POD RBYPODJ15Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI M424RBYPODJ150), received between May 18, 2016 and Apr 27, 2021 — classified as 3 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2021Separation Failure; Separation Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11734467 ↗
• MalfunctionNov 6, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING RUBY COILS, POD PACKING COILS (POD PCS), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE LANTERN WAS INTRODUCED TO THE TARGET VESSEL AND PENUMBRA COILS WERE IMPLANTED. WHILE ADVANCING A RUBY COIL THROUGH THE LANTERN, THE PHYSICIAN NOTICED THAT THE RUBY COIL PUSHER ASSEMBLY WAS BENT AND DID NOT ALLOW FOR SMOOTH ADVANCEMENT. THEREFORE, THE RUBY COIL WAS REMOVED. NEXT, THE SAME ISSUE OCCURRED WITH A POD PC. THEREFORE, THE POD PC WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL RUBY COILS. 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 10802846 ↗
• MalfunctionJun 26, 2020Break; Break

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, WHILE INSERTING THE PODJ INTO THE MICROCATHETER, THE PODJ DETACHED FROM ITS PUSHER ASSEMBLY, WITH PART OF THE PODJ HANGING OUT OF THE HUB OF THE MICROCATHETER AND THE OTHER PART IN THE OF THE MICROCATHETER. THEREFORE, THE PHYSICIAN USED A MEDICAL INSTRUMENT TO CAREFULLY REMOVE THE PODJ. NO ADDITIONAL INFORMATION REGARDING THE COMPLETION OF THE PROCEDURE WAS PROVIDED. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10198895 ↗
• MalfunctionNov 21, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INTERNAL MAXILLARY ARTERY USING POD PACKING COILS (PODJS) AND A LANTERN DELIVERY MICROCATHETER (LANTERN). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PODJ INTO THE TARGET VESSEL AND PROCEEDED TO RETRACT THE PODJ IN ORDER TO REPOSITION IT. HOWEVER, WHILE RETRACTING THE PODJ, THE PHYSICIAN ENCOUNTERED MINIMAL RESISTANCE AND THE PODJ UNINTENTIONALLY DETACHED WITH PART OF THE PODJ WITHIN THE LANTERN AND THE OTHER PART WITHIN THE PATIENT'S VESSEL. THEREFORE, THE LANTERN AND DETACHED PODJ WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING ANOTHER MICROCATHETER AND COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9355069 ↗
• MalfunctionSep 24, 2019Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RIGHT BRONCHIAL ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ATTEMPTING TO PLACE A PODJ INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN DETERMINED THAT THE PODJ WAS OVERSIZED AND DID NOT FIT IN THE TARGET VESSEL. THE PHYSICIAN THEN MADE SEVERAL ATTEMPTS TO RETRACT THE PODJ; HOWEVER, RESISTANCE WAS ENCOUNTERED AND SUBSEQUENTLY, THE PODJ UNINTENTIONALLY DETACHED WITH HALF OF THE PODJ WITHIN THE VESSEL AND THE OTHER HALF WITHIN THE LANTERN. THEREFORE, THE PHYSICIAN REMOVED THE LANTERN CONTAINING THE DETACHED PODJ AND THEN REMOVED THE PODJ. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND ANOTHER PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9112662 ↗
• InjuryJun 20, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE L1 LUMBAR ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE PLACING A PODJ IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE PHYSICIAN INADVERTENTLY RETRACTED THE LANTERN IN A FAST MANNER AND THE PODJ UNINTENTIONALLY DETACHED. IT WAS REPORTED THAT HALF OF THE PODJ ENDED-UP MORE PROXIMAL TO THE TARGET VESSEL. THEREFORE, THE DETACHED PODJ WAS RETRACTED USING A TRAPPING BALLOON CATHETER. THE PROCEDURE WAS COMPLETED USING THE SAME LANTERN AND A NEW PODJ. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718816 ↗
• InjuryJan 22, 2019Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE INFERIOR MESENTERIC ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A LANTERN DELIVERY MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO PLACE A PODJ, HOWEVER THE COIL UNINTENTIONALLY DETACHED. THEREFORE, THE PHYSICIAN USED A SNARE DEVICE TO REMOVE THE PODJ. THE PROCEDURE WAS THEN 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 8268656 ↗
• MalfunctionNov 21, 2018Accessory Incompatible; Physical Resistance/Sticking; Premature Separation; Accessory Incompatible; Physical Resistance/Sticking; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY PLACED A RUBY COIL USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE ADVANCING A PODJ AND THEREFORE, THE PHYSICIAN ATTEMPTED TO RETRACT THE PODJ. WHILE RETRACTING, THE PHYSICIAN FELT MORE RESISTANCE AND, CONSEQUENTLY, THE PODJ UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THE MICROCATHETER WAS THEN REMOVED WITH THE PODJ INSIDE. IT WAS REPORTED THAT THE NURSE THEN REALIZED THAT THE INNER LUMEN OF THE MICROCATHETER WAS INCOMPATIBLE WITH THIS PODJ. THE PROCEDURE WAS COMPLETED USING ADDITIONAL COILS. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095524 ↗
• MalfunctionOct 10, 2018Premature Separation; Premature Separation

