POD RBYPODJ45-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00814548017662), received between Dec 29, 2017 and Apr 9, 2026 — classified as 10 injuries, 115 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (68 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 125 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING A POD COIL, POD PACKING COILS, A NON-PENUMBRA MICROCATHETER, AND A GUIDING CATHETER. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED ONE POD COIL AND THREE PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING AN ADDITIONAL PACKING COIL THROUGH THE INTRODUCER SHEATH AND INTO THE PROXIMAL PORTION OF THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED. WHEN ATTEMPTING TO RETRACT THE PACKING COIL, IT WAS DETERMINED THAT THE COIL HAD UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. FOLLOW-UP ANGIOGRAPHY PERFORMED THROUGH THE GUIDING CATHETER DEMONSTRATED THAT EMBOLIZATION HAD BEEN ACHIEVED TO SOME EXTENT; THEREFORE, THE PROCEDURE WAS CONCLUDED AT THAT TIME. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832096 ↗
• MalfunctionApr 9, 2026Premature 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 CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED. THE PHYSICIAN PLACED THE NON-PENUMBRA COIL AND FOUR PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN AND THE 5F CATHETER. WHILE ATTEMPTING TO REPOSITION ANOTHER PACKING COIL MULTIPLE TIMES, THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED FROM THE PATIENT AND THE COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING NEW PACKING COILS, THE SAME LANTERN, AND THE SAME 5F CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832027 ↗
• MalfunctionApr 9, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING POD PACKING COILS (PACKING COILS), NON-PENUMBRA COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO NON-PENUMBRA COILS AND A PACKING COIL INTO THE TARGET LOCATION. WHILE ATTEMPTING TO IMPLANT ANOTHER PACKING COIL, THE COIL WENT IN AN UNWANTED DIRECTION. THE PHYSICIAN WAS RETRACTING THE PACKING COIL TO RE-POSITION IT WHEN THE COIL UNINTENTIONALLY DETACHED PARTIALLY WITHIN THE SHEATH AND PARTIALLY WITHIN THE PATIENT. THE PHYSICIAN THEN USED ANOTHER NON-PENUMBRA SHEATH THROUGH A SECOND ACCESS POINT AND USED FORCEPS TO REMOVE THE DETACHED PACKING COIL. AT THIS POINT, 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 24831436 ↗
• MalfunctionFeb 23, 2026Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION TO TREAT A SPLENIC ANEURYSM USING A POD PACKING COIL (PACKING COIL), A RUBY COIL, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL IN THE TARGET LOCATION USING THE MICROCATHETER. WHILE ADVANCING THE NEXT PACKING COIL TO THE TARGET LOCATION, THE PACKING COIL HAD UNINTENTIONALLY DETACHED PRIOR TO REACHING THE ANEURYSM. THEREFORE, THE PHYSICIAN USED THE PUSHER ASSEMBLY OF THE PACKING COIL TO PUSH THE DETACHED EMBOLIZATION COIL SUCCESSFULLY INTO THE SPLENIC ANEURYSM. THE PROCEDURE WAS COMPLETED USING AN ADDITIONAL 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 24423460 ↗
• MalfunctionDec 18, 2025Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR GLUTEAL ARTERY USING POD PACKING COILS (PACKING COILS), A NON-PENUMBRA COIL, AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS HIGHLY TORTUOUS AND MODERATELY CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE NON-PENUMBRA COIL INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A PACKING COIL IN THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. BOTH THE MICROCATHETER AND THE PACKING COIL WERE THEN REMOVED FROM THE PATIENT AND THE PHYSICIAN FOUND THAT THE MICROCATHETER WAS KINKED. THEREFORE, THE MICROCATHETER WAS NO LONGER USED IN THE PROCEDURE. AFTER INSERTING A SECOND NON-PENUMBRA MICROCATHETER OF THE SAME TYPE INTO THE PATIENT, THE PHYSICIAN ATTEMPTED TO ADVANCE THE SAME PACKING COIL INTO THE MICROCATHETER. WHILE ADVANCING 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 THEN FLUSHED OUT OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING FOUR ADDITIONAL PACKING COILS, SIX NON-PENUMBRA COILS, AND TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840058 ↗
