Lantern Delivery Catheter PXSLIMLAN115STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00814548016610), received between May 4, 2016 and Jul 11, 2023 — classified as 39 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN MULTIPLE VESSELS IN THE LEFT HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA SELECT CATHETER AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY EMBOLIZED ONE OF THE VESSELS USING THE LANTERN. THE LANTERN WAS THEN REMOVED AND FLUSHED ON THE BACK TABLE. THE PHYSICIAN THEN ADVANCED THE LANTERN THROUGH THE SELECT CATHETER TO ANOTHER VESSEL. WHILE ADVANCING THE GUIDEWIRE THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE GUIDEWIRE WOULD NOT ADVANCE AND THE GUIDEWIRE WAS OUTSIDE OF THE LANTERN. THEREFORE, THE LANTERN WAS REMOVED. UPON REMOVAL, THE GUIDEWIRE WAS ADVANCED AGAIN THROUGH THE LANTERN ON THE BACK TABLE. SUBSEQUENTLY, A SEPARATION WAS NOTICED ON THE LANTERN WHERE THE GUIDEWIRE EXITED NEAR 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 LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302236 ↗
• MalfunctionMar 27, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LIVER VARICES USING RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE GUIDE CATHETER AND INTO THE TARGET LOCATION. SUBSEQUENTLY, THE PHYSICIAN PLACED AND DETACHED A RUBY COIL IN THE VESSEL; HOWEVER, WHILE REMOVING THE PUSHER ASSEMBLY OF THE COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND BROKE THE DISTAL END OF THE LANTERN. IT WAS REPORTED THAT THE LANTERN WAS BROKEN BUT WAS INTACT. THEREFORE, THE PHYSICIAN ADVANCED A GUIDEWIRE THROUGH THE LANTERN AND THE LANTERN WAS REMOVED OUT FROM THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, ADDITIONAL RUBY COILS, AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624751 ↗
• MalfunctionNov 22, 2021Positioning Problem; Positioning Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL 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. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO POD COILS. AFTER ADVANCING THE NEXT POD COIL INTO THE TARGET LESION, THE LANTERN KICKED OUT. IT WAS ALSO REPORTED THAT THE POD COIL WOULD NOT TAKE ITS INTENDED SHAPE IN THE LESION AFTER SEVERAL ATTEMPTS. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. WHILE ATTEMPTING TO IMPLANT A SMALLER-SIZED POD COIL, THE LANTERN KICKED BACK SEVERAL TIMES; HOWEVER, THE PHYSICIAN WAS STILL ABLE TO IMPLANT THE POD COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858017 ↗
• MalfunctionJul 1, 2021Material Deformation; Material Deformation

  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 12097698 ↗
• MalfunctionApr 20, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, POD COILS, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS, CALCIFIED, AND NARROWED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT RUBY COIL THROUGH THE MIDDLE OF THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE AND SUBSEQUENTLY, THE RUBY COIL BECAME STUCK IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE RUBY COIL WAS REMOVED FROM THE PATIENT, AND SUBSEQUENTLY, THE RUBY COIL WAS REMOVED FROM THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME RUBY COIL, FIVE ADDITIONAL RUBY COILS, AND TWO POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11698429 ↗
• MalfunctionApr 14, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTIC ANEURYSM (AAA) SAC USING POD PACKING COILS (POD PCS), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO POD PCS IN THE TARGET LOCATION. SUBSEQUENTLY, THE NEXT POD PC BECAME STUCK INSIDE THE LANTERN AFTER ADVANCING TO A CERTAIN POINT AND WOULD NOT RETRACT. IT WAS REPORTED THE PHYSICIAN HAD ADVANCED THE DIAGNOSTIC CATHETER WITHOUT A WIRE AND HAD MANIPULATED THE LANTERN WITHOUT A WIRE. WHEN ATTEMPTING TO PULL THE POD PC BACK, THE POD PC UNINTENTIONALLY DETACHED IN THE LANTERN. THEREFORE, THE DETACHED POD PC AND LANTERN WERE REMOVED TOGETHER. THE LANTERN WAS INSPECTED, AND THE HOSPITAL STAFF NOTICED THE LANTERN WAS KINKED AT THE DISTAL SHAFT, AROUND THE AREA WHERE THE POD PC WAS GETTING STUCK. THE PROCEDURE WAS COMPLETED USING TWO 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 11668439 ↗
