POD RBYPODJ30-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00814548017655), received between Nov 16, 2017 and Sep 10, 2026 — classified as 12 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (61 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 132 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the gastroduodenal artery (GDA) using a POD Packing Coil (Packing Coil) and a Lantern Delivery Microcatheter (Lantern). It was reported that the Lantern was flushed prior to using the Packing Coil. Resistance was experienced while advancing the Packing Coil. The physician decided to retract the coil. While retracting the Packing Coil, the Packing Coil unintentionally detached within the Lantern. The Lantern containing the detached embolization coil was removed.The procedure was completed using another Packing Coil and the same Lantern. There was no report of an adverse effect to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716056 ↗
• MalfunctionJun 24, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PACKING COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN SUCCESSFULLY PLACED NON-PENUMBRA COILS AND PACKING COILS INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT PACKING COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND DECIDED TO RETRACT THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE AFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25606422 ↗
• MalfunctionMar 11, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A COLLATERAL VESSEL USING A PACKING COIL XL, POD PACKING COILS (PACKING COILS), AND A NON-PENUMBRA CATHETER (4F). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PACKING COIL XL INTO THE VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE PACKING COIL XL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE CATHETER. THE CATHETER CONTAINING THE EMBOLIZATION COIL WAS REMOVED. THE PHYSICIAN OPENED A LANTERN DELIVERY MICROCATHETER (LANTERN) AND ADVANCED A PACKING COIL INTO THE TARGET VESSEL. WHILE REPOSITIONING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE VESSEL. A SNARE DEVICE WAS USED TO REMOVE THE DETACHED EMBOLIZATION COIL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW PACKING COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567825 ↗
• MalfunctionDec 18, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRIC VARICES USING A POD PACKING COIL (PACKING COIL), RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL IN THE TARGET LOCATION. WHILE ADVANCING A PACKING COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THE PACKING COIL WAS TOO LARGE FOR THE SPACE AND DECIDED TO REPOSITION THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE MICROCATHETER AND PARTIALLY IN THE VESSEL. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A NEW PACKING COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845141 ↗
• MalfunctionNov 17, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COILS), RUBY COILS, AND A GUIDING SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THREE RUBY COILS AND SIX PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MID-SHAFT OF THE LANTERN AND WAS UNABLE TO ADVANCE THE PACKING COIL ANY FURTHER. UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE PACKING COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23576357 ↗
• MalfunctionSep 12, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PACKING COIL), A RUBY COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL AND TWO PACKING COILS IN THE TARGET LOCATION. WHILE ADVANCING ANOTHER PACKING COIL INTO THE TARGET LOCATION USING THE MICROCATHETER, THE PHYSICIAN WAS NOT SATISFIED WITH THE WAY THE PACKING COIL WAS TAKING SHAPE AND DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND 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 23041083 ↗
• MalfunctionAug 28, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK USING A RUBY COIL, A POD PACKING COIL (PACKING COIL), A LANTERN DELIVERY MICROCATHETER, A NON-PENUMBRA GLIDE CATHETER, AND A SHEATH (6FR). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A RUBY COIL IN THE TARGET LOCATION. WHILE ADVANCING A PACKING COIL INTO THE TARGET LOCATION, THE EMBOLIZATION COIL BECAME TANGLED WITH THE PREVIOUSLY PLACED COIL. WHILE RETRACTING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE LUMBAR ARTERY EXTENDING TO THE INTERNAL ILIAC ARTERY AND PARTIALLY WITHIN THE LANTERN. THE PHYSICIAN ATTEMPTED TO PUSH THE REMAINING COIL INTO THE VESSEL USING THE COIL'S PUSHER ASSEMBLY, BUT THE COIL WOULD NOT MOVE. SALINE WAS INJECTED INTO THE LANTERN TO PUSH THE DETACHED COIL INTO THE TARGET VESSEL; HOWEVER, IT WOULD NOT MOVE. THE LANTERN WAS REMOVED FROM THE PATIENT AND A GUIDE WIRE WAS ADVANCED THROUGH THE GLIDE CATHETER WHICH WAS ALREADY POSITIONED WITHIN THE LUMBAR ARTERY NEAR THE TARGET LOCATION. THE PHYSICIAN ATTEMPTED TO PUSH THE COIL INTO THE VESSEL USING THE GUIDEWIRE BUT THE COIL WOULD NOT MOVE. THE PHYSICIAN THEN REMOVED THE GLIDE CATHETER UNDER