• MalfunctionNov 11, 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 COILS), A RUBY 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 FOUR NON-PENUMBRA COILS, ONE RUBY COIL AND FOUR PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING ANOTHER PACKING COIL THROUGH THE MICROCATHETER, THE PACKING COIL COULD NOT BE ADVANCED AT THE DISTAL END 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. 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 23525909 ↗
• MalfunctionAug 20, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE INTERCOSTAL ARTERY USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE COILS (UNKNOWN) IN THE TARGET LOCATION. WHILE ADVANCING AND POSITIONING A PACKING COIL INTO THE TARGET LOCATION USING THE MICROCATHETER, THE PHYSICIAN NOTICED THE PACKING COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE DETACHED PACKING COIL WAS PARTIALLY INSIDE THE MICROCATHETER AND PARTIALLY IN THE AORTA. THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE DETACHED PACKING COIL. THE PHYSICIAN WAS ADVANCING A NEW PACKING COIL INTO THE VESSEL, BUT THE SAME ISSUE OCCURRED, AND A SNARE DEVICE WAS USED TO REMOVE THE DETACHED PACKING COIL. THE PROCEDURE WAS COMPLETED USING 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 22855580 ↗
• MalfunctionAug 11, 2025Device Damaged Prior to Use; Material Twisted/Bent

  FROM STAFF: DURING EMBOLIZATION WHEN USING COILS-PULLED COIL FROM PACKAGING AND END THAT IS USED TO DETACHED COIL WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769837 ↗
• MalfunctionMay 19, 2025Material Deformation; Premature Separation; Material Deformation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BYPASS GRAFT USING A POD PACKING COIL (PACKING COIL), RUBY COILS, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FOUR RUBY COILS IN THE TARGET VESSEL. WHILE ADVANCING A PACKING COIL IN THE CORONARY GRAFT, THE PACKING COIL UNINTENTIONALLY DETACHED. A BALLOON WAS ADVANCED THROUGH THE GUIDE CATHETER AND INFLATED TO PIN THE DETACHED PACKING COIL AGAINST THE WALL OF THE GUIDE CATHETER. THE GUIDE CATHETER WAS THEN RETRACTED UNDER FLUOROSCOPY WITH THE BALLOON INFLATED AND THE PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE HOSPITAL TECHNICIAN MAY HAVE KINKED THE PACKING COIL PUSHER ASSEMBLY WHILE ADVANCING. AN ANGIOGRAM WAS THEN PERFORMED AND CONFIRMED THAT THE VESSEL WAS SUCCESSFULLY EMBOLIZED. 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 22047085 ↗
• 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 21472183 ↗
• 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 21472180 ↗
• MalfunctionFeb 11, 2025Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PACKING COILS) AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE THIRD PACKING COIL INTO THE TARGET LOCATION, THE PHYSICIAN NOTICED THAT IT WAS NOT PACKING AS DESIRED. THE PACKING COIL WAS RETRACTED IN ORDER TO REPOSITION ONE LOOP OF THE COIL, AND THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE COIL WAS NOT MOVING. SUBSEQUENTLY, THE PHYSICIAN FOUND THAT THE PACKING COIL HAD UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT THE PACKING COIL WAS HALFWAY RETRACTED INTO THE MICROCATHETER AND HALFWAY INSIDE THE PATIENT WHEN IT UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN USED THE PACKING COIL PUSHER WIRE TO PUSH THE REMAINDER OF THE PACKING COIL OUT OF THE MICROCATHETER. HOWEVER, AFTER PUSHING THE PACKING COIL OUT OF THE MICROCATHETER, THE COIL LANDED IN A SUBOPTIMAL LOCATION IN THE TARGET VESSEL. A SNARE DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE PACKING COIL, WITHOUT SUCCESS. THEREFORE, THE PHYSICIAN USED THE SAME MICROCATHETER TO IMPLANT A NON-PENUMBRA COI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21359022 ↗
• MalfunctionJan 17, 2025Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPOGASTRIC ARTERY USING A POD PACKING COIL (PACKING COIL), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A FEW PACKING COILS IN THE TARGET VESSEL. WHILE ADVANCING THE NEXT PACKING COIL THROUGH THE MICROCATHETER, THE PACKING COIL UNINTENTIONALLY DETACHED. THE LANTERN CONTAINING THE DETACHED PACKING 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 21181062 ↗
• MalfunctionOct 22, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PACKING COILS), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS AND NINE PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ADVANCED ANOTHER PACKING COIL INTO THE TARGET VESSEL BUT THE PACKING COIL WOULD NOT TAKE ITS INTENDED SHAPE. THE PHYSICIAN ADVANCED AND RETRACTED THE PACKING COIL SEVERAL TIMES FOR THE PACKING COIL TO TAKE THE INTENDED SHAPE. WHILE RE-ADVANCING THE PACKING COIL, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN THEN PULLED THE PUSHER ASSEMBLY OF THE PACKING COIL BACK AND NOTICED THAT THE PACKING COIL HAD UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING THREE ADDITIONAL PACKING 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 20501646 ↗
• MalfunctionOct 11, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE DISTAL BRANCH OF THE SPLENIC ARTERY USING POD PACKING COILS (PACKING COILS) AND A NON-PENUMBRA MICROCATHETER. IT SHOULD BE NOTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING THE SECOND PACKING COIL TOWARDS THE TARGET VESSEL, THE PACKING COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN INJECTED SALINE THROUGH THE MICROCATHETER AND SUCCESSFULLY IMPLANTED THE PACKING COIL INTO THE TARGET VESSEL. 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 20432415 ↗
• MalfunctionJul 26, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT INTERNAL ILIAC ARTERY USING POD PACKING COILS (PACKING COIL) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED MULTIPLE PACKING COILS IN THE VESSEL USING THE LANTERN. WHILE ADVANCING THE NEXT PACKING COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE PACKING COIL HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN USED A NON-PENUMBRA PUSHER WIRE TO PUSH THE DETACHED PACKING COIL INTO THE TARGET LOCATION AND THE COIL WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS COMPLETED USING NEW PACKING COILS, ADDITIONAL 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 19843837 ↗
• MalfunctionJul 12, 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 POD PACKING COILS (PACKING COIL), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO RUBY COILS AND ONE PACKING COIL INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER PACKING COIL THROUGH THE MID-SHAFT OF THE LANTERN, THE PACKING COIL BECAME STUCK WITHIN THE LANTERN. WHILE ATTEMPTING TO PUSH AND PULL THE PACKING COIL WITHIN THE LANTERN, IT UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PACKING COIL WAS FLUSHED OUT OF THE LANTERN ON THE BACK TABLE. 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 19734278 ↗
• MalfunctionJun 18, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A POD PACKING COIL (PACKING COIL) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PACKING COIL THROUGH ITS INTRODUCER SHEATH, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN CONTINUED TO ADVANCE THE PACKING COIL AGAINST RESISTANCE THROUGH THE MID-SHAFT OF THE MICROCATHETER; HOWEVER, THE RESISTANCE GREW STRONGER. THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL AND WHILE REMOVING, THE PACKING COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PACKING COIL WAS FLUSHED OUT OF THE MICROCATHETER. 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 19559746 ↗
• MalfunctionMay 15, 2024Break; Physical Resistance/Sticking; Premature Separation; Break; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERY TO TREAT PULMONARY ARTERIOVENOUS MALFORMATIONS USING POD PACKING COILS (PACKING COIL), RUBY COILS, A NON-PENUMBRA MICROCATHETER, AND A NON-PENUMBRA CATHETER. IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED THREE RUBY COILS AND FIVE PACKING COILS INTO THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE DISTAL PART OF ANOTHER PACKING COIL PAST THE HUB OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. WHILE CONTINUING TO ADVANCE THE PACKING COIL AGAINST RESISTANCE THROUGH THE PROXIMAL LENGTH OF THE MICROCATHETER, THE PHYSICIAN FRACTURED THE PUSHER ASSEMBLY OF THE PACKING COIL AND THE PACKING COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PACKING COIL WAS REMOVED. 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 19325776 ↗
