POD RBYPOD4Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI M424RBYPOD40), received between Sep 3, 2015 and Sep 8, 2022 — classified as 5 injuries, 115 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET LOCATION AND DETERMINED THE COIL WAS TOO LARGE FOR THE VESSEL; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE POD COIL. HOWEVER, WHILE RETRACTING THE COIL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD COIL HAD UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED AND THE COIL WAS FLUSHED OUT. THE PROCEDURE WAS COMPLETED USING RUBY COILS AND A NEW MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380915 ↗
• MalfunctionApr 5, 2022Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS, RUBY COILS AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE ADVANCING THE POD COIL INTO THE VESSEL. THE PHYSICIAN THEN ATTEMPTED TO REPOSITION THE POD COIL AND ENCOUNTERED RESISTANCE WHILE RETRACTING THE POD COIL. SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED IN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. NEXT, THE PHYSICIAN DECIDED TO USE A RUBY COIL; HOWEVER, THE TECHNICIAN KINKED THE PUSHER ASSEMBLY OF THE RUBY COIL AND NOTICED IT WHILE HANDING THE RUBY COIL TO THE PHYSICIAN. THEREFORE, THE RUBY COIL WAS NOT USED. THE PROCEDURE WAS COMPLETED USING NEW RUBY COILS AND A NEW NON-PENUMBRA MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014941 ↗
• MalfunctionAug 3, 2021Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PROFUNDA FEMORIS ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING THE POD COIL THROUGH THE MICROCATHETER AND SUBSEQUENTLY, THE POD COIL UNINTENTIONALLY DETACHED. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER 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 12271697 ↗
• MalfunctionMay 8, 2021Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING A POD COIL AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, A POD COIL WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11795429 ↗
• MalfunctionDec 13, 2020Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD COILS. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE FIRST POD COIL FROM ITS INITIAL POSITION WITHIN ITS INTRODUCER SHEATH. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD 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 10998024 ↗
• MalfunctionOct 2, 2020Separation Failure; Separation Failure

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING POD COILS, A RUBY COIL DETACHMENT HANDLE (HANDLE) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A POD COIL INTO THE TARGET VESSEL USING THE LANTERN AND ATTEMPTED TO DETACH IT USING THE HANDLE; HOWEVER, THE POD COIL FAILED TO DETACH. THEREFORE, THE POD COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD COIL, RUBY COILS AND THE SAME HANDLE. 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 10623563 ↗
• MalfunctionAug 5, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) USING POD COILS AND PX SLIM DELIVERY MICROCATHETER (PX SLIM). DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE WHILE ADVANCING A POD COIL THROUGH THE PX SLIM. SUBSEQUENTLY, THE POD COIL WAS NOT TAKING ITS INTENDED SHAPE OR ANCHORING WITHIN THE VESSEL. THE PHYSICIAN THEREFORE DECIDED TO REMOVE THE POD COIL; HOWEVER, WHILE RETRACTING, THE POD COIL UNINTENTIONALLY DETACHED INSIDE OF THE PX SLIM. THEREFORE, THE PX SLIM WAS REMOVED CONTAINING THE DETACHED POD COIL. THE PROCEDURE WAS COMPLETED USING A NEW POD COIL AND NEW PX SLIM. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368875 ↗
• MalfunctionFeb 18, 2020Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD4 AND A NON-PENUMBRA MICROCATHETER. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO PROACTIVELY EMBOLIZE THE TARGET VESSEL. DURING THE PROCEDURE, THE POD4 WAS ADVANCED INTO THE TARGET VESSEL; HOWEVER, THE PHYSICIAN DECIDED TO RETRACT THE POD4 TO REPOSITION IT. WHILE RETRACTING THE POD4, THE PHYSICIAN EXPERIENCED RESISTANCE; AND IT WAS NOTICED THAT THE POD4 UNINTENTIONALLY DETACHED INSIDE THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD4 WAS REMOVED AND THE POD4 WAS FLUSHED OUT. SINCE THE PHYSICIAN DID NOT NOTICE AN ACTIVE BLEED, 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 9722661 ↗
• MalfunctionDec 20, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SUPERIOR GLUTEAL ARTERY USING POD4S, A LANTERN DELIVERY MICROCATHETER (LANTERN), AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, THE POD4 WOULD NOT ADVANCE FURTHER THROUGH THE NON-PENUMBRA MICROCATHETER UPON CONTACT WITH BLOOD; THEREFORE, THE NON-PENUMBRA MICROCATHETER AND POD4 WERE REMOVED. THE PHYSICIAN THEN INSERTED THE LANTERN INTO THE PATIENT AND ATTEMPTED TO ADVANCE THE SAME POD4 THROUGH THE LANTERN; HOWEVER, THE SAME ISSUE OCCURRED. THEREFORE, THE POD4 AND LANTERN WERE REMOVED. THE PHYSICIAN THEN SUCCESSFULLY TESTED A NEW POD4 THROUGH THE LANTERN AND THE NON-PENUMBRA MICROCATHETER ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING THE NEW POD4 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 9508078 ↗
