POD RBYPODJ30Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI M424RBYPODJ300), received between Apr 20, 2016 and Mar 29, 2022 — classified as 2 injuries, 56 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (19 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RETROPERITONEAL BLEED IN THE INTERNAL HYPOGASTRIC ARTERY USING A POD PACKING COIL (PODJ), A NON-PENUMBRA MICROCATHETER AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A FEW PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE ATTEMPTING TO ADVANCE THE PODJ THROUGH THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND THEREFORE, HE STOPPED ADVANCING THE PODJ. THE PHYSICIAN PULLED BACK ON THE MICROCATHETER REALIZING THAT THE PODJ HAD UNINTENTIONALLY DETACHED WITH MORE THAN HALF OF THE PODJ INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER WAS REMOVED. AFTER REMOVING THE MICROCATHETER, THE PHYSICIAN NOTICED THAT THE COIL WAS IN THE GUIDE CATHETER. THE PHYSICIAN THEN APPLIED NEGATIVE PRESSURE AND REMOVED THE GUIDE CATHETER CONTAINING THE DETACHED PODJ. THE PROCEDURE WAS COMPLETED USING PACKING COIL LPS, RUBY COIL LPS, A NEW NON-PENUMBRA MICROCATHETER AND A NEW GUIDE CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934723 ↗
• MalfunctionDec 20, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A FEEDING ARTERY OF A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING A LANTERN DELIVERY MICROCATHETER (LANTERN), A POD PACKING COIL (PODJ), A NON-PENUMBRA VASCULAR PLUG, A NON-PENUMBRA GUIDING CATHETER, AND A NON-PENUMBRA SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH IN THE PULMONARY ARTERY. THE PHYSICIAN THEN ADVANCED THE VASCULAR PLUG IN THE FEEDING ARTERY USING THE GUIDING CATHETER, LANTERN, AND SHEATH. A CONTRAST OVER THE SHEATH WAS DONE TO CHECK IF THERE WAS STILL FLOW RIGHT AFTER THE FEEDING ARTERY. SINCE, THERE WAS STILL FLOW, THE PHYSICIAN DECIDED TO PULL IN ONE OF THE TWO VASCULAR PLUG CHAMBERS INTO THE GUIDING CATHETER. THE PHYSICIAN THEN ADVANCED THE LANTERN TO THE PARTIALLY RELEASED VASCULAR PLUG AND INSERTED THE PODJ. THE PODJ ADVANCED THROUGH ITS INTRODUCER SHEATH AND INTO THE LANTERN EFFORTLESSLY UNDER CONTINUOUS FLUSH. ONCE THE PODJ ADVANCED OUT OF THE DISTAL END OF THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PODJ IMMEDIATELY FACED THE VASCULAR PLUG. THE PODJ THEN MADE A 180 DEGREE TURN BACK INTO THE FEEDING ARTERY. AT THIS POINT, THE PODJ WAS PUSHED NO MORE THAN APPRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13041499 ↗
• MalfunctionNov 1, 2021Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE 1 ENDOLEAK USING RUBY COILS, A POD PACKING COIL (PODJ), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL TO THE TARGET VESSEL USING THE LANTERN; HOWEVER, THE PHYSICIAN DETERMINED THE RUBY COIL WAS TOO LARGE. THEREFORE, THE RUBY COIL WAS REMOVED INTACT. SUBSEQUENTLY, THE SAME ISSUE OCCURRED WITH ANOTHER RUBY COIL. THEREFORE, THE RUBY COIL WAS ALSO REMOVED INTACT. NEXT, THE PHYSICIAN ADVANCED A PODJ TO THE TARGET VESSEL USING THE LANTERN. WHILE RETRACTING THE PODJ TO REPOSITION IT, THE PODJ UNINTENTIONALLY DETACHED PARTIALLY IN THE ANEURYSM AND PARTIALLY IN THE LANTERN. THEREFORE, THE PHYSICIAN PUSHED THE DETACHED PODJ FROM THE LANTERN INTO THE ANEURYSM USING A GUIDEWIRE. THE PROCEDURE WAS COMPLETED AT THIS POINT AS THE VESSEL WAS COMPLETELY OCCLUDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12731408 ↗
• MalfunctionMar 16, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING POD PACKING COILS (PODJ) AND NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AFTER ADVANCING A PODJ PAST THE HUB OF THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE PODJ AND UPON INSPECTION OUTSIDE OF THE PATIENT, THE PODJ DETACHED FROM THE PUSHER ASSEMBLY. THE PROCEDURE WAS THEN COMPLETED USING A NEW PODJ 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 11499348 ↗