• MalfunctionMay 15, 2024Material Deformation; Physical Resistance/Sticking; Premature Separation; Material Deformation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IN THE THORACIC AORTIC ARTERY USING POD PACKING COILS (PACKING COILS), RUBY COILS, AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED FIVE RUBY COILS AND TEN PACKING COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ADVANCING ANOTHER PACKING COIL THROUGH THE PROXIMAL LENGTH OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PACKING COIL. WHILE MAKING ANOTHER ATTEMPT TO ADVANCE THE PACKING COIL, RESISTANCE WAS STILL ENCOUNTERED. THE PHYSICIAN THEN KINKED THE PUSHER ASSEMBLY OF THE PACKING COIL AND THE PACKING COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PACKING COIL WAS REMOVED. IT WAS REPORTED THAT THE PACKING 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 19322856 ↗
• InjuryApr 18, 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, THE PHYSICIAN ADVANCED THE PACKING COIL INTO THE TARGET LOCATION USING THE LANTERN; HOWEVER, THE PACKING COIL WAS DETERMINED TO BE TOO LONG. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PACKING COIL. WHILE RETRACTING THE PACKING COIL, THE COIL UNINTENTIONALLY DETACHED INSIDE THE LANTERN AND PARTIALLY IN THE HEPATIC ARTERY. THEREFORE, THE PHYSICIAN USED A STENT TO SECURE THE DETACHED PACKING COIL IN THE HEPATIC ARTERY TO PREVENT THE PACKING COIL FROM MOVING. IT WAS REPORTED THAT THE PHYSICIAN DID NOT INITIALLY ATTEMPT TO REMOVE THE DETACHED PACKING COIL USING A SNARE DEVICE DUE TO THE POTENTIAL DIFFICULTY IT COULD CAUSE AS THE PACKING COIL WAS PARTIALLY WITHIN PREVIOUSLY IMPLANTED COILS. THE PROCEDURE ENDED AT THIS POINT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19131306 ↗
• MalfunctionApr 2, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY (IMA) USING A PACKING COIL (PC) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE PC INTO THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE PC DID NOT FIT IN THE VESSEL. WHILE RETRACTING THE PC THROUGH THE MID-SHAFT OF THE LANTERN, RESISTANCE WAS ENCOUNTERED, AND THE PC UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PC WAS REMOVED. IT WAS REPORTED THAT THE PC WAS FLUSHED OUT OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING A NEW 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 19028271 ↗
• MalfunctionMar 26, 2024Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND PACKING COILS (PC). IT SHOULD BE NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED NON-PENUMBRA COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO ADVANCE A PC INTO THE TARGET VESSEL, THE PHYSICIAN DETERMINED THAT THE PC DID NOT FIT IN THE VESSEL. AFTER SEVERAL STROKES OF RETRACTING THE PC, THE PHYSICIAN NOTICED VIA CONTRAST IMAGING THAT THE COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ANOTHER PC. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983957 ↗
• MalfunctionFeb 10, 2024Physical 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 PACKING COIL (POD PC), A RUBY COIL DETACHMENT HANDLE (HANDLE), A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A GUIDEWIRE. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS SLIGHTLY TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED TWO POD PCS SUCCESSFULLY INTO THE TARGET LOCATION USING THE HANDLE. WHILE ADVANCING ANOTHER POD PC THROUGH THE LANTERN AND INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THAT THE POD PC UNINTENTIONALLY DETACHED HALFWAY OUT OF THE LANTERN. THE POD PC WAS THEN FLUSHED FORWARD AND IMPLANTED INTO THE TARGET VESSEL. THE PROCEDURE WAS COMPLETED USING A RUBY COIL, THE SAME HANDLE, THE SAME LANTERN, AND THE SAME GUIDEWIRE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18682687 ↗
• MalfunctionAug 10, 2023Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation; Physical Resistance/Sticking; Difficult or Delayed Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPRAVODERAL ARTERY USING A POD PACKING COIL (POD PC), A RUBY COIL DETACHMENT HANDLE (HANDLE), AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT''S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED PENUMBRA COILS INTO THE TARGET VESSEL USING THE HANDLE. WHILE ADVANCING THE POD PC HALFWAY THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE. THE PHYSICIAN WAS ABLE TO ADVANCE THE POD PC INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DID NOT LIKE HOW THE POD PC WAS LANDING IN THE TARGET VESSEL AND BEGAN TO RETRACT THE POD PC. WHILE RETRACTING THE POD PC, THE PHYSICIAN NOTICED UNDER FLUOROSCOPY THAT THE POD PC UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. IT WAS REPORTED THAT THE POD PC WAS IMPLANTED INTO ITS TARGET LOCATION. 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 17505180 ↗