  Patient problems: Foreign Body In Patient

  MAUDE report 22917075 ↗
• MalfunctionJun 18, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COIL), A NON-PENUMBRA COIL, A INTERMEDIATE CATHETER AND A GUIDING CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN THROUGH THE INTERMEDIATE CATHETER AND THE GUIDING CATHETER, AND SUCCESSFULLY IMPLANTED THE NON-PENUMBRA COIL AND ONE OF THE PACKING COILS INTO THE TARGET VESSEL. WHILE ATTEMPTING TO INSERT ANOTHER PACKING COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL COULD NOT BE ADVANCED BEYOND THE MID-SHAFT OF THE LANTERN. THEREFORE, THE PACKING COIL WAS RETRACTED FROM THE LANTERN. AFTER FLUSHING THE LANTERN, THE PHYSICIAN RE-INSERTED THE LANTERN AND ATTEMPTED TO ADVANCE THE SAME PACKING COIL. HOWEVER, STRONGER RESISTANCE WAS EXPERIENCED, AND THE PACKING COIL COULD NOT BE ADVANCED BEYOND THE MID-SHAFT OF THE LANTERN. IT WAS REPORTED THAT THE PACKING COIL WAS UNINTENTIONALLY DETACHED, BELIEVED TO HAVE DETACHED WHILE BEING PULLED BACK. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287060 ↗
• MalfunctionJun 12, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD PACKING COIL (PACKING COIL), AND NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE PACKING COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE PACKING COIL, THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199374 ↗
• MalfunctionMar 27, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD PACKING COIL (PACKING COIL), A POD COIL, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE POD COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE PACKING COIL THROUGH THE DISTAL LENGTH OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. AS THE PHYSICIAN WAS RETRACTING THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713569 ↗
• MalfunctionMar 4, 2025Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD PACKING COILS (PACKING COILS), A LANTERN DELIVERY MICROCATHETER (LANTERN), NON-PENUMBRA COILS, AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS AND TWO PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. NEXT, ANOTHER PACKING COIL WAS ADVANCED INTO THE TARGET VESSEL; HOWEVER, THE PACKING COIL WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN THEN MADE SEVERAL ATTEMPTS TO REMOVE THE PACKING COIL FROM THE PATIENT. WHILE MAKING AN ATTEMPT TO RETRACT THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT, AND THE PACKING COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21520774 ↗
• MalfunctionFeb 26, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT SUBCLAVIAN ARTERY USING A POD COIL, POD PACKING COILS (PACKING COIL), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE ADVANCING THE POD COIL INTO THE TARGET LOCATION. TO ACHIEVE BETTER PACKING, THE PHYSICIAN REPOSITIONED THE LANTERN MULTIPLE TIMES. WHILE ADVANCING AND RETRACTING THE POD COIL, THE POD COIL UNINTENTIONALLY DETACHED. THE POD COIL WAS REMOVED FROM THE PATIENT. THE SAME ISSUE OCCURRED WITH THREE ADDITIONAL POD PACKING COILS. OUT OF THE FOUR DETACHED COILS, THREE COILS WERE DETACHED IN THE LANTERN AND WERE REMOVED BY REMOVING THE LANTERN FROM THE PATIENT. IT WAS REPORTED THAT ONE OF THE FOUR COILS DETACHED PARTIALLY IN THE VESSEL AND PARTIALLY IN THE MICROCATHETER AND THAT COIL WAS SNARED OUT. IT IS UNKNOWN WHICH OF THE FOUR DETACHED COILS WAS SNARED OUT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21472182 ↗
• MalfunctionDec 6, 2024Failure to Fold; Fracture; Physical Resistance/Sticking; Failure to Fold; Fracture; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT RENAL ARTERY USING RUBY COILS, POD PACKING COILS (PACKING COIL), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, A NON-PENUMBRA SHEATH, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE RUBY COILS, PACKING COILS, AND NON-PENUMBRA COILS IN THE ANEURYSM USING THE MICROCATHETER. WHILE ADVANCING THE NEXT PACKING COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT THE PACKING COIL WAS NOT FORMING ITS INTENDED SHAPE AND REMAINED STRAIGHT. THE PHYSICIAN ATTEMPTED TO RETRACT THE PACKING COIL, BUT EXPERIENCED RESISTANCE AND THE PACKING COIL HAD FRACTURED. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE PROXIMAL FRACTURED PORTION OF THE PACKING COIL OUT FROM THE MICROCATHETER. THE PHYSICIAN THEN INJECTED SALINE TO PUSH THE DISTAL FRACTURED PORTION OF THE PACKING COIL INTO THE ANEURYSM AND DETERMINED THAT THE PACKING COIL WAS SAFELY IMPLANTED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870071 ↗
