POD RBYPODJ60-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 355 adverse event reports that list this exact device (DI 00814548017679), received between Dec 11, 2017 and Sep 9, 2026 — classified as 17 injuries, 338 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (195 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 355 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Premature Separation

  The patient was undergoing a coil embolization procedure in the splenic artery using a POD Packing Coil (Packing Coil) and a non-Penumbra microcatheter. While advancing the Packing Coil through the microcatheter, the physician observed that the Packing Coil had unintentionally detached within the microcatheter. Consequently, the microcatheter containing the detached Packing Coil was removed from the patient.The procedure was completed using 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 50694180 ↗
• MalfunctionAug 26, 2026Premature Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461544 ↗
• MalfunctionJun 24, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERALS USING A POD PACKING COIL (PACKING COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A PACKING COIL INTO THE TARGET LOCATION USING THE LANTERN, THE LANTERN KICKED OUT OF THE VESSEL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE LANTERN BACK INTO THE VESSEL. THE PHYSICIAN STILL ATTEMPTED TO ADVANCE THE PACKING COIL INTO THE VESSEL BUT NOTICED UNDER FLUOROSCOPY THAT THE DISTAL END OF THE COIL WAS STUCK ON AN EXISTING VASCULAR PLUG. THE PHYSICIAN DECIDED TO REMOVE THE LANTERN AND PACKING COIL. WHILE RETRACTING THE PACKING COIL INTO THE LANTERN, THE PHYSICIAN WAS EXPERIENCING RESISTANCE, AND THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE AND FORCEPS TO REMOVE THE DETACHED PACKING COIL. THE PROCEDURE WAS COMPLETED USING A NEW PUSHABLE COILS 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 25606522 ↗
• MalfunctionMay 22, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. WHILE ADVANCING THE PACKING COIL TO THE TARGET LOCATION, THE PHYSICIAN EXPERIENCED RESISTANCE IN THE MID-SHAFT OF THE MICROCATHETER. UPON ATTEMPTING TO RETRACT THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING FOUR NEW 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 25260796 ↗
• MalfunctionApr 23, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (PACKING COIL), A GUIDING CATHETER, AND A GUIDEWIRE. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE GUIDING CATHETER TO THE ORIGIN OF THE IIA, THEN ADVANCED THE LANTERN THROUGH THE GUIDING CATHETER TO THE TARGET LOCATION. WHILE ADVANCING THE PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED FROM THE PATIENT AND THE DETACHED COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24968688 ↗
• InjuryDec 31, 2025Fracture; Fracture

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PACKING COIL). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PACKING COIL; HOWEVER, IT COULD NOT BE PULLED BACK, AND THE COIL BECAME DAMAGED. IT WAS REPORTED THAT PART OF THE PACKING COIL WAS LEFT IN THE PATIENT'S BODY. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23936044 ↗
• MalfunctionDec 12, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PACKING COILS INTO THE TARGET VESSEL. WHILE ADVANCING THE NEXT PACKING COIL THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN RETRACTED THE PACKING COIL AND THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED EMBOLIZATION COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER 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 23796563 ↗
• 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 POD PACKING COILS (PACKING COIL), NON-PENUMBRA COILS, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED EIGHT NON-PENUMBRA COILS AND ONE PACKING COIL INTO THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING ANOTHER PACKING COIL AT THE DISTAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHEN ATTEMPTING TO RETRACT THE COIL BACK INTO THE MICROCATHETER FOR REPOSITIONING, THE PACKING COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE PACKING COIL WAS REMOVED. NO FRAGMENT OF THE EMBOLIZATION COIL WAS LEFT IN THE PATIENT¿S VESSEL. THE PROCEDURE WAS COMPLETED USING A