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HEPATIC ARTERY USING POD PACKING COILS (PODJS). IT WAS NOTED THAT THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHILE ADVANCING A PODJ THROUGH A NON-PENUMBRA MICROCATHETER, THE MICROCATHETER KICKED OUT OF THE TARGET VESSEL AND THE PHYSICIAN DECIDED TO RETRACT THE PODJ. HOWEVER, WHILE ATTEMPTING TO RETRACT THE PODJ, IT UNINTENTIONALLY DETACHED WITHIN THE MICROCATHETER. THEREFORE, THE PHYSICIAN REMOVED THE MICROCATHETER AND THE DETACHED COIL TOGETHER. THE PROCEDURE WAS COMPLETED USING 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 7953509 ↗
• MalfunctionAug 28, 2018Failure to Advance; Mechanical Jam; Failure to Advance; Mechanical Jam

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT GASTRIC VARICES USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A LANTERN DELIVERY MICROCATHETER (LANTERN), THE INITIAL PUSHES WERE VERY SMOOTH, BUT THEREAFTER, THE PODJ JUST COMPLETELY STOPPED; THEREFORE, THE LANTERN AND PODJ WERE REMOVED. IT WAS REPORTED THAT THE PODJ INTRODUCER SHEATH MIGHT HAVE NOT BEEN OFF COMPLETELY AND THAT THE PHYSICIAN WAS ACCIDENTALLY PUSHING THE INTRODUCER SHEATH WITH THE PUSHER ASSEMBLY. THE PROCEDURE WAS COMPLETED USING OTHER COILS. THERE WAS NO NOTED DAMAGE TO THE LANTERN AFTER REMOVAL. ADDITIONALLY, THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822917 ↗
• MalfunctionJul 5, 2018Detachment Of Device Component; Mechanical Jam; Detachment Of Device Component; Mechanical Jam

  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 7664555 ↗
• MalfunctionMay 8, 2018Failure to Advance; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A PULMONARY VEIN USING A POD PACKING COIL (PODJ). DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PODJ INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). THE PHYSICIAN THEN RETRACTED THE PODJ IN ORDER TO REPOSITION THE LANTERN; HOWEVER, THE LAST FIVE CENTIMETERS OF THE PODJ BECAME STUCK IN THE INTRODUCER SHEATH WHILE BEING RE-SHEATHED. THEREFORE, THE PODJ WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING ANOTHER 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 7494790 ↗
• MalfunctionApr 9, 2018Detachment Of Device Component; Detachment Of Device Component

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE RENAL ARTERY USING POD PACKING COILS (PODJ¿S). DURING THE PROCEDURE, THE PHYSICIAN DEPLOYED AND DETACHED SIX RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO DEPLOY A PODJ IN THE ANEURYSM, THE LANTERN KICKED OUT THE ANEURYSM; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PODJ IN ORDER TO REPOSITION THE LANTERN. HOWEVER, THE PODJ UNINTENTIONALLY DETACHED IN THE HUB OF THE LANTERN DURING RETRACTION AND THEREFORE, THE PHYSICIAN PULLED THE DETACHED RUBY COIL FROM THE HUB OF THE LANTERN. UPON REPOSITIONING THE LANTERN, THE PHYSICIAN ATTEMPTED TO ADVANCE A NEW PODJ IN THE ANEURYSM; HOWEVER, RESISTANCE WAS ENCOUNTERED APPROXIMATELY HALF WAY INTO THE ANEURYSM AND THE PHYSICIAN ASSUMED THAT THE ANEURYSM WAS GETTING PACKED AT THIS POINT. THEREFORE, THE PODJ WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED USING A 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 7407343 ↗
• MalfunctionFeb 21, 2018Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A DURAL ARTERIOVENOUS FISTULA (D-AVF) USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH A PX SLIM DELIVERY MICROCATHETER (PX SLIM), THE PHYSICIAN EXPERIENCED RESISTANCE; THEREFORE, IT 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 Consequences Or Impact To Patient

  MAUDE report 7286789 ↗
• MalfunctionFeb 12, 2018Retraction Problem; Unraveled Material; Physical Resistance; Retraction Problem; Unraveled Material; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE PHRENIC ARTERY USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS USING A NON-PENUMBRA MICROCATHETER. THE PHYSICIAN THEN FELT RESISTANCE WHILE ADVANCING A PODJ INTO THE HUB OF THE MICROCATHETER, AND THEREFORE ATTEMPTED TO RETRACT AND REMOVE THE PODJ. HOWEVER, THE PODJ WAS UNRAVELLING WHILE BEING RETRACTED. THE PHYSICIAN WAS ABLE TO COMPLETELY REMOVE THE PODJ BY RETRACTING THE PUSHER WIRE, AND 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 Consequences Or Impact To Patient

  MAUDE report 7263822 ↗
• MalfunctionNov 7, 2017Difficult or Delayed Activation; Physical Resistance; Difficult or Delayed Activation; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A BLEED USING POD PACKING COILS (PODJ). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED TWO RUBY COILS IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO ADVANCE A PODJ THROUