POD RBYPODJ45Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI M424RBYPODJ450), received between Feb 18, 2016 and Apr 9, 2022 — classified as 4 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (21 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE CELIAC TRUNK AND SPLENIC ARTERY USING A POD PACKING COIL (PODJ), A LANTERN DELIVERY MICROCATHETER (LANTERN) AND A NON-PENUMBRA GUIDE CATHETER. DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY TWENTY-FIVE PERCENT OF THE PODJ INTO THE ANEURYSM USING THE LANTERN AND GUIDE CATHETER, THE PHYSICIAN DECIDED TO RETRACT THE PODJ. WHILE RETRACTING THE PODJ, THE PHYSICIAN EXPERIENCED RESISTANCE AND SUBSEQUENTLY, THE PODJ UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN REMOVED THE GUIDE CATHETER WITH THE LANTERN THAT CONTAINED THE DETACHED PODJ AND THEN FLUSHED THE PODJ OUT OF THE LANTERN. 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 14069062 ↗
• MalfunctionMar 1, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD PACKING COIL (PODJ) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING THE PODJ ALMOST THROUGH THE END OF THE MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PODJ. WHILE RETRACTING THE PODJ, THE PODJ UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PENUMBRA 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 13644576 ↗
• MalfunctionJun 11, 2021Difficult to Advance; Difficult to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT AN AORTIC ANEURYSM USING A POD PACKING COIL (PODJ) AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY ADVANCING A PODJ THROUGH THE MICROCATHETER; 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 11986478 ↗
• MalfunctionNov 13, 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, A PODJ WOULD NOT ADVANCE INTO THE MICROCATHETER. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PODJS, POD COILS AND THE SAME MICROCATHETER. 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 10839903 ↗
• MalfunctionOct 6, 2020Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (POD PCS). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD PC INTO THE TARGET VESSEL AND DECIDED TO RE-POSITION THE COIL. WHILE RETRACTING THE POD PC, IT BECAME STUCK IN ITS INTRODUCER SHEATH. THEREFORE, THE POD PC WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW COIL. 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 10635365 ↗
• 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 10290788 ↗
• MalfunctionOct 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A TYPE II ENDOLEAK USING A LANTERN DELIVERY MICROCATHETER (LANTERN) AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH THE LANTERN WITH DIRECT PUNCTURE, THE LANTERN WAS KICKED OUT DUE TO THE NEEDLE ACCESS BEING TOO CLOSE IN PROXIMITY TO THE ENDOGRAFT. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO RETRACT THE PODJ. WHILE RETRACTING THE PODJ THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, THE LANTERN CONTAINING THE PODJ WAS REMOVED. UPON REMOVAL, THE LANTERN APPEARED KINKED. THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9253914 ↗
• MalfunctionOct 3, 2019Unraveled Material; Physical Resistance/Sticking; Unraveled Material; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT INTERNAL MAMMARY ARTERIES (RIMA) USING A POD PACKING COILS (PODJ) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PODJ INTO THE TARGET VESSEL USING THE LANTERN; HOWEVER, THE PODJ WAS NOT PACKING AS EXPECTED AND THE PHYSICIAN DECIDED TO REMOVE IT. WHILE RETRACTING THE PODJ THROUGH THE LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE, AND THE PODJ BEGAN TO UNRAVEL. THE PHYSICIAN THEN PULLED THE PODJ AND IT CONTINUED TO UNRAVEL UNTIL IT WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED USING EMBOLIZATION PARTICLES. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152008 ↗
• MalfunctionSep 5, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION IN THE COMMON ILIAC ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED FIVE RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ADVANCING A PODJ INTO THE TARGET VESSEL, THE PHYSICIAN NOTICED THAT PART OF THE PODJ CAME OUT OF THE ANEURYSM; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PODJ. WHILE RETRACTING THE PODJ, NO RESISTANCE WAS EXPERIENCED; HOWEVER, THE PODJ UNINTENTIONALLY DETACHED IN THE LANTERN WITH PART OF THE PODJ INSIDE OF THE INTRODUCER SHEATH; THEREFORE, THE PHYSICIAN SUCCESSFULLY REMOVED THE INTRODUCER SHEATH WITH THE PODJ INSIDE. 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 8965758 ↗
• MalfunctionAug 6, 2019Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE PUSHING A PODJ THROUGH A NON-PENUMBRA MICROCATHETER AND SUBSEQUENTLY, THE PUSHER ASSEMBLY OF THE PODJ KINKED; THEREFORE, THE PODJ WAS REMOVED. 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 8866533 ↗