NEW 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 23576725 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AVM (ARTERIOVENOUS MALFORMATION) IN THE ANTERIOR TIBIAL ARTERY USING A POD COIL, POD PACKING COILS (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GLIDE CATHETER, A NON-PENUMBRA SHEATH, AND A GLIDE WIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL INTO THE TARGET VESSEL THROUGH THE LANTERN. WHILE ADVANCING A PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN. THE PHYSICIAN REMOVED THE PACKING COIL. NO DAMAGE WAS NOTED TO THE CATHETERS UNDER FLUOROSCOPY. THE PHYSICIAN ADVANCED THE SAME PACKING COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS NOTED AT THE DISTAL END OF LANTERN. THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE REMOVING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE LANTERN AND PARTIALLY IN THE TARGET VESSEL. THE PHYSICIAN INJECTED SALINE TO PUSH THE EMBOLIZATION COIL INTO THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH A SECOND PACKING COIL. WHILE REMOVING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426119 ↗
• MalfunctionOct 30, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AVM (ARTERIOVENOUS MALFORMATION) IN THE ANTERIOR TIBIAL ARTERY USING A POD COIL, POD PACKING COILS (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA GLIDE CATHETER, A NON-PENUMBRA SHEATH, AND A GLIDE WIRE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD COIL INTO THE TARGET VESSEL THROUGH THE LANTERN. WHILE ADVANCING A PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN. THE PHYSICIAN REMOVED THE PACKING COIL. NO DAMAGE WAS NOTED TO THE CATHETERS UNDER FLUOROSCOPY. THE PHYSICIAN ADVANCED THE SAME PACKING COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS NOTED AT THE DISTAL END OF LANTERN. THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE REMOVING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE LANTERN AND PARTIALLY IN THE TARGET VESSEL. THE PHYSICIAN INJECTED SALINE TO PUSH THE EMBOLIZATION COIL INTO THE ANEURYSM. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH A SECOND PACKING COIL. WHILE REMOVING THE PACKING COIL, THE EMBOLIZATION COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426106 ↗
• MalfunctionAug 8, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD COIL, A POD PACKING COIL (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA BASE CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD COIL IN THE TARGET LOCATION USING THE LANTERN. THE PHYSICIAN ADVANCED THE NEXT PACKING COIL INTO THE TARGET LOCATION AND DETERMINED THE COIL WAS TOO LONG FOR THE VESSEL AND DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PACKING COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN REMOVED THE LANTERN, AND THE DETACHED PACKING COIL BECAME STUCK INSIDE THE BASE CATHETER. THEREFORE, THE PHYSICIAN ADVANCED THE BASE CATHETER FORWARD ENOUGH TO PLACE CLAMPS ON THE BASE CATHETER AND REMOVED THE BASE CATHETER CONTAINING THE DETACHED PACKING COIL. IT WAS REPORTED THAT THE PHYSICIAN LOST ACCESS AND WAS UNABLE TO RE-CANULATE THE GDA. THE PHYSICIAN DETERMINED THE PREVIOUSLY PLACED POD COIL WAS ENOUGH TO SHUT DOWN THE GDA AND NO ADDITIONAL COILS WERE NEEDED. THERE WAS COMPLETE FLOW THROUGH THE HEPATIC ARTERY. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22758327 ↗
• MalfunctionAug 7, 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 PACKING COILS (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS HIGHLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER PACKING COIL THROUGH THE MID-SHAFT OF THE MICROCATHETER, THE PACKING COIL BECAME STUCK, AND THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE ATTEMPTING TO REMOVE THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PACKING COIL WAS FLUSHED OUT OF THE MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING 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 22743546 ↗