• MalfunctionMar 15, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PODJ) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PODJ IN THE TARGET LOCATION USING THE MICROCATHETER. AFTERWARDS, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO ADVANCE THE NEXT PODJ WITHIN ITS INTRODUCER SHEATH. SUBSEQUENTLY, THE PODJ WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A RUBY COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11489823 ↗
• MalfunctionNov 25, 2020Unintended Movement; Unintended Movement

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING POD PACKING COILS (PODJS), RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. THEN, THE PHYSICIAN PLACED A PODJ (F94195) INTO THE TARGET LOCATION USING THE LANTERN AND WHEN CHECKING THE DENSITY VIA AN ANGIOGRAPHY, EVERYTHING WAS GREAT. THREE MINUTES LATER, WHILE SUCCESSFULLY PLACING ANOTHER RUBY COIL INTO THE VEIN, IT WAS SEEN VIA AN ANGIOGRAPHY THAT THE PREVIOUS PODJ THAT WAS PLACED WAS GETTING A BIT LOOSE MAKING A SMALL LOOP PROXIMAL. SUBSEQUENTLY, A FEW MINUTES LATER, THE PROXIMAL END OF THE PODJ LOOSENED MORE. THE PHYSICIAN THEN PLACED ANOTHER RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. THEN, WHILE ADVANCING ANOTHER PODJ (F97197), THE PODJ UNINTENTIONALLY DETACHED AND SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO MANIPULATE THE PODJ TO REACH THE TARGET LOCATION. THEREFORE, THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY AND ATTEMPTED TO PUSH THE PODJ USING A NON-PENUMBRA GUIDEWIRE INTO THE TARGET LOCATION WITH LIMITED SUCCESS. IT WAS REPORTED THAT THE PROXI

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

  MAUDE report 10906717 ↗
• MalfunctionNov 25, 2020Migration; Premature Separation; Migration; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM) USING POD PACKING COILS (PODJS), RUBY COILS AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED A RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. THEN, THE PHYSICIAN PLACED A PODJ (F94195) INTO THE TARGET LOCATION USING THE LANTERN AND WHEN CHECKING THE DENSITY VIA AN ANGIOGRAPHY, EVERYTHING WAS GREAT. THREE MINUTES LATER, WHILE SUCCESSFULLY PLACING ANOTHER RUBY COIL INTO THE VEIN, IT WAS SEEN VIA AN ANGIOGRAPHY THAT THE PREVIOUS PODJ THAT WAS PLACED WAS GETTING A BIT LOOSE MAKING A SMALL LOOP PROXIMAL. SUBSEQUENTLY, A FEW MINUTES LATER, THE PROXIMAL END OF THE PODJ LOOSENED MORE. THE PHYSICIAN THEN PLACED ANOTHER RUBY COIL INTO THE TARGET LOCATION USING THE LANTERN. THEN, WHILE ADVANCING ANOTHER PODJ (F97197), THE PODJ UNINTENTIONALLY DETACHED AND SUBSEQUENTLY, THE PHYSICIAN WAS UNABLE TO MANIPULATE THE PODJ TO REACH THE TARGET LOCATION. THEREFORE, THE PHYSICIAN REMOVED THE PUSHER ASSEMBLY AND ATTEMPTED TO PUSH THE PODJ USING A NON-PENUMBRA GUIDEWIRE INTO THE TARGET LOCATION WITH LIMITED SUCCESS. IT WAS REPORTED THAT THE PROXI

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

  MAUDE report 10906704 ↗
• MalfunctionAug 22, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT SUBCLAVIAN ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN), POD PACKING COILS (POD PCS), RUBY COILS, AND A CATHETER. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN. THE PHYSICIAN THEN ATTEMPTED TO IMPLANT A POD PC, BUT THE POD PC DID NOT FIT IN THE VESSEL. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO REMOVE THE POD PC. WHILE RETRACTING THE POD PC AND THE LANTERN THROUGH CATHETER, THE LANTERN BROKE AT THE MID-SHAFT. IT WAS REPORTED THAT WHILE REMOVING THE POD PC THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE POD PC AND LANTERN WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING A NON-PENUMBRA CATHETER, NON-PENUMBRA COIL, AND THE SAME CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440510 ↗
