY COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE AND THE RUBY COIL BECAME STUCK. THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE PROCEDURE WAS COMPLETED USING 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 11821843 ↗
• MalfunctionApr 15, 2021Failure to Advance; Material Deformation; Physical Resistance/Sticking; Failure to Advance; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) TO THE INFERIOR MESENTERIC ARTERY (IMA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (POD PCS), A NON-PENUMBRA CATHETER. DURING THE PROCEDURE, WHILE INSERTING THE LANTERN INTO THE CATHETER THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE LANTERN BECAME KINKED. THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PC THROUGH THE LANTERN AND WAS UNABLE TO; THEREFORE, THE POD PC WAS RE-SHEATHED AND THE LANTERN WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME POD PC, ADDITIONAL 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 11671366 ↗
• MalfunctionMar 4, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN USED A LANTERN TO NAVIGATE THE VESSEL AND PERFORMED AN ANGIOGRAM. LATER, WHILE REPOSITIONING THE LANTERN FOR A THIRD TIME, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN KINKED THE PROXIMAL END OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING 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; No Consequences Or Impact To Patient

  MAUDE report 11413288 ↗