• MalfunctionMar 27, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ESOPHAGEAL VARICES USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A NON-PENUMBRA GLIDE CATHETER. DURING THE PROCEDURE, WHILE PLACING THE TIP OF THE LANTERN INTO THE HUB OF THE GLIDE CATHETER WITHOUT A WIRE, THE TIP OF THE LANTERN BECAME KINKED. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND WAS ABLE TO ADVANCE A NEW LANTERN WITH A GLIDE WIRE THROUGH THE GLIDE CATHETER. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579603 ↗
• MalfunctionJan 13, 2021Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERAL VESSELS USING PACKING COIL LPS, POD PACKING COILS (POD PCS), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO LP COILS IN THE TARGET LOCATION WITH THE LANTERN. WHEN LOADING THE SUBSEQUENT COIL, A PACKING COIL LP, INTO THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL LP KINKED. THE PACKING COIL LP WAS THEN REMOVED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE SUCCESSFULLY USING A NEW PACKING COIL LP AND THE SAME LANTERN. HOWEVER, THE PHYSICIAN EXPERIENCED RESISTANCE LOADING THE SUBSEQUENTLY POD PACKING COIL AND TWO PACKING COIL LPS. THE POD PACKING COIL AND PACKING COIL LPS WERE THEN REMOVED. AT THIS POINT, THE PHYSICIAN REMOVED THE LANTERN TO VISUALLY INSPECT THE LANTERN AND OBSERVED A KINK AT THE MIDSHAFT. THEREFORE, THE LANTERN WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL LP AND NON-PENUMBRA MICROCATHETERS. 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 11166867 ↗
• MalfunctionDec 16, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA ANGLED DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO TAKE DOWN A VARIX WITHOUT ISSUE USING THE LANTERN. SUBSEQUENTLY, THE LANTERN WAS REMOVED TO DO A VENOGRAM OF THE PORTAL SYSTEM TO LOCATE ADDITIONAL VARICES. ONCE THE ADDITIONAL VARICES WERE LOCATED, THE LANTERN WAS REINTRODUCED OVER A 0.016 WIRE. WHILE ADVANCING THE LANTERN TO THE NEW EMBOLIZATION LOCATION, THE PHYSICIAN NOTICED THE LANTERN WAS KINKED AND BROKEN. THEREFORE, THE LANTERN WAS REMOVED BY PULLING IT OUT. IT IS UNKNOWN WHERE THE KINK/ BREAK OCCURRED ON THE LANTERN, BUT THE AREA OF THE BREAK DID NOT ENTER THE DIAGNOSTIC CATHETER. IT IS ALSO UNKNOWN IF THE DAMAGE TO THE LANTERN OCCURRED WHILE ADVANCING INTO THE DIAGNOSTIC CATHETER OR IF IT OCCURRED WHILE REMOVING THE LANTERN AFTER THE FIRST EMBOLIZATION. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW STRAIGHT CATHETER. 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 11023750 ↗
• MalfunctionDec 5, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT THORACIC ARTERY (ITA) USING RUBY COILS, LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA ANGIO CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN INTO THE DISTAL PORTION OF THE ANEURYSM. NEXT, WHILE ADVANCING A RUBY COIL THROUGH THE MIDDLE OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE RUBY COIL WAS RETRACTED, AND THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME RUBY COIL AND ADDITIONAL RUBY COILS. 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 10953265 ↗
• MalfunctionNov 16, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING POD COILS AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH A LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN THEN ATTEMPTED TO RETRACT AND ADVANCE THE POD COIL BUT IT WOULD GO FURTHER; THEREFORE, THE LANTERN AND POD COIL WERE REMOVED. THE PHYSICIAN THEN INSERTED A NEW LANTERN IN THE PATIENT AND ATTEMPTED TO ADVANCE THE SAME POD COIL THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL AND THE SECOND 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 10841917 ↗