• MalfunctionNov 5, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VENO-VENOUS (VV) SHUNT OF THE PULMONARY VEINS USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COIL), AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR RUBY COILS AND SIX PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE PACKING COIL AS THE ELEVENTH COIL, THE PHYSICIAN NOTICED THE COIL WAS NOT FOLLOWING AND HAD UNINTENTIONALLY DETACHED WHEN IT WAS PARTIALLY OUT OF THE TIP OF THE LANTERN. THEREFORE, THE DETACHED PACKING COIL WAS REMOVED WITH THE LANTERN, AND THE PACKING COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS CONTINUED, AND EIGHT MORE PACKING COILS WERE SUCCESSFULLY IMPLANTED USING THE SAME MICROCATHETER. HOWEVER, ANOTHER PACKING COIL WAS ALSO NOTICED TO NOT BE FOLLOWING AND HAD UNINTENTIONALLY DETACHED WHEN ITS ENTIRE LENGTH WAS OUTSIDE OF THE MICROCATHETER. A SNARE WAS USED TO REMOVE THE DETACHED PACKING COIL FROM THE TARGET VESSEL. THE PHYSICIAN CONFIRMED THE SHUNT FLOW HAD DROPPED AND DECIDED TO END THE PROCEDURE. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606672 ↗
• MalfunctionNov 5, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A VENO-VENOUS (VV) SHUNT OF THE PULMONARY VEINS USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COIL), AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FOUR RUBY COILS AND SIX PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING THE PACKING COIL AS THE ELEVENTH COIL, THE PHYSICIAN NOTICED THE COIL WAS NOT FOLLOWING AND HAD UNINTENTIONALLY DETACHED WHEN IT WAS PARTIALLY OUT OF THE TIP OF THE LANTERN. THEREFORE, THE DETACHED PACKING COIL WAS REMOVED WITH THE LANTERN, AND THE PACKING COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS CONTINUED, AND EIGHT MORE PACKING COILS WERE SUCCESSFULLY IMPLANTED USING THE SAME MICROCATHETER. HOWEVER, ANOTHER PACKING COIL WAS ALSO NOTICED TO NOT BE FOLLOWING AND HAD UNINTENTIONALLY DETACHED WHEN ITS ENTIRE LENGTH WAS OUTSIDE OF THE MICROCATHETER. A SNARE WAS USED TO REMOVE THE DETACHED PACKING COIL FROM THE TARGET VESSEL. THE PHYSICIAN CONFIRMED THE SHUNT FLOW HAD DROPPED AND DECIDED TO END THE PROCEDURE. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606611 ↗
• MalfunctionOct 4, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PACKING COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A PACKING COIL INTO THE TARGET VESSEL USING THE LANTERN, THE PHYSICIAN NOTICED THE PACKING COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THE PACKING COIL HAD UNINTENTIONALLY DETACHED AFTER ADVANCING THE COIL INTO INTENDED VESSEL AND THE PHYSICIAN DECIDED TO LEAVE THE PACKING COIL IN PLACE. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20374143 ↗
• MalfunctionJun 21, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD COIL, POD PACKING COILS (PACKING COIL), A NON-PENUMBRA MICROCATHETER (CARRY LEON HF), AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD COIL AND ONE PACKING COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER PACKING COIL OUT OF ITS SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT CONTINUED TO ADVANCE THE PACKING COIL INTO THE MICROCATHETER. WHILE ADVANCING THE PACKING COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PULL WIRE OF THE PACKING COIL FRACTURED, AND THE PACKING COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN PULLED THE PUSHER ASSEMBLY OF THE PACKING COIL BACK; HOWEVER, IT FRACTURED. WHILE ATTEMPTING TO PULL THE PUSHER ASSEMBLY OUT OF THE MICROCATHETER, THE FRACTURED PART OF THE PUSHER ASSEMBLY SEPARATED AND ONLY THE PULL WIRE WAS REMOVED. THEREFORE, THE MICROCATHETER CONTAINING THE PACKING COIL AND FRACTURED PUSHER ASSEMBLY WERE REMOVED. IT WAS REPORTED THAT THE PACKING COIL AND FRACTURED PUSHER ASSEMBLY WERE FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR PACKING COIL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588575 ↗
• MalfunctionMar 22, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING PACKING COILS (PC), A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA CATHETER (.038), AND A GUIDEWIRE. DURING THE PROCEDURE, THE LANTERN WAS ADVANCED THROUGH A NON-PENUMBRA CATHETER INTO THE TARGET LOCATION. IT WAS REPORTED THAT ONE POD COIL WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A PC THROUGH THE LANTERN; HOWEVER, THE LANTERN KICKED BACK. UPON RE-ADVANCING, THE LANTERN WOULD NOT ADVANCE THROUGH THE NON-PENUMBRA CATHETER. IT WAS NOTED THAT THE LANTERN MAY HAVE BEEN KINKED. THEREFORE, THE PHYSICIAN RETRACTED THE PC AND NOTICED THAT THE COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE LANTERN WAS THEN REMOVED CONTAINING THE DETACHED PC. AFTER REMOVAL, THE LANTERN WAS NOTICED TO BE KINKED AT THE DISTAL END. THE LANTERN WAS ATTEMPTED TO BE FLUSHED; HOWEVER, THE DETACHED PC WAS STUCK AT THE KINKED LOCATION AND WOULD NOT FLUSH OUT. THE PROCEDURE WAS COMPLETED USING A NEW PC, A NON-PENUMBRA MICROCATHETER, AND THE SAME NON-PENUMBRA CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964359 ↗