• MalfunctionDec 3, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A BRANCH OF THE COLLATERAL VESSEL USING POD4S. DURING THE PROCEDURE, WHILE ADVANCING A POD4 THROUGH A NON-PENUMBRA MICROCATHETER, THE POD4 UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE MICROCATHETER CONTAINING THE DETACHED POD4 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A NEW POD4 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 9406956 ↗
• MalfunctionDec 3, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN WAS REPOSITIONING A POD4 IN THE TARGET VESSEL AND REPORTED THAT IT UNINTENTIONALLY DETACHED. THE POD4 WAS ABLE TO BE IMPLANTED; HOWEVER, THE PHYSICIAN WOULD HAVE PREFERRED IT MORE DISTAL IN THE TARGET VESSEL. THE PHYSICIAN WAS CONTENT WITH THE RESULT; THEREFORE, NO ADDITIONAL COILS WERE IMPLANTED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403714 ↗
• MalfunctionNov 26, 2019Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING A POD4. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A POD4 INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE POD4 WOULD NOT FORM ITS INTENDED SHAPE AND THE MICROCATHETER WOULD KICK OUT OF THE GDA. THEREFORE, THE POD4 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A POD PACKING COIL (POD PC), A 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 9377634 ↗
• MalfunctionOct 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GONADAL VEIN USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE, AND A POD4 WOULD NOT ADVANCE WITHIN ITS INTRODUCER SHEATH; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS 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 9180339 ↗
• MalfunctionSep 5, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY USING POD4S. DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE THE POD4 THROUGH A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE; THEREFORE, THE PHYSICIAN REMOVED THE POD4 AND FLUSHED THE MICROCATHETER. THE POD4 WAS THEN RE-ADVANCED INTO THE SAME MICROCATHETER; HOWEVER, THE PHYSICIAN ENCOUNTERED RESISTANCE AROUND THE SAME AREA, AND THEREFORE, THE POD4 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD4, TWELVE OTHER 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 8965630 ↗
• MalfunctionAug 27, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A RENAL BLEED USING A POD4 AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCING A POD4 THROUGH THE LANTERN, IT BECAME STUCK AND WOULD NOT ADVANCE INSIDE OF THE MICROCATHETER; THEREFORE, BOTH THE POD4 AND LANTERN WERE REMOVED. THE PROCEDURE WAS THEN COMPLETED USING A NEW RUBY COIL AND ANOTHER MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936917 ↗
• MalfunctionAug 13, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING COIL EMBOLIZATION IN THE INFERIOR PHRENIC ARTERY USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHILE ADVANCING AND WITHDRAWING A POD4 AT AN AREA APPROXIMATELY 10 CM FROM THE END OF THE LANTERN. THEREFORE, THE LANTERN AND POD4 WERE REMOVED. NEXT, THE PHYSICIAN ATTEMPTED TO REMOVE THE POD4 FROM WITHIN THE LANTERN OUTSIDE THE PATIENT; HOWEVER RESISTANCE WAS MET; SUBSEQUENTLY THE POD4 BROKE AND THE PHYSICIAN FLUSHED THE POD4 OUT OF THE LANTERN. THE LANTERN WAS REINSERTED AND THE PROCEDURE WAS COMPLETED USING THREE RUBY COILS, FOUR OTHER COILS 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 8888868 ↗
• MalfunctionJul 25, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE SPLENIC ARTERY USING POD4S, POD8S, RUBY COILS, POD PACKING COILS (POD PC), A NON-PENUMBRA GUIDE CATHETER, AND A NON-PENUMBRA MICROCATHETER. DURING THE PROCEDURE, WHILE ADVANCING A POD4 THROUGH THE MICROCATHETER TO THE TARGET VESSEL, THE PHYSICIAN EXPERIENCED RESISTANCE AND THE POD4 WOULD NOT EASILY ADVANCE; THEREFORE, THE POD4 WAS REMOVED. AFTER THAT, THE PHYSICIAN SUCCESSFULLY PLACED NEW POD4S, RUBY COILS, AND POD PCS. WHILE ADVANCING A POD8 THROUGH THE MICROCATHETER, THE SAME ISSUE OCCURRED; THEREFORE, THE POD8 WAS REMOVED. THE PROCEDURE WAS COMPLETED USING OTHER PENUMBRA COILS WITH THE SAME GUIDE CATHETER AND MICROCATHETER. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8827224 ↗
• MalfunctionJul 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A POD4 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN) TO THE TARGET VESSEL; THEREFORE THE POD4 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER POD4. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781257 ↗
