POD RBYPODJ60Recalls & reported problems

Summary

The FDA's MAUDE database contains 131 adverse event reports that list this exact device (DI M424RBYPODJ600), received between Mar 21, 2016 and Jan 11, 2022 — classified as 9 injuries, 122 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (58 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 131 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PELVIC CONGESTION SYNDROME USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, POD PACKING COILS (PODJ), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN, THEN USED THE HANDLE TO DETACH IT. HOWEVER, AFTER SUCCESSFUL DETACHMENT OF THE RUBY COIL, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THE PHYSICIAN THEN USED A NEW HANDLE TO SUCCESSFULLY IMPLANT THE NEXT RUBY COILS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A PODJ IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO PULL ONE LOOP OF THE PODJ BACK TO REPOSITION IT, THE PODJ UNINTENTIONALLY DETACHED, WITH PART OF THE PODJ INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY OR DAMAGE TO THE LANTERN AFTER REMOVAL. A NEW LANTERN WAS THEN INSERTED INTO THE PATIENT AND THE PHYSICIAN ADVANCED A NEW PODJ IN THE TARGET VESSEL USING THE LANTERN. HOWEVER, WHILE ATTEMPTING TO REPOSITION THE PODJ, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227800 ↗
• MalfunctionJan 11, 2022Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT PELVIC CONGESTION SYNDROME USING A RUBY COIL DETACHMENT HANDLE (HANDLE), RUBY COILS, POD PACKING COILS (PODJ), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A RUBY COIL IN THE TARGET VESSEL USING THE LANTERN, THEN USED THE HANDLE TO DETACH IT. HOWEVER, AFTER SUCCESSFUL DETACHMENT OF THE RUBY COIL, THE PUSHER ASSEMBLY OF THE RUBY COIL BECAME STUCK IN THE HANDLE. THE PHYSICIAN THEN USED A NEW HANDLE TO SUCCESSFULLY IMPLANT THE NEXT RUBY COILS IN THE TARGET VESSEL. NEXT, THE PHYSICIAN ADVANCED A PODJ IN THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO PULL ONE LOOP OF THE PODJ BACK TO REPOSITION IT, THE PODJ UNINTENTIONALLY DETACHED, WITH PART OF THE PODJ INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED. IT SHOULD BE NOTED THAT THERE WAS NO ALLEGED DEVICE DEFICIENCY OR DAMAGE TO THE LANTERN AFTER REMOVAL. A NEW LANTERN WAS THEN INSERTED INTO THE PATIENT AND THE PHYSICIAN ADVANCED A NEW PODJ IN THE TARGET VESSEL USING THE LANTERN. HOWEVER, WHILE ATTEMPTING TO REPOSITION THE PODJ, IT UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13227773 ↗
• MalfunctionNov 9, 2021Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING POD PACKING COILS (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING THE PODJ INTO THE LANTERN, THE PODJ BECAME STUCK APPROXIMATELY ONE THIRD OF THE WAY INTO THE LANTERN. THEREFORE, THE PODJ WAS REMOVED. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12780694 ↗
• MalfunctionOct 1, 2021Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, WHILE ATTEMPTING TO IMPLANT THE PODJ INTO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE. THEREFORE, THE PODJ WAS RE-SHEATHED AND THE LANTERN WAS FLUSHED. WHILE ATTEMPTING TO RE-ADVANCE THE PODJ, THE COIL WOULD NOT ADVANCE FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND THE SAME LANTERN. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565678 ↗
• MalfunctionJun 7, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, A PODJ WOULD NOT ADVANCE FROM THE STARTING POSITION OF THE INTRODUCER SHEATH. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11953148 ↗
• InjuryMar 16, 2021Migration; Migration

