POD RBYPOD6-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 148 adverse event reports that list this exact device (DI 00814548019611), received between Jul 19, 2018 and Jan 21, 2026 — classified as 2 injuries, 146 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (94 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 148 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL BLEED (GI BLEED) IN THE GASTRODUODENAL ARTERY (GDA) USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. A SNARE WAS USED IN AN ATTEMPT TO REMOVE THE COIL BUT WAS UNSUCCESSFUL. THE PHYSICIAN ADVANCED THE COIL TO THE TARGET LOCATION AND PARTIALLY INTO THE COMMON HEPATIC ARTERY BY FLUSHING, WITH GUIDEWIRE AND CATHETER SUPPORT. THE PHYSICIAN DETERMINED THAT LEAVING THE COIL IN THE COMMON HEPATIC ARTERY WAS ACCEPTABLE. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THAT THE PATIENT HAD A REPLACED RIGHT HEPATIC ARTERY AND THAT THE LIVER WAS FINE. THE PROCEDURE WAS COMPLETED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24140989 ↗
• MalfunctionNov 21, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GDA USING POD COILS, RUBY COILS, PACKING COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING POD COIL THROUGH THE MICROCATHETER THE HOSPITAL TECHNICIAN EXPERIENCED RESISTANCE. WHILE RETRACTING THE POD COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. A NEW MICROCATHETER WAS OPENED AND MULTIPLE PACKING AND RUBY COILS WERE PLACED IN THE TARGET VESSEL. WHILE ADVANCING A RUBY COIL INTO THE TARGET VESSEL, THE COIL WAS TOO LARGE AND WOULD NOT FIT IN THE VESSEL. WHILE RETRACTING THE RUBY COIL, THE HOSPITAL TECHNICIAN KINKED THE PUSHER ASSEMBLY. THE RUBY COIL WAS REMOVED. WHILE ADVANCING A NEW RUBY COIL INTO THE TARGET VESSEL, THE COIL WOULD NOT FULLY ENTER THE VESSEL, AND THE RUBY COIL WAS RETRACTED. MULTIPLE ATTEMPTS WERE MADE TO RE-ADVANCE THE COIL INTO THE VESSEL; HOWEVER, THE HOSPITAL TECHNICIAN KINKED THE RUBY COILS PUSHER ASSEMBLY. THEREFORE, THE RUBY COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH PACKING 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 23623480 ↗
• MalfunctionSep 17, 2025Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION AND REPORTED THAT THE COIL WAS NOT TAKING ITS INTENDED SHAPE DESPITE RETRACTING AND RE-ADVANCING THE POD COIL A FEW TIMES. THE PHYSICIAN THEN DETERMINED THAT THE POD COIL WAS TOO LONG AND DECIDED TO REMOVE IT. WHILE RETRACTING THE POD COIL, IT UNINTENTIONALLY DETACHED WHEN THE COIL WAS PARTIALLY IN THE PATIENT AND PARTIALLY WITHIN THE MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PUSH THE DETACHED POD COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING ANOTHER PENUMBRA COIL (UNKNOWN) 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 23079134 ↗
• MalfunctionAug 4, 2025Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, PACKING COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA BASE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD COIL AND THREE PACKING COILS IN THE TARGET VESSEL. WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL PUSHER ASSEMBLY FRACTURED, AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN USED A SYRINGE TO ASPIRATE THE DETACHED POD COIL AND THE MICROCATHETER FROM THE PATIENT. 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 22709868 ↗
• MalfunctionJul 22, 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 COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE DISTAL LENGTH OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE REMOVING THE POD COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS REPORTED THAT THE POD COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW POD 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 22568304 ↗
• MalfunctionJun 26, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING A POD COIL TO THE TARGET LOCATION, THE PHYSICIAN NOTICED IT WAS TOO LONG FOR THE VESSEL AND DECIDED TO REMOVE THE COIL. WHILE RETRACTING THE POD COIL, THE COIL BECAME STUCK IN THE LANTERN AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND TWO NEW RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340177 ↗
• MalfunctionMay 2, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A MICROCATHETER, AND A BASE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD8 INTO THE TARGET LOCATION. THE PHYSICIAN THEN ADVANCED A POD6 TO THE TARGET LOCATION. NEXT, THE PHYSICIAN REALIZED THAT THE MICROCATHETER WAS NOT IN ITS INTENDED LOCATION AS THE HOSPITAL STAFF HAD RETRACTED THE MICROCATHETER TO THE ILIAC ARTERY. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER. WHILE RETRACTING THE POD6 BACK INTO THE MICROCATHETER, THE POD6 UNINTENTIONALLY DETACHED WITHIN THE BASE CATHETER AND THE SPLENIC ARTERY. A SNARE DEVICE WAS USED TO REMOVE THE POD6 AND WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED A GUIDEWIRE TO TRAP THE DETACHED POD6. THE BASE CATHETER CONTAINING THE DETACHED POD6 AND THE GUIDEWIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE FINAL ANGIOGRAM CONFIRMED THAT THE VESSEL WAS SUCCESSFULLY EMBOLIZED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT. IT WAS REPORTED THAT THE UNINTENTIONAL DETACHMENT OF THE POD6 WAS DUE TO THE MICROCATHETER NOT BEING IN ITS CORRECT POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953601 ↗