• InjuryMar 6, 2020Physical 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 (PODJS) AND A MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED THE FIRST PODJ IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING THE SECOND PODJ INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. IT WAS REPORTED THAT THE PODJ WAS TOO LONG AND AFTER SEVERAL ATTEMPTS TO ADVANCE THE PODJ INTO THE TARGET VESSEL, THE PHYSICIAN DECIDED TO REMOVE IT. HOWEVER, UPON RETRACTION, THE PODJ UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE REMOVE THE DETACHED PODJ, CAUSING INCREASED RADIATION EXPOSURE. THE PROCEDURE WAS COMPLETED USING A SMALLER COIL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9800469 ↗
• MalfunctionFeb 27, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COIL (PODJ) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PODJ THROUGH THE MICROCATHETER, THE PODJ BECAME STUCK INSIDE THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9766516 ↗
• MalfunctionNov 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS) AND A RUBY COIL. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN PLACED A POD6 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. NEXT, THE PHYSICIAN ATTEMPTED TO ADVANCE A PODJ (F84471); HOWEVER, THE COIL WOULD NOT ADVANCE THROUGH THE MICROCATHETER; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE TWO NEW PODJS (F84743 AND F91605) AND A RUBY COIL (F80309); HOWEVER, THE SAME ISSUE OCCURRED, AND THE COILS WOULD NOT ADVANCE THROUGH THE MICROCATHETER. THEREFORE, THE PODJS AND RUBY COIL WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NON-PENUMBRA EMBOLIC AGENT IN ORDER TO NOT LOSE ACCESS TO THE TORTUOUS VESSEL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328597 ↗
• MalfunctionJul 26, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT TRANSFEMORAL ARTERY USING A RUBY COIL AND A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ADVANCE A RUBY COIL THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, AFTER ADVANCING APPROXIMATELY 20 CM INTO THE LANTERN, THE RUBY COIL REMAINED STUCK BEFORE REACHING THE DISTAL END OF THE LANTERN. THEREFORE, THE RUBY COIL WAS REMOVED AND A NEW RUBY COIL WAS SUCCESSFULLY IMPLANTED. THE PHYSICIAN THEN ATTEMPTED TO PLACE A PODJ; HOWEVER, RESISTANCE WAS EXPERIENCED AND THE PODJ UNINTENTIONALLY DETACHED WITHIN THE LANTERN WHILE BEING RETRACTED. THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED USING A NEW PODJ AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8832348 ↗
• MalfunctionJul 2, 2019Physical 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 (POD PCS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL, TWO POD PCS, AND A NON-PENUMBRA COIL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). DESPITE REACHING 40% PACKING DENSITY, THE PHYSICIAN ATTEMPTED TO PLACE ANOTHER POD PC, HOWEVER, THE PHYSICIAN FELT SLIGHT RESISTANCE WHILE ADVANCING THE POD PC INTO THE TARGET LOCATION. THEREFORE, THE PHYSICIAN ATTEMPTED TO REMOVE THE POD PC, HOWEVER, THE COIL UNINTENTIONALLY DETACHED WHILE BEING RETRACTED. THE PHYSICIAN USED A SYRINGE TO CREATE SUCTION WITHIN THE LANTERN, AND THEN RETRACTED AND REMOVED THE LANTERN. THE DETACHED COIL WAS RETRACTED WITH THE LANTERN TO THE HUB OF THE SHEATH, AND THE PHYSICIAN WAS THEN ABLE TO REMOVE IT. THE PROCEDURE ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8753845 ↗
• MalfunctionMay 15, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, A PODJ WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE PODJ OUT OF ITS INTRODUCER SHEATH AND INTO A BOWL OF SALINE BUT IT WOULD NOT ADVANCE. THE PROCEDURE WAS THEREFORE COMPLETED USING A NEW PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612076 ↗
• MalfunctionMay 2, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PODJ, THE PHYSICIAN NOTICED IT BECAME LOOSE AND UNINTENTIONALLY DETACHED IN THE VEIN. SUBSEQUENTLY, THE PHYSICIAN PLACED ANOTHER COIL BEHIND THE DETACHED PODJ USING THE SAME MICROCATHETER AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8574476 ↗