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY ARTERIOVENOUS MALFORMATION (AVM) USING A POD PACKING COIL (PODJ) AND A NON-PENUMBRA CATHETER (PROGREAT). DURING THE PROCEDURE, THE PHYSICIAN PLACED A PODJ IN THE TARGET VESSEL USING THE MICROCATHETER. AFTER PLACING ANOTHER PODJ IN THE VESSEL, THE PODJ PROLAPSED INTO THE MAIN PULMONARY ARTERY. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE IN AN ATTEMPT TO REMOVE THE PODJ. WHILE SNARING THE PODJ, THE COIL BECAME FRACTURED AND HAD UNRAVELED. IT WAS REPORTED THAT THE PHYSICIAN PULLED THE REMAINING COIL FILAMENT IN SEVERAL PIECES AND REMOVED THE PODJ. THE PROCEDURE HAD ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11498362 ↗
• MalfunctionMar 8, 2021Physical Resistance/Sticking; 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 EXPERIENCED RESISTANCE WHEN ADVANCING A PODJ INTO THE TARGET VESSEL USING THE MICROCATHETER. THEREFORE, THE PODJ WAS RETRACTED AND RE-SOAKED IN SALINE. SUBSEQUENTLY, THE PHYSICIAN REPOSITIONED THE MICROCATHETER, AND ATTEMPTED TO ADVANCE THE SAME PODJ INTO THE VESSEL; HOWEVER, THE SAME THE ISSUE OCCURRED. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS 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 11434736 ↗
• MalfunctionMar 3, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY TO TREAT A LEAK ON THE PREVIOUSLY PLACED AMPLATZER PLUG USING POD PACKING COILS (PODJS), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PODJ ON TOP OF THE AMPLATZER PLUG USING THE LANTERN. THE PHYSICIAN THEN PLACED ANOTHER PODJ IN THE TARGET LOCATION AND DECIDED TO RETRACT THE PODJ TO REPOSITION. WHILE RETRACTING THE PODJ, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PODJ UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE PHYSICIAN THEN REMOVED THE LANTERN CONTAINING THE DETACHED PODJ AND NOTICED THAT PART OF THE PODJ WAS IN THE VESSEL AND THE OTHER PART OF THE PODJ WAS IN THE DIAGNOSTIC CATHETER. UPON REMOVAL OF THE DIAGNOSTIC CATHETER, THE PHYSICIAN NOTICED THAT PART OF THE PODJ WAS IN THE VESSEL AND THE OTHER PART OF THE PODJ WAS IN THE SHEATH. SUBSEQUENTLY, THE PODJ BROKE INTO TWO PIECES; THEREFORE, THE PHYSICIAN PULLED THE BROKEN PODJ FROM THE SHEATH. THE PHYSICIAN THEN PLACED ADDITIONAL PODJS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER PODJ THROUGH THE LANTERN, THE PODJ BECAME STUCK AT

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

  MAUDE report 11404765 ↗
• MalfunctionMar 3, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUBCLAVIAN ARTERY TO TREAT A LEAK ON THE PREVIOUSLY PLACED AMPLATZER PLUG USING POD PACKING COILS (PODJS), A LANTERN DELIVERY MICROCATHETER (LANTERN), A NON-PENUMBRA DIAGNOSTIC CATHETER AND A SHEATH. DURING THE PROCEDURE, THE PHYSICIAN PLACED A PODJ ON TOP OF THE AMPLATZER PLUG USING THE LANTERN. THE PHYSICIAN THEN PLACED ANOTHER PODJ IN THE TARGET LOCATION AND DECIDED TO RETRACT THE PODJ TO REPOSITION. WHILE RETRACTING THE PODJ, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE PODJ UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE PHYSICIAN THEN REMOVED THE LANTERN CONTAINING THE DETACHED PODJ AND NOTICED THAT PART OF THE PODJ WAS IN THE VESSEL AND THE OTHER PART OF THE PODJ WAS IN THE DIAGNOSTIC CATHETER. UPON REMOVAL OF THE DIAGNOSTIC CATHETER, THE PHYSICIAN NOTICED THAT PART OF THE PODJ WAS IN THE VESSEL AND THE OTHER PART OF THE PODJ WAS IN THE SHEATH. SUBSEQUENTLY, THE PODJ BROKE INTO TWO PIECES; THEREFORE, THE PHYSICIAN PULLED THE BROKEN PODJ FROM THE SHEATH. THE PHYSICIAN THEN PLACED ADDITIONAL PODJS IN THE TARGET LOCATION USING THE LANTERN. WHILE ADVANCING ANOTHER PODJ THROUGH THE LANTERN, THE PODJ BECAME STUCK AT