• MalfunctionJul 15, 2025Premature Separation; 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), A NON-PENUMBRA COIL, AND A 5F ANGIOGRAPHIC CATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THE NON-PENUMBRA COIL AND FOUR PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. AFTER ADVANCING ANOTHER PACKING COIL INTO THE TARGET LOCATION, THE COIL DID NOT FIT PROPERLY AND THE PHYSICIAN MADE SEVERAL ATTEMPTS TO REPOSITION THE COIL. WHILE RETRACTING THE PACKING COIL INTO THE LANTERN DURING A REPOSITIONING ATTEMPT, THE PACKING COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT, AND THE DETACHED COIL WAS FLUSHED OUT OF THE LANTERN. 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 22515264 ↗
• MalfunctionJun 25, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, A POD PACKING COIL (PACKING COIL), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD COIL THROUGH THE MICROCATHETER, THE POD COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE SAME ISSUE OCCURRED WITH ANOTHER POD COIL AND A PACKING COIL. THE PHYSICIAN REMOVED THE MICROCATHETER CONTAINING THE DETACHED POD COIL AND PACKING COIL RESPECTIVELY. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325716 ↗
• 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 ONE NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE PACKING COIL THROUGH THE MICROCATHETER, THE PACKING COIL STOPPED ADVANCING AT THE DISTAL END OF THE MICROCATHETER. WHILE ATTEMPTING TO REMOVE THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED WITH MOST OF THE COIL WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PUSHER ASSEMBLY MAY HAVE FRACTURED WHILE APPLYING FORCE TO ADVANCE THE COIL. THE PROCEDURE WAS COMPLETED USING 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 22195473 ↗
• MalfunctionJun 2, 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 POD PACKING COIL (PACKING COIL), A NON-PENUMBRA COIL AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE PACKING COIL THROUGH THE MICROCATHETER, THE PACKING COIL BECAME STUCK IN THE DISTAL LENGTH OF THE MICROCATHETER. UPON ATTEMPTING TO RETRIEVE THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT, AND THE POD COIL WAS REMOVED FROM THE MICROCATHETER OUTSIDE OF THE PATIENT. SUBSEQUENT CONTRAST IMAGING SHOWED THAT BLOOD FLOW HAD CEASED. NO ADDITIONAL DEVICES WERE REQUIRED AND THE PHYSICIAN THEN DECIDED TO END THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128722 ↗
• MalfunctionMay 23, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GI BLEED USING A POD PACKING COIL (PACKING COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED ONE PENUMBRA COIL IN THE TARGET VESSEL. WHILE ADVANCING A SECOND PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN WAS HAVING DIFFICULTY KEEPING THE LANTERN IN THE CORRECT POSITION. THE PHYSICIAN DECIDED TO REMOVE THE COIL. WHILE REMOVING THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079622 ↗
• MalfunctionMay 16, 2025Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PACKING COIL) AND A MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL THROUGH THE MICROCATHETER, THE PHYSICIAN KINKED THE PACKING COIL PUSHER ASSEMBLY AND THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PACKING COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036655 ↗
• MalfunctionMay 13, 2025Unraveled Material; Physical Resistance/Sticking; Premature Separation; Unraveled Material; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL ILIAC ARTERY USING A POD COILS, POD PACKING COIL (PACKING COIL)S, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE POD COIL THROUGH THE LANTERN (45 DEGREE TIP), THE PHYSICIAN EXPERIENCED RESISTANCE AND THE COIL WOULD NOT MOVE FURTHER. IT WAS NOTED THAT THE LANTERN WAS FLUSHED WITH SALINE BEFORE ADVANCING THE POD COIL. THE PHYSICIAN REMOVED THE POD COIL AND FLUSHED THE LANTERN. THE POD COIL WAS ADVANCED A SECOND TIME; HOWEVER, THE COIL WOULD NOT ADVANCE THROUGH THE LANTERN. THE POD COIL AND LANTERN WERE REMOVED. THE PHYSICIAN OPENED A NEW LANTERN (STRAIGHT TIP) AND PLACED A POD COIL AND PACKING COIL IN THE TARGET VESSEL. WHILE ADVANCING A SECOND PACKING COIL THROUGH THE LANTERN, THE PACKING COIL BECAME STUCK. WHILE ATTEMPTING TO RETRACT THE PACKING COIL INTO IT'S INTRODUCER SHEATH, THE PACKING COIL UNRAVELED AND UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED. THE PROCEDURE WAS CONSIDERED COMPLETED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015798 ↗