• MalfunctionFeb 28, 2024Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (POD PC), AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND FOUR POD PCS INTO THE TARGET VESSEL USING THE LANTERN. ANOTHER COIL WAS ADVANCED TO THE TARGET VESSEL; HOWEVER, THE POD PC WOULD NOT TAKE ITS INTENDED SHAPE. AFTER SEVERAL STROKES OF PULLING THE POD PC BACK, THE POD PC UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE POD PC WAS REMOVED. IT WAS REPORTED THAT THE POD PC WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW POD PC, THE SAME 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 18803914 ↗
• MalfunctionDec 26, 2023Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (POD PC), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO RUBY COILS AND TWO POD PCS IN TARGET VESSEL USING THE LANTERN. IT WAS REPORTED THAT THE GUIDEWIRE WAS EXTENDED PAST THE TARGET VESSEL FOR SUPPORT. WHEN THE PHYSICIAN BEGAN TO REMOVE THE GUIDEWIRE, ALL OF THE PREVIOUSLY PLACED COILS THAT WERE IMPLANTED MIGRATED TO THE MAIN SPLENIC ARTERY. AFTER PERFORMING AN ANGIOGRAM, THE PHYSICIAN DECIDED TO LEAVE THE COILS IN THE MAIN SPLENIC ARTERY. 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 18393370 ↗
• MalfunctionOct 13, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT COLIC BRANCH USING A POD PACKING COILS (POD PC). DURING THE PROCEDURE, THE POD PC WAS NOT PROPERLY DEPLOYED IN THE VESSEL. IT WAS ALSO REPORTED THE POD PC WAS PARTIALLY IN THE VESSEL AND STUCK IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS CUT AND THE POD PC WAS REMOVED USING A SNARE DEVICE. 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 17935590 ↗
• MalfunctionMay 26, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A RUBY COIL, POD PACKING COILS (POD PC), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, THE PHYSICIAN WAS EXPERIENCING RESISTANCE WHILE ADVANCING THE POD PC TO THE DISTAL END OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN WENT TO RETRACT THE POD PC AND NOTICED THAT THE POD PC HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD PC AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011696 ↗
• MalfunctionMar 29, 2023Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (POD PC) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE POD PC THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD PC BECAME STUCK. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. UPON RETRACTION, THE PHYSICIAN STRETCHED AND BROKE THE POD PC BUT THE POD PC REMAINED CONNECTED TO ITS PUSHER ASSEMBLY. IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO RETRACT THE POD PC WITH ITS PUSHER ASSEMBLY. THEREFORE, THE MICROCATHETER CONTAINING THE POD PC WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW POD PC AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16640949 ↗
• MalfunctionJan 12, 2023Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (POD PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN OVER THE GUIDEWIRE INTO THE TARGET LOCATION. NEXT, THE GUIDEWIRE WAS REMOVED, AND THE PHYSICIAN ATTEMPTED TO ADVANCE A POD PC THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE POD PC WOULD NOT FULLY ADVANCE OUT THE DISTAL END OF THE LANTERN. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE POD PC; HOWEVER, WHILE RETRACTING, THE POD PC HAD UNINTENTIONALLY DETACHED AND WAS STUCK INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD PC WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN THEN PERFORMED AN X-RAY TO CONFIRM THE ENTIRE DETACHED POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND A NEW POD PC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153241 ↗
• MalfunctionDec 20, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE ABDOMINAL AORTA USING POD PACKING COILS (POD PCS) AND NON-PENUMBRA MICROCATHETERS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NINE NON-PENUMBRA COILS USING ONE MICROCATHETER AND TWO POD PCS USING THE OTHER MICROCATHETER. WHILE ADVANCING THE NEXT POD PC IN THE MIDDLE OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. UPON RETRACTION, RESISTANCE WAS ALSO ENCOUNTERED AND, SUBSEQUENTLY, THE POD PC UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED FROM THE PATIENT, AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER TO SUCCESSFULLY IMPLANT FOUR POD PCS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16019172 ↗