• MalfunctionNov 11, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ANEURYSM OFF OF THE AORTA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), RUBY COILS, AND A GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED TWO RUBY COILS IN THE TARGET VESSEL USING THE LANTERN. AFTER REMOVING THE LANTERN FROM THE PATIENT, THE PHYSICIAN NOTICED THAT IT WAS BROKEN. THEREFORE, THE LANTERN WAS NO LONGER USED. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN AND THE SAME GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10821038 ↗
• MalfunctionOct 16, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PERFORMED AN AUTOMATED POWER INJECTION THROUGH THE LANTERN THAT WAS ADVANCED INTO THE PROXIMAL GASTRODUODENAL ARTERY. AFTER THE INJECTION THE PHYSICIAN FLUSHED THE LANTERN AND NOTICED THAT THE PROXIMAL END OF THE LANTERN SPLIT AND WAS LEAKING. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE A GUIDEWIRE THROUGH THE LANTERN TO MAINTAIN ACCESS TO THE VESSEL BUT WAS UNSUCCESSFUL; THEREFORE, THE LANTERN WAS REMOVED. 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; No Consequences Or Impact To Patient

  MAUDE report 10693700 ↗
• MalfunctionAug 19, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS AND LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN. SUBSEQUENTLY, THE RUBY COIL WAS RETRACTED. THE PHYSICIAN THEN REMOVED THE LANTERN AND FOUND THE DISTAL TIP TO BE KINKED. THE PROCEDURE WAS COMPLETED USING THE SAME RUBY COIL WITH ADDITIONAL RUBY COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10428651 ↗
• MalfunctionJun 10, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), ANGIOGRAPHIC CATHETER, AND NON-PENUMBRA COILS. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE ANGIOGRAPHIC CATHETER, FOLLOWED BY TWO COILS IN THE TARGET VESSEL. NEXT, WHILE ADVANCING THE LANTERN THROUGH PROXIMAL END OF THE ANGIOGRAPHIC CATHETER, THE LANTERN BECAME STUCK; THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN, THE SAME ANGIOGRAPHIC CATHETER, FIVE RUBY COILS, AND TWO ADDITIONAL NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138593 ↗
• MalfunctionFeb 7, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE INTERNAL ILIAC ARTERIES (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND NON-PENUMBRA CATHETER. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS, NARROW, AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE LANTERN THROUGH THE CATHETER IN THE TARGET VESSEL, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, THEY WERE REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER LANTERN AND THE SAME CATHETER. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9683587 ↗
• MalfunctionDec 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA SHEATH, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE MICROCATHETER INTO THE LANTERN APPROXIMATELY 30 CM PAST THE HUB. THE LANTERN WAS THEN REMOVED AND FLUSHED; HOWEVER, THE SAME ISSUE OCCURRED UPON RE-ADVANCEMENT OF THE MICROCATHETER. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN, THE SAME MICROCATHETER, AND THE SAME SHEATH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9483118 ↗
• MalfunctionOct 22, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT AND LEFT OVARIAN VEINS USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT FOUR RUBY COILS INTO THE RIGHT OVARIAN VEIN USING THE LANTERN AND A NON-PENUMBRA SHEATH. THE PHYSICIAN THEN ADVANCED THE DEVICES INTO THE LEFT OVARIAN VEIN. IT WAS REPORTED THAT ACCESSING THIS VESSEL WAS CHALLENGING. HOWEVER, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT TWO RUBY COILS INTO THE LEFT OVARIAN VEIN. UPON ADVANCEMENT OF THE NEXT RUBY COIL HALFWAY OUT OF THE LANTERN AND INTO THE PATIENT'S VESSEL, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED FROM THE PATIENT BY HAND. UPON REMOVAL OF THE LANTERN, THE PHYSICIAN NOTICED A SMALL KINK BETWEEN THE TWO MARKERS ON THE DISTAL END. ANOTHER LANTERN WAS THEN OPENED AND USED TO COMPLETE THE PROCEDURE. WHILE THE TECHNICIAN WAS PREPARING TWO ADDITIONAL RUBY COILS FOR USE, THE RUBY COILS BECAME KINKED UPON REMOVAL FROM THEIR PACKAGING HOOPS. THEREFORE, THE RUBY COILS WERE NOT USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL RUBY COILS. THERE WAS NO RE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9219622 ↗