• MalfunctionApr 29, 2025Break; 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 PACKING COIL (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND NON-PENUMBRA COILS. IT SHOULD BE NOTED THAT THE PATIENT'S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING A PACKING COIL THROUGH THE DISTAL LENGTH OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. UPON INSPECTION, THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS FOUND TO BE DAMAGED, AND THE PACKING COIL HAD UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT, AND THE PACKING COIL WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL, 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 21930022 ↗
• MalfunctionApr 22, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ANEURYSM USING POD PACKING COILS (PACKING COIL), RUBY COILS, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE RUBY COILS INTO THE TARGET LOCATION USING THE MICROCATHETER. IT WAS REPORTED THAT THE MICROCATHETER WAS FLUSHED AFTER IMPLANTING EACH RUBY COIL. NEXT, THE PHYSICIAN ADVANCED A PACKING COIL THROUGH THE MICROCATHETER DURING THE FINAL FILLING PHASE AND REPORTED THAT THE COIL BECAME STUCK. THE PACKING COIL WAS STUCK INSIDE THE MICROCATHETER AND WHILE ATTEMPTING TO ADVANCE AND RETRACT THE PACKING COIL FOR REMOVAL, THE COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW MICROCATHETER AND A LIQUID EMBOLIC AGENT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882242 ↗
• MalfunctionMar 21, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA) USING RUBY COILS, A POD PACKING COIL (PACKING COIL), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED AND DETACHED FIVE RUBY COILS IN THE TARGET LOCATION. NEXT, AFTER ADVANCING APPROXIMATELY TEN CENTIMETERS OF A PACKING COIL INTO THE ANEURYSM, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO RETRACT THE PACKING COIL. WHILE RETRACTING, THE PACKING COIL HAD UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE LANTERN. THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED PACKING COIL INTO THE ANEURYSM USING THE PUSHER ASSEMBLY, BUT THE PACKING COIL WOULD NOT ADVANCE. THEREFORE, THE PHYSICIAN USED A SYRINGE TO ASPIRATE ON THE LANTERN AND REMOVED THE DETACHED PACKING COIL TOGETHER WITH THE LANTERN. THE PHYSICIAN PERFORMED AN IMAGE OF THE ANEURYSM AND DISCOVERED THE ANEURYSM WAS SUCCESSFULLY EMBOLIZED AND 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 21664906 ↗
• MalfunctionMar 17, 2025Premature 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 THE PACKING COIL THROUGH THE LANTERN, THE PACKING COIL BECAME STUCK, AND UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO FLUSH THE PACKING COIL OUT FROM THE LANTERN WITHOUT SUCCESS. THE PROCEDURE WAS COMPLETED USING A NEW PACKING COIL 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 21620529 ↗
• MalfunctionJan 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 LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COIL) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHEN ADVANCING THE FIRST PACKING COIL IN THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN AND WAS UNABLE TO ADVANCE IT ANY FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, IT UNINTENTIONALLY DETACHED AT THE MID-SHAFT OF 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. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PACKING COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE PACKING COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214017 ↗
• MalfunctionJan 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 LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (PACKING COIL) AND A NON-PENUMBRA SHEATH. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, WHEN ADVANCING THE FIRST PACKING COIL IN THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AT THE DISTAL END OF THE LANTERN AND WAS UNABLE TO ADVANCE IT ANY FURTHER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, IT UNINTENTIONALLY DETACHED AT THE MID-SHAFT OF 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. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE ANOTHER PACKING COIL THROUGH THE LANTERN; HOWEVER, RESISTANCE WAS ENCOUNTERED, AND THE PACKING COIL BECAME STUCK AT THE DISTAL END OF THE LANTERN. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, IT UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214015 ↗