• MalfunctionMay 24, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE OVARIAN VEIN USING POD PACKING COILS (PODJ). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A NON-PENUMBRA MICROCATHETER, IT BECAME STUCK AND WAS UNABLE TO ADVANCE ANY FURTHER. THEREFORE, THE PODJ AND THE MICROCATHETER WERE REMOVED. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE A NEW PODJ THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), BUT THE SAME ISSUE OCCURRED AND, THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER COILS 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 8641440 ↗
• MalfunctionMay 24, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE AND WAS UNABLE TO ADVANCE A PODJ THROUGH A NON-PENUMBRA MICROCATHETER. THEREFORE, THE PODJ WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW PODJS 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 8640690 ↗
• InjuryDec 20, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A CAVERNOUS CAROTID FISTULA (CCF) IN THE INTERNAL CAROTID ARTERY (ICA) USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, AFTER ADVANCING APPROXIMATELY HALF OF A PODJ INTO THE SAC OF THE FISTULA USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN WAS NOT SATISFIED WITH THE POSITION OF THE PODJ AND DECIDED TO WITHDRAW IT. HOWEVER, WHILE REPOSITIONING, THE PODJ UNINTENTIONALLY DETACHED. THE PHYSICIAN THEN MADE A FEW ATTEMPTS TO PUSH THE REMAINING PODJ INTO THE TARGET VESSEL, BUT WAS UNSUCCESSFUL. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND SUCCESSFULLY SNARED THE PODJ OUT OF THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING OTHER COILS, AN ADDITIONAL 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 8188180 ↗
• MalfunctionSep 20, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A PULMONARY ARTERIOVENOUS FISTULA USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ADVANCING THE LAST PODJ THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PODJ UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN FLUSHED THE DETACHED PODJ INTO THE TARGET VESSEL AND THE PROCEDURE WAS ENDED AT THAT POINT. THERE WAS NO NOTED DAMAGE TO THE LANTERN AND THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7894137 ↗
• MalfunctionSep 18, 2018Mechanical Jam; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE A PODJ, HOWEVER, THE PODJ BECAME STUCK WITHIN THE MICROCATHETER WHILE BEING ADVANCED INTO THE PATIENT. THEREFORE, THE PODJ WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING NEW COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7886927 ↗
• MalfunctionJul 11, 2018Break; Failure to Advance; Physical Resistance/Sticking; Break; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJ'S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL AND A PODJ IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A PODJ WITHIN ITS INTRODUCER SHEATH AND, THEREFORE, THE PODJ WAS REMOVED. HOWEVER, WHILE RETRACTING THE PODJ THROUGH ITS INTRODUCER SHEATH, THE PODJ BROKE. THE PROCEDURE WAS COMPLETED USING ADDITIONAL 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 7679152 ↗
• InjuryApr 23, 2018Detachment Of Device Component; Migration or Expulsion of Device; Detachment Of Device Component; Migration or Expulsion of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TREATING AN ANEURYSM IN A RENAL FISTULA USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET LOCATION USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN ATTEMPTING TO PLACE A PODJ, HOWEVER THEN RETRACTED TO REPOSITION THE PODJ BECAUSE IT WAS DEPLOYING IN THE PARENT VESSEL. WHILE RETRACTING THE PODJ, IT UNINTENTIONALLY DETACHED WHILE PARTIALLY WITHIN THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED PODJ BY RETRACTING THE MICROCATHETER; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN MADE A NEW GROIN PUNCTURE ON THE OTHER SIDE OF THE PATIENT, INSERTED ANOTHER MICROCATHETER, AND PLACED ADDITIONAL COILS AND RUBY COILS TO BLOCK THE DETACHED PODJ FROM GOING INTO THE FLOW. THE PHYSICIAN THEN DEPLOYED AND DETACHED TWO OTHER RUBY COILS. NEXT, THE PHYSICIAN TRIED TO MOVE THE DETACHED PODJ INTO THE TARGET LOCATION BY PUSHING IT WITH ITS PUSHER ASSEMBLY AND ANOTHER COIL PUSHER ASSEMBLY; HOWEVER, IT WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED A SNARE DEVICE AND REMOVED THE DETACHED PODJ FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ADDIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7451259 ↗
• MalfunctionMar 30, 2018Failure to Fold; Device Operates Differently Than Expected; Failure to Fold; Device Operates Differently Than Expected