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

  MAUDE report 11404757 ↗
• MalfunctionMar 2, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE FOR A RENAL ARTERY ANEURYSM USING A POD PACKING COIL (PODJ) AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCE RESISTANCE WHEN ADVANCING A PODJ INTO THE PX SLIM. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW PODJ AND THE SAME PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 11401228 ↗
• MalfunctionSep 30, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING RUBY COILS, POD PACKING COILS (PODJS), AND LANTERN DELIVERY MICROCATHETERS (LANTERN). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL THROUGH A LANTERN, THE RUBY COIL UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED RUBY COIL WAS REMOVED, AND THE RUBY COIL WAS FLUSHED OUT. THE LANTERN WAS NOTED TO BE KINKED AND THEREFORE, WAS NOT USED FOR THE REMAINDER OF THE PROCEDURE. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND IMPLANTED ANOTHER RUBY COIL USING A NEW LANTERN. SUBSEQUENTLY, WHILE ADVANCING A PODJ THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE PODJ UNINTENTIONALLY DETACHED. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED, AND THE PODJ WAS TAKEN OUT. IT WAS REPORTED THAT THE DETACHED PODJ WAS OBSERVED TO BE HANGING BY THE UNDERLYING NYLON UPON REMOVAL OF THE LANTERN. THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ AND THE SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10609959 ↗
• MalfunctionSep 21, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING A LANTERN DELIVERY MICROCATHETERS (LANTERN) AND POD PACKING COILS (PODJ). DURING THE PROCEDURE, WHILE ATTEMPTING TO ROTATE THE LANTERN FROM THE LEFT RENAL VEIN INTO THE LEFT OVARIAN VEIN, THE LANTERN BROKE APPROXIMATELY FIFTEEN CENTIMETERS FROM THE PROXIMAL HUB OUTSIDE THE PATIENT''S BODY. THEREFORE, THE LANTERN WAS PULLED OUT. THE PHYSICIAN THEN PLACED THREE RUBY COILS AND TWO PODJS INTO THE TARGET VESSEL USING A NEW LANTERN. NEXT, THE PHYSICIAN ADVANCED ANOTHER PODJ INTO THE TARGET VESSEL AND DETERMINED THAT IT WAS TOO LONG; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PODJ. WHILE RETRACTING THE PODJ, IT BECAME STUCK AT THE DISTAL END OF THE LANTERN AND SUBSEQUENTLY, UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED AND THE PODJ WAS FLUSHED OUT. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10560528 ↗
• MalfunctionSep 16, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (PODJS), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THREE RUBY COILS AND A PODJ SEPARATELY THROUGH THE PROXIMAL END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE, AND THE RUBY COILS AND PODJ BECAME STUCK. THEREFORE, THE RUBY COILS AND PODJ WERE REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER RUBY COILS. IT IS UNKNOWN IF THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