• MalfunctionFeb 7, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN GAINED ACCESS THROUGH THE PATIENT¿S RIGHT FEMORAL ARTERY. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A RUBY COIL OUT OF THE TIP OF A LANTERN DELIVERY MICROCATHETER (LANTERN) AND, THEREFORE, THE PHYSICIAN RETRACTED THE COIL. WHILE RETRACTING, THE PHYSICIAN FELT RESISTANCE AND THE RUBY COIL UNINTENTIONALLY DETACHED. THE PHYSICIAN ATTEMPTED TO PLACE THE RUBY COIL BY ADVANCING IT WITH THE PUSHER ASSEMBLY BUT WAS UNABLE TO. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE MICROCATHETER WITH THE RUBY COIL INSIDE, HOWEVER ONLY THE NITINOL WIRE CAME OUT WITH THE LANTERN. THE PHYSICIAN THEN USED A SNARE DEVICE TO REMOVE THE REST OF THE RUBY COIL. IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THAT THE RUBY COIL MIGHT HAVE BEEN TOO LARGE FOR THE TARGET LOCATION, CAUSING RESISTANCE. THE PHYSICIAN THEN PUNCTURED THE LEFT FEMORAL ARTERY AND SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET LOCATION USING THE SAME LANTERN. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PODJ OUT OF THE TIP OF THE LANTERN AND, THEREFORE, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319133 ↗
• MalfunctionJan 18, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PODJ BECAME STUCK AT THE DISTAL END OF A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE THE PODJ FROM THE MICROCATHETER. THE PROCEDURE WAS THEN COMPLETED USING NEW COILS AND THE SAME MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262444 ↗
• MalfunctionDec 21, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERALS BETWEEN THE AORTA AND PULMONAL ARTERY USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST 30CM PODJ THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE PODJ WOULD NOT ADVANCE MORE THAN 20CM OUT OF THE LANTERN. THE PODJ WAS THEREFORE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A 15CM PODJ; HOWEVER, WHILE ATTEMPTING TO ADVANCE ANOTHER 30CM PODJ, USING THE SAME LANTERN, THE SAME RESISTANCE WAS EXPERIENCED AS WITH THE FIRST PODJ. THIS PODJ WAS, THEREFORE, ALSO REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER 15CM PODJ AND TWO RUBY COILS USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, IT WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. AFTER MAKING FURTHER ATTEMPTS TO PUSH THE RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE RUBY COIL WAS STILL UNABLE TO EXIT THE SHEATH AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189284 ↗
• MalfunctionDec 21, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE COLLATERALS BETWEEN THE AORTA AND PULMONAL ARTERY USING POD PACKING COILS (PODJS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING THE FIRST 30CM PODJ THROUGH THE LANTERN DELIVERY MICROCATHETER (LANTERN) INTO THE TARGET VESSEL. IT WAS REPORTED THAT THE PODJ WOULD NOT ADVANCE MORE THAN 20CM OUT OF THE LANTERN. THE PODJ WAS THEREFORE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED A 15CM PODJ; HOWEVER, WHILE ATTEMPTING TO ADVANCE ANOTHER 30CM PODJ, USING THE SAME LANTERN, THE SAME RESISTANCE WAS EXPERIENCED AS WITH THE FIRST PODJ. THIS PODJ WAS, THEREFORE, ALSO REMOVED. THE PHYSICIAN THEN SUCCESSFULLY PLACED ANOTHER 15CM PODJ AND TWO RUBY COILS USING THE SAME LANTERN. WHILE ATTEMPTING TO ADVANCE ANOTHER RUBY COIL, IT WOULD NOT ADVANCE OUT OF ITS INTRODUCER SHEATH. AFTER MAKING FURTHER ATTEMPTS TO PUSH THE RUBY COIL THROUGH ITS INTRODUCER SHEATH, THE RUBY COIL WAS STILL UNABLE TO EXIT THE SHEATH AND WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8189282 ↗