• MalfunctionFeb 25, 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 POD COILS, POD PACKING COILS (PACKING COIL), A GUIDING CATHETER, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHILE INSERTING THE FIRST POD COIL INTO THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL AT THE MID-SHAFT OF THE MICROCATHETER AND WAS UNABLE TO ADVANCE THE COIL FURTHER. AFTER ADVANCING AND RETRACTING THE POD COIL WITHIN THE MICROCATHETER SEVERAL TIMES, THE PHYSICIAN OBSERVED UNDER FLUOROSCOPY THAT THE POD COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING POD COILS, PACKING 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 21463154 ↗
• MalfunctionOct 11, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED SLIGHT RESISTANCE WHILE ADVANCING THE POD COIL TOWARDS THE TARGET LOCATION. WHILE ATTEMPTING TO RETRACT THE POD COIL TO RE-POSITION A LOOP, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD COIL WAS NOT MOVING. THE PHYSICIAN THEN REALIZED THAT THE POD COIL HAD UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PUSHER ASSEMBLY OF THE POD COIL TO PUSH THE REMAINING PART OF THE COIL INTO THE TARGET VESSEL AND SUCCESSFULLY IMPLANTED THE POD COIL. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (PACKING COIL) 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 20433049 ↗
• MalfunctionSep 27, 2024Physical 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 COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE POD COIL STOPPED ADVANCING. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED. AFTER REMOVAL, THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED AND THE POD COIL WAS FLUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING TEN 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 20318128 ↗
• MalfunctionSep 10, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING POD COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A POD PACKING COIL (PACKING COIL). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED ONE POD COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING ANOTHER POD COIL THROUGH THE DISTAL LENGTH OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK WITHIN THE LANTERN. WHILE REMOVING THE POD COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PHYSICIAN THEN ADVANCED A NON-PENUMBRA MICROCATHETER INTO THE TARGET VESSEL. WHILE ADVANCING THE PACKING COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED, AND THE COIL UNRAVELED AND UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20184441 ↗
• MalfunctionJul 22, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THE POD COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS ALSO REPORTED THAT THE PHYSICIAN DECIDED TO SWITCH TO A NEW MICROCATHETER. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 19797473 ↗
• MalfunctionFeb 12, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR GLUTEAL ARTERY (IGA) USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL BECAME STUCK. WHILE MAKING ANOTHER ATTEMPT TO ADVANCE THE POD COIL, THE PHYSICIAN FRACTURED THE PUSHER ASSEMBLY AND THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE POD COIL WAS REMOVED FROM THE PATIENT. THE POD COIL WAS THEN FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL 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 18691982 ↗
• MalfunctionMar 27, 2023Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. NEXT, THE PHYSICIAN ADVANCED A NEW POD COIL INTO THE VESSEL; HOWEVER, WHILE ATTEMPTING TO REPOSITION THE POD COIL, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL, POD PACKING COIL (POD PC), 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 16618287 ↗
• MalfunctionJan 3, 2023Failure to Fold; Physical Resistance/Sticking; Premature Separation; Failure to Fold; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE FIRST POD COIL IN THE MIDDLE OF THE MICROCATHETER; HOWEVER, THE PHYSICIAN CONTINUED TO ADVANCE THE POD COIL AGAINST RESISTANCE. AFTER THE POD COIL WAS ADVANCED INTO THE TARGET LOCATION, IT WAS REPORTED THAT THE POD COIL DID NOT TAKE ITS INTENDED SHAPE. WHILE REMOVING THE POD COIL, RESISTANCE WAS ENCOUNTERED AND, SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER TO IMPLANT A TOTAL OF THIRTEEN RUBY COILS AND POD COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090493 ↗
• MalfunctionDec 27, 2022Fracture; Premature Separation; Fracture; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD COILS, AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL INTO THE TARGET LOCATION, THE PHYSICIAN FRACTURED THE PUSHER ASSEMBLY OF THE POD COIL. THEREFORE, THE POD COIL WAS REMOVED. NEXT, WHILE ADVANCING A NEW POD COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THE PREVIOUS POD COIL DETACHED IN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE NEW POD COIL AND RESHEATHED IT. THE PHYSICIAN THEN REMOVED THE LANTERN CONTAINING THE DETACHED POD COIL USING SYRINGE ASPIRATION. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND THE RESHEATHED POD COIL. THERE WAS NO ADVERSE EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052384 ↗
• MalfunctionDec 16, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD COILS, A NON-PENUMBRA MICROCATHETER, AND AN ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD COIL IN THE MIDDLE OF THE MICROCATHETER AND THE COIL BECAME STUCK. UPON RETRACTION, RESISTANCE WAS ALSO ENCOUNTERED AND, SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE MIDDLE OF THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE POD COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER TO SUCCESSFULLY IMPLANT SEVEN RUBY COILS INTO THE TARGET LOCATION, AND A STENT-GRAFT WAS ALSO USED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998754 ↗