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

  MAUDE report 10544013 ↗
• MalfunctionAug 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT GONADAL VEIN USING POD PACKING COILS (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PODJ PARTIALLY THROUGH ITS INTRODUCER SHEATH AND THE PODJ BECAME STUCK; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW A PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405230 ↗
• MalfunctionJul 17, 2020Break; Material Deformation; Break; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE AORTA USING RUBY COILS, POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT THE NEXT COIL, A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THE PHYSICIAN THEN PLACED TWO RUBY COILS INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A PODJ INTO THE LANTERN, THE SAME ISSUE OCCURRED. THE PUSHER ASSEMBLY OF THE PODJ KINKED AND SUBSEQUENTLY, THE PODJ DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN PLACED ONE PODJ INTO THE TARGET VESSEL USING THE LANTERN. WHILE ATTEMPTING TO INSERT A RUBY COIL INTO THE LANTERN, THE PUSHER ASSEMBLY OF THE RUBY COIL KINKED. SUBSEQUENTLY, THE RUBY COIL DETACHED WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE RUBY COIL WAS REMOVED. THEN, THE PHYSICIAN ATTEMPTED TO INSERT A PODJ INTO THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED; THEREFORE, THE PODJ WAS REMOVED. THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10290760 ↗
• MalfunctionJul 10, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS), A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING THE HANDLE. THE PHYSICIAN THEN ADVANCED A PODJ INTO THE VESSEL AND USED THE HANDLE TO DETACH IT; HOWEVER, THE PODJ FAILED TO DETACH. THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PODJS, THE SAME HANDLE AND LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10261350 ↗
• MalfunctionJun 19, 2020Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL JUGULAR VEIN USING RUBY COILS, POD PACKING COILS (PODJ) AND A PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, WHILE ADVANCING A RUBY COIL (C16974) INTO THE TARGET VESSEL USING THE PX SLIM, THE PHYSICIAN EXPERIENCED RESISTANCE DURING ADVANCING THE LAST THREE CENTIMETERS OF THE COIL AND, THEREFORE, THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL THROUGH THE PX SLIM, THE COIL BECAME UNRAVELED. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE UNRAVELED RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO REMOVE IT. NEXT, THE PHYSICIAN ADVANCED A NEW RUBY COIL (F91740) THROUGH THE PX SLIM; HOWEVER, RESISTANCE WAS ENCOUNTERED AGAIN WHILE ADVANCING THE LAST THREE CENTIMETERS OF THE RUBY COIL. THE PHYSICIAN DECIDED TO RE-SHEATH AND REDEPLOY THE RUBY COIL. HOWEVER, WHILE ADVANCING THE RUBY COIL, THE SAME ISSUE OCCURRED, AND THE RUBY COIL BECAME UNRAVELED. IT WAS ALSO REPORTED THAT THE RUBY COIL WAS CUT FROM THE END AS IT WAS STUCK INSIDE THE PX SLIM. THE PHYSICIAN THEN REMOVED THE PX SLIM CONTAINING THE REMAINING RUBY COIL AND SAFELY FLUSHED OUT THE COIL TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176887 ↗
• MalfunctionApr 24, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED TWO PENUMBRA COILS IN THE TARGET VESSEL USING THE MICROCATHETER. THEN, THE PHYSICIAN ATTEMPTED TO ADVANCE A PODJ OUT OF ITS INTRODUCER SHEATH AND INTO THE MICROCATHETER; HOWEVER, THE PODJ WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING FOUR PENUMBRA COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996964 ↗
• MalfunctionMar 20, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PODJ INTO THE TARGET VESSEL USING THE LANTERN AND NEEDED TO REPOSITION THE PODJ. WHILE REPOSITIONING THE PODJ, IT UNINTENTIONALLY DETACHED INSIDE THE LANTERN; THEREFORE, THE LANTERN CONTAINING THE DETACHED PODJ WAS REMOVED AND THE PODJ WAS FLUSHED OUT. 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 9861820 ↗