• MalfunctionNov 22, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE NON-PENUMBRA COILS AND A PODJ BY ADVANCING WITHIN A DIAGNOSTIC CATHETER WITHOUT A MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE ANOTHER PODJ, HOWEVER, THE PODJ TOOK ITS SHAPE WITHIN THE DIAGNOSTIC CATHETER. THEREFORE, THE PHYSICIAN REMOVED THE CATHETER WITH THE PODJ INSIDE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS AND THE SAME DIAGNOSTIC CATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098170 ↗
• MalfunctionNov 15, 2018Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED IN THE GASTRODUODENAL ARTERY (GDA) USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A PODJ INTO THE GDA, THE LANTERN BEGAN TO KICK BACK. THE PHYSICIAN THEN EXPERIENCED RESISTANCE WHILE ATTEMPTING TO REPOSITION THE PODJ AND SUBSEQUENTLY, THE PODJ UNWOUND. AT THAT POINT, THE PHYSICIAN HAD ALREADY ADVANCED APPROXIMATELY TWO THIRDS OF THE PODJ INTO THE GDA. THE PHYSICIAN THEN CUT THE PODJ INTRODUCER SHEATH USING A SCISSOR AND FLUSHED THE REMAINING PODJ INTO THE GDA. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND THE SAME LANTERN TO LOCK IN THE PODJ WITHIN THE GDA. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8076096 ↗
• MalfunctionOct 15, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS USING A NON-PENUMBRA MICROCATHETER. THEN, THE PHYSICIAN FELT RESISTANCE ADVANCING A RUBY COIL AND THREE PODJS THROUGH EXTREMELY TORTUOUS ANATOMY; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE USING RUBY COILS, NON-PENUMBRA COILS, EMBOLIZATION PLUGS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY, AND THE PHYSICIAN DID NOT US AN RHV OR MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7964065 ↗
• MalfunctionOct 15, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE COILS USING A NON-PENUMBRA MICROCATHETER. THEN, THE PHYSICIAN FELT RESISTANCE ADVANCING A RUBY COIL AND THREE PODJS THROUGH EXTREMELY TORTUOUS ANATOMY; THEREFORE, THEY WERE REMOVED. THE PHYSICIAN COMPLETED THE PROCEDURE USING RUBY COILS, NON-PENUMBRA COILS, EMBOLIZATION PLUGS, AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PATIENT HAD TORTUOUS ANATOMY, AND THE PHYSICIAN DID NOT US AN RHV OR MAINTAIN CONTINUOUS FLUSH. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7964061 ↗
• MalfunctionSep 21, 2018Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY TO TREAT A GASTROINTESTINAL BLEEDING (GI BLEED) USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE HOSPITAL STAFF UNINTENTIONALLY KINKED THE PUSHER ASSEMBLY OF THE PODJ WHILE ATTEMPTING TO LOAD INTO A LANTERN DELIVERY MICROCATHETER (LANTERN AND, THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PODJ WITH THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7898965 ↗
• MalfunctionJul 5, 2018Detachment Of Device Component; Mechanical Jam; Device Handling Problem; Detachment Of Device Component; Mechanical Jam; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HEPATIC ARTERY USING POD PACKING COILS (PODJ¿S) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A PODJ THROUGH A LANTERN, THE PODJ GOT STUCK INSIDE THE LANTERN AT THE POINT WHERE THE LANTERN WAS EXITING THE GUIDE CATHETER. THEREFORE, THE PODJ WAS PULLED BACK AND PARTIALLY RE-SHEATHED. HOWEVER, UPON REMOVAL FROM THE ROTATING HEMOSTASIS VALVE (RHV), THE PODJ BECAME DETACHED. IT APPEARED THAT THERE WAS SOME EXCESSIVE MANIPULATION ON THE PODJ. THE PHYSICIAN THEN MADE A SECOND ATTEMPT TO DELIVER ANOTHER PODJ; HOWEVER, THE PODJ BECAME STUCK AT THE SAME POSITION IN THE LANTERN; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. UPON RETRACTION, THE PODJ UNINTENTIONALLY DETACHED INSIDE THE LANTERN AND BECAME STUCK. THE PHYSICIAN ATTEMPTED TO PUSH THE DETACHED PODJ, BUT WAS UNABLE TO PUSH IT FORWARD USING THE PUSHER ASSEMBLY OR FLUSH IT FORWARD. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED FROM THE PATIENT. UPON REMOVAL, IT WAS NOTICED THAT THE LANTERN WAS KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND TWO RUBY COILS. THERE WAS NO REPORT OF AN ADVERS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7664553 ↗