• MalfunctionNov 2, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, BUT WAS ABLE TO ADVANCE THE POD COIL INTO THE TARGET VESSEL. SUBSEQUENTLY, THE PHYSICIAN NOTICED THAT THE POD COIL WOULD NOT FORM IN THE TARGET VESSEL AND DECIDED TO PULL THE POD COIL BACK. WHILE RETRACTING THE POD COIL, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITH HALF OF THE POD COIL IN THE TARGET VESSEL AND THE OTHER HALF IN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714394 ↗
• MalfunctionNov 1, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE POD COIL THROUGH THE MICROCATHETER AND INTO THE TARGET VESSEL. HOWEVER, THE POD COIL WAS NOT TAKING ITS INTENDED SHAPE. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE POD COIL TO REPOSITION IT. WHILE RETRACTING THE POD COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A SYRINGE TO SUCCESSFULLY FLUSH THE DETACHED POD COIL INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING POD PACKING COILS (POD PCS) 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 15705603 ↗
• MalfunctionOct 17, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LUMBAR ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE FIRST POD COIL THROUGH THE MIDDLE OF THE LANTERN AND THE COIL BECAME STUCK. WHILE ATTEMPTING TO REMOVE THE POD COIL, IT UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, THREE OTHER 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 15615076 ↗
• MalfunctionJul 25, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING A POD COIL, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL OUT OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND SUBSEQUENTLY, THE POD COIL BECAME STUCK AT APPROXIMATELY ONE CENTIMETER OUTSIDE OF THE LANTERN. THE PHYSICIAN THEN DECIDED TO RETRACT THE POD COIL. WHILE RETRACTING THE POD COIL, IT UNINTENTIONALLY DETACHED INSIDE OF THE LANTERN. NEXT, THE PHYSICIAN ATTEMPTED TO PUSH THE POD COIL INTO THE TARGET VESSEL USING A .025 GUIDEWIRE. HOWEVER; THE ATTEMPT WAS UNSUCCESSFUL. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL POD COILS, FOUR POD PACKING COILS (POD PC), AND A NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15094907 ↗
• MalfunctionJun 30, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A SMALL BRANCH OFF THE SUPERIOR MESENTERIC ARTERY (SMA) USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE LANTERN TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. SUBSEQUENTLY, THE PHYSICIAN FLUSHED THE LANTERN. WHILE ADVANCING THE POD COIL THROUGH THE LANTERN AGAIN, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. IT WAS ALSO REPORTED THE LANTERN WAS FLUSHED IN BETWEEN COILS. THE PROCEDURE WAS COMPLETED USING ANOTHER POD 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 14880641 ↗
• MalfunctionJun 22, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY USING POD COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A POD COIL INTO THE LANTERN. UPON REMOVAL, THE POD COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN TO IMPLANT ANOTHER POD COIL OF THE SAME SIZE AND THREE POD PACKING COILS (POD PCS). THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14781297 ↗
• MalfunctionJun 10, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A LANTERN DELIVERY MICROCATHETER, POD COILS, A NON-PENUMBRA CATHETER, AND A NON-PENUMBRA GUIDE SHEATH. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE LANTERN INTO THE CATHETER AND REPORTED THAT IT BECAME STUCK INSIDE. THEREFORE, THE LANTERN WAS REMOVED. A NEW LANTERN WAS USED TO SUCCESSFULLY IMPLANT A POD COIL INTO THE TARGET LOCATION. WHILE ADVANCING THE NEXT POD COIL, IT UNINTENTIONALLY DETACHED IN THE LANTERN HUB. THEREFORE, THE LANTERN CONTAINING THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN, SAME CATHETER, AND GUIDE SHEATH TO IMPLANT FOUR RUBY COILS, THREE POD PACKING COILS (POD PCS), TWO POD COILS, AND THREE NON-PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654750 ↗
• MalfunctionJun 7, 2022Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE AORTA ARTERY USING POD COILS, POD PACKING COILS (POD PC), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, AFTER ADVANCING A POD COIL AS THE FIRST COIL APPROXIMATELY SEVERAL CENTIMETERS OUT THE DISTAL END OF THE LANTERN, THE PHYSICIAN NOTICED THE POD WOULD NOT ADVANCE ANY FURTHER AND DECIDED TO REMOVE THE POD COIL. HOWEVER, WHILE RETRACTING THE POD COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND KINKED THE PROXIMAL END OF THE POD COIL. CONSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED WITH THE MAJORITY PORTION OF THE DETACHED COIL INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN USED A HEMOSTAT TO CLAMP THE LANTERN CONTAINING THE DETACHED POD COIL AND REMOVED BOTH THE LANTERN AND COIL TOGETHER AS A UNIT. THE PHYSICIAN THEN INSERTED A NEW LANTERN AND PLACED A NEW POD COIL. SUBSEQUENTLY, THE PHYSICIAN INSERTED A POD PC INTO THE LANTERN; HOWEVER, WHILE ADVANCING A POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND, CONSEQUENTLY, THE PHYSICIAN KINKED THE PUSHER ASSEMBLY OF THE POD PC. THEREFORE, THE POD POC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW POD PCS AND THE SAME LANTERN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14621832 ↗