• MalfunctionMar 12, 2020Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD, RUBY COILS, A POD PACKING COIL (POD PC) AND A NON-PENUMBRA MICROCATHETER. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED A POD COIL IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE ADVANCING A RUBY COIL THROUGH THE MICROCATHETER, THE RUBY COIL UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED RUBY COIL WAS REMOVED AND THE RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN THEN IMPLANTED A NEW RUBY COIL IN THE TARGET VESSEL USING THE MICROCATHETER. NEXT, WHILE INSERTING A POD PC INTO THE HUB OF THE MICROCATHETER, THE POD PC UNINTENTIONALLY DETACHED IN THE HUB OF THE MICROCATHETER; THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD PC WAS REMOVED AND THE POD PC WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING TWO NON-PENUMBRA 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 9825896 ↗
• MalfunctionJan 28, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PANCREATICODUODENAL ARTERY USING POD PACKING COILS (PODJS) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY IMPLANTED TWO PODJS IN THE TARGET VESSEL USING THE MICROCATHETER. WHILE FILLING UP ANEURYSM SAC WITH ANOTHER PODJ, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PODJ. WHILE RE-SHEATHING THE PODJ, THE PHYSICIAN REALIZED THAT THE PODJ HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER; THEREFORE, THE PHYSICIAN PULLED THE PODJ FROM THE MICROCATHETER AND REMOVED THE SHEATH ALONG WITH THE DETACHED PODJ. THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ 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 9638015 ↗
• MalfunctionJan 8, 2020Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS FISTULA (AVF) USING POD PACKING COILS (PODJ) AND TWO PX SLIM DELIVERY MICROCATHETERS (PX SLIMS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED TWO PX SLIMS TO THE TARGET VESSEL FROM TWO DIFFERENT ACCESS POINTS. WHILE ADVANCING THE PODJ THROUGH ONE OF THE PX SLIMS, THE PHYSICIAN EXPERIENCED RESISTANCE APPROXIMATELY TEN CENTIMETERS INTO THE PX SLIM; THEREFORE, THE PODJ WAS REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCED THE PODJ INTO THE OTHER PX SLIM; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PODJS AND BOTH PX SLIMS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566764 ↗
• MalfunctionDec 18, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE THIRD PODJ INTO A NON-PENUMBRA MICROCATHETER, THE PODJ STARTED TAKING SHAPE INSIDE THE ROTATING HEMOSTASIS VALVE (RHV) THAT WAS ATTACHED TO THE MICROCATHETER. THEREFORE, THE PHYSICIAN DECIDED TO RETRACT THE PODJ INTO ITS INTRODUCER SHEATH IN ORDER TO REPOSITION IT AND EXPERIENCED RESISTANCE WHILE RETRACTING. DURING RETRACTION, RESISTANCE WAS ENCOUNTER AND SUBSEQUENTLY, THE PODJ DETACHED FROM ITS PUSHER ASSEMBLY INSIDE THE RVH; THEREFORE, THE PODJ WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER RUBY COIL 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 9486097 ↗
• MalfunctionNov 22, 2019Material Deformation; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING RUBY COILS, POD PACKING COILS (POD PCS) AND A RUBY COIL DETACHMENT HANDLE (HANDLE). DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING A RUBY COIL THROUGH THE NON-PENUMBRA MICROCATHETER. SUBSEQUENTLY, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED FROM THE PATIENT AND THE DETACHED RUBY COIL WAS FLUSHED OUT. THE PHYSICIAN CONTINUED THE PROCEDURE BY RE-ADVANCING THE SAME MICROCATHETER AND ANOTHER RUBY COIL INTO THE TARGET VESSEL. WHILE ATTEMPTING TO DETACH THE RUBY COIL USING THE HANDLE, THE PHYSICIAN REALIZED THAT THE PROXIMAL END OF THE PUSHER ASSEMBLY WAS STUCK IN THE HANDLE. HOWEVER, THE PHYSICIAN WAS ABLE TO DETACH AND IMPLANT THE RUBY COIL INTO THE TARGET VESSEL AFTER CLICKING THE HANDLE APPROXIMATELY 2-3 TIMES. IT WAS REPORTED THAT THE PUSHER ASSEMBLY REMAINED STUCK IN THE HANDLE; THEREFORE, THE HANDLE WAS REMOVED FROM THE PROCEDURE. UPON ADVANCING THE NEXT POD PC INTO THE MICROCATHETER, THE PUSHER WIRE BECAME KINKED. THEREFORE, THE POD PC WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW HANDLE AND ANOTHER RUBY CO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9365692 ↗
• 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 9328589 ↗