• MalfunctionJul 11, 2019Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED RESISTANCE AND WAS UNABLE TO ADVANCE A POD4 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN) TO THE TARGET VESSEL; THEREFORE THE POD4 WAS REMOVED. IT WAS REPORTED THAT THE SAME ISSUE OCCURRED WITH ANOTHER POD4. THE PROCEDURE WAS COMPLETED USING A RUBY COIL AND SAME LANTERN. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8781236 ↗
• MalfunctionMay 8, 2019Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION USING A POD4. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A POD8 AND TWO POD6S IN THE TARGET VESSEL. THE PHYSICIAN THEN WAS UNABLE TO ADVANCE A POD4 THROUGH THE MICROCATHETER. IT WAS REPORTED THAT THE POD4 BECAME ¿LOOSE¿ INSIDE OF THE MICROCATHETER AND THEREFORE, THE POD4 WAS REMOVED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Information

  MAUDE report 8591722 ↗
• MalfunctionFeb 8, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FIRST POD4 INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). HOWEVER, THE LANTERN'S TIP HAD KICKED OUT OF THE VESSEL; THEREFORE, THE PHYSICIAN RETRACTED THE POD4 BACK INTO THE LANTERN TO RE-POSITION THE LANTERN WITHIN THE TARGET VESSEL. WHILE RE-ADVANCING THE POD4 THROUGH THE LANTERN, THE POD4 UNINTENTIONALLY DETACHED WITHIN THE LANTERN. SUBSEQUENTLY, THE LANTERN AND POD4 WERE REMOVED FROM THE PATIENT, THE POD4 WAS REMOVED FROM THE LANTERN, AND THE POD4 WAS NO LONGER USED IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW POD4, THE SAME LANTERN, AND ELEVEN ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8321783 ↗
• MalfunctionDec 31, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY USING POD4S. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE POD4 IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ADVANCING ANOTHER POD4 THROUGH THE MICROCATHETER, THE PHYSICIAN GRADUALLY FELT RESISTANCE AND SUBSEQUENTLY, THE POD4 WOULD NOT ADVANCE BEYOND THE MIDDLE OF THE MICROCATHETER; THEREFORE, IT WAS REMOVED. THE PROCEDURE WAS COMPLETED USING ANOTHER POD4, FOUR PENUMBRA COIL 400S (PC400S) 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 8206756 ↗
• MalfunctionOct 1, 2018Failure to Fold; Premature Separation; Failure to Fold; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY (IIA) USING A POD4. IT WAS NOTED THAT THE PATIENT¿S ANATOMY WAS MILDLY TORTUOUS AND CALCIFIED. DURING THE PROCEDURE, THE PHYSICIAN PLACED THREE PENUMBRA COILS 400 (PC400S) IN THE SUPERIOR GLUTEAL ARTERY USING A LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN PLACED THE LANTERN IN THE INFERIOR GLUTEAL ARTERY AND ATTEMPTED TO DEPLOY A POD4; HOWEVER, THE POD4 WOULD NOT TAKE ITS INTENDED SHAPE. AFTER SEVERAL FAILED ATTEMPTS, THE PHYSICIAN DECIDED TO WITHDRAW THE POD4; HOWEVER, UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE POD4 WAS NOT ATTACHED TO ITS PUSHER ASSEMBLY. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN AND NOTICED THAT THE POD4 HAD UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THE PHYSICIAN THEN REMOVED THE DETACHED COIL AND COMPLETED THE PROCEDURE USING THE SAME LANTERN AND EIGHT PC400S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923581 ↗
• MalfunctionSep 25, 2018Failure to Fold; Failure to Fold

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD4S AND POD PACKING COILS (PODJS). DURING THE PROCEDURE, A POD4 WAS NOT FORMING PROPERLY IN THE TARGET LOCATION AND, THEREFORE, THE POD4 WAS REMOVED. THE PHYSICIAN THEN SUCCESSFULLY DEPLOYED AND DETACHED A RUBY COIL IN THE TARGET LOCATION USING THE SAME LANTERN DELIVERY MICROCATHETER (LANTERN). NEXT, THE PHYSICIAN ATTEMPTED TO PLACE A PODJ; HOWEVER, WHILE ADVANCING THE PODJ INTO THE TARGET LOCATION, THE LANTERN KICKED OUT OF PLACE. THE PODJ WAS THEREFORE REMOVED AND THE PHYSICIAN ADJUSTED THE LANTERN AND ATTEMPTED TO PLACE ANOTHER PODJ. HOWEVER, THE PODJ WAS THE WRONG SIZE. WHILE RETRACTING TO REMOVE THE PODJ, IT UNINTENTIONALLY DETACHED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED PODJ USING A SNARE DEVICE; HOWEVER, THE PODJ BROKE. THE PHYSICIAN WAS ABLE TO REMOVE PART OF THE EMBOLIZATION COIL, AND THE OTHER PART WAS LEFT IN THE PATIENT¿S HEPATIC ARTERY. 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 7906738 ↗
• MalfunctionSep 24, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PULMONARY VEIN USING POD4S. DURING THE PROCEDURE, WHILE ATTEMPTING TO REPOSITION A POD4 THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE POD4 UNINTENTIONALLY DETACHED INSIDE THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED POD4 FROM THE PATIENT AND COMPLETED THE PROCEDURE USING OTHER COILS 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 7903527 ↗