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A VARICOCELE USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A PODJ INTO THE TARGET VESSEL, THE PODJ AND DID NOT TAKE ITS INTENDED SHAPE; THEREFORE, IT WAS REMOVED AND THE PROCEDURE WAS ENDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7385257 ↗
• MalfunctionFeb 9, 2018Device Damaged Prior to Use; Component Missing; Device Damaged Prior to Use; Component Missing

  WHILE PREPARING A POD PACKING COIL (PODJ) FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF OPENED THE PACKAGING AND NOTICED THAT THE EMBOLIZATION COIL WAS MISSING. THE MISSING EMBOLIZATION COIL WAS NOTICED PRIOR TO USE AND THEREFORE, THE PROCEDURE WAS COMPLETED USING ANOTHER PODJ.

  Patient problems: No Patient Involvement

  MAUDE report 7261626 ↗
• MalfunctionJan 17, 2018Detachment Of Device Component; Device Handling Problem; Detachment Of Device Component; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE LEFT HYPOGASTRIC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE TWO OTHER RUBY COILS THROUGH THE LANTERN, THE HOSPITAL TECHNOLOGISTS INADVERTENTLY KINKED THE COILS PUSHER ASSEMBLIES; THEREFORE, THEY WERE REMOVED. THE PROCEDURE CONTINUED BY PLACING A NEW RUBY COIL IN THE TARGET VESSEL. WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH THE LANTERN, THE HOSPITAL TECHNOLOGIST INADVERTENTLY PULLED THE LANTERN OUT OF THE VESSEL WHICH CAUSED THE COIL TO UNINTENTIONALLY DETACH INSIDE THE LANTERN. THEREFORE, THE LANTERN CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL FLUSHED OUT. 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 Consequences Or Impact To Patient

  MAUDE report 7200837 ↗
• MalfunctionDec 21, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE TO TREAT A LARGE VARICES USING RUBY COILS AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED INITIAL RUBY COILS USING A FORTY-FIVE DEGREE TIP LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A NEW RUBY COIL AND TWO NEW PODJ'S THROUGH THE SAME LANTERN, THE PHYSICIAN ENCOUNTERED RESISTANCE. THEREFORE, ALL THREE COILS WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A TOTAL OF ABOUT TWENTY RUBY COILS AND PODJ'S, THE INITIAL LANTERN AND A NEW LANTERN. IT SHOULD BE NOTED THAT THE PHYSICIAN ONLY SWITCHED OUT THE LANTERN DURING THE PROCEDURE BECAUSE HE NEEDED A DIFFERENT TIP SHAPE. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7139762 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS), POD8S AND POD6S. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PODJ; HOWEVER, UPON RETRACTION, THE PODJ UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY; HOWEVER, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PODJ, A POD8 AND A POD6. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PODJ 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 7131196 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component; Physical Resistance; Detachment Of Device Component; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD PACKING COILS (PODJS), POD8S AND POD6S. IT WAS NOTED THAT THE PATIENT ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN EXPERIENCED RESISTANCE AND DECIDED TO REMOVE THE PODJ; HOWEVER, UPON RETRACTION, THE PODJ UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. AFTER THAT, THE MICROCATHETER WAS REINSERTED INTO THE PATIENT¿S BODY; HOWEVER, IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER PODJ, A POD8 AND A POD6. THE PROCEDURE WAS COMPLETED USING ADDITIONAL PODJ 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 7131146 ↗
• MalfunctionDec 7, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING RUBY COILS AND POD PACKING COILS (PODJ''S). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE AN INITIAL RUBY COIL AND PODJ THROUGH THE NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COILS. THEREFORE, THE RUBY COIL AND PODJ WERE REMOVED AND THE PROCEDURE WAS COMPLETED USING A NEW 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 7097995 ↗
• MalfunctionDec 6, 2017Detachment Of Device Component; Physical Resistance; Device Handling Problem; Detachment Of Device Component; Physical Resistance; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING PREPARATION FOR THE PROCEDURE, THE HOSPITAL TECHNICIAN ACCIDENTALLY KINKED TWO RUBY COILS WHILE ADVANCING THEM INTO THE LANTERN ON THE BACK TABLE. A THIRD RUBY COIL ALSO BECAME KINKED DURING PREPARATION ON THE BACK TABLE. THE DAMAGE TO THESE RUBY COILS OCCURRED PRIOR TO USE, AND THEREFORE THEY WERE NOT USED IN THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS USING THE SAME LANTERN. THE PHYSICIAN THEN EXPERIENCED DIFFICULTY PLACING A PODJ WITHIN THE TARGET LOCATION AND, CONSEQUENTLY, THE PODJ UNINTENTIONALLY DETACHED AS THE PHYSICIAN WAS MANIPULATING IT. THE PHYSICIAN THEREFORE REMOVED THE LANTERN WITH THE PODJ INSIDE, AND THE PROCEDURE WAS COMPLETED USING A NEW LANTERN AND ADDITIONAL RUBY COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7089396 ↗