• MalfunctionSep 5, 2019Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING PENUMBRA COIL 400S AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PC400 COILS INTO THE TARGET LOCATION USING THE LANTERN. DURING ADVANCEMENT OF THE NEXT PC400 THROUGH THE MIDDLE OF THE LANTERN, IT WAS REPORTED THAT THE PC400 UNINTENTIONALLY DETACHED. THE LANTERN AND PC400 WERE REMOVED TOGETHER FROM THE PATIENT. UPON REMOVAL, THE PHYSICIAN FOUND THAT THE LANTERN WAS BROKEN AT THE PROXIMAL PART. THEREFORE, THE DEVICES WERE NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING FOUR NEW PC400 COILS AND A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8967162 ↗
• MalfunctionJun 26, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA COIL 400S AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN AND A NON-PENUMBRA GUIDE CATHETER WERE PLACED INTO THE TARGET VESSEL. UPON ADVANCEMENT OF THE PC400 COIL OVER THE HUB OF THE LANTERN, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE AND DECIDED TO FLUSH THE LANTERN. HOWEVER, WHEN THE PC400 WAS ADVANCED AGAIN, THE SAME RESISTANCE OCCURRED. THE PHYSICIAN THEN DECIDED TO REMOVE THE PC400 AND THE LANTERN AND COMPLETED THE PROCEDURE USING A NEW LANTERN AND THREE ADDITIONAL PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737229 ↗
• MalfunctionMar 21, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO COILS USING THE LANTERN. IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED SOME KICK BACK WHILE ADVANCING THE SECOND COIL; HOWEVER, THE COIL WAS SUCCESSFULLY PLACED. THE PHYSICIAN HAD LOST ACCESS AND, THEREFORE, DECIDED TO REMOVE THE LANTERN. WHILE RETRACTING, THE LANTERN SNAPPED IN HALF OUTSIDE OF THE PATIENT'S BODY. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439446 ↗
• MalfunctionFeb 26, 2019Material Puncture/Hole; Material Puncture/Hole

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL ARTERIOVENOUS FISTULA USING POD PACKING COILS (POD PCS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE PENUMBRA COIL 400S (PC 400) USING THE LANTERN. THE PHYSICIAN THEN FELT RESISTANCE APPROXIMATELY FIVE CENTIMETERS FROM THE DISTAL TIP OF THE LANTERN WHILE ADVANCING A POD PC. THEREFORE, THE LANTERN AND POD PC WERE REMOVED, AND UPON REMOVAL, IT WAS FOUND THAT THE POD PC HAD PUNCTURED THROUGH THE LANTERN. THE PROCEDURE WAS THEN COMPLETED USING A NEW LANTERN WITH A NEW POD PC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369933 ↗
• MalfunctionJan 17, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING A RUBY COIL OUT OF THE TIP OF THE LANTERN AND; THEREFORE, THE RUBY COIL AND LANTERN WERE REMOVED. THE HOSPITAL STAFF THEN NOTICED THAT THE LANTERN WAS KINKED 1 CM FROM THE DISTAL TIP. THE RUBY COIL WAS ACCIDENTALLY THROWN AWAY AND; THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256466 ↗
• MalfunctionDec 18, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE TIP OF THE LANTERN WAS ACCIDENTALLY KINKED WHILE BEING ADVANCED INTO THE DIAGNOSTIC CATHETER. THEREFORE, THE LANTERN WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW MICROCATHETER AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8174335 ↗
• MalfunctionAug 17, 2018Failure to Advance; Material Deformation; Failure to Advance; 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 UNABLE TO ADVANCE A RUBY COIL THROUGH THE LANTERN AND, THEREFORE, THE LANTERN AND RUBY COIL WERE REMOVED. UPON REMOVAL, THE LANTERN WAS FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER, THE SAME RUBY COIL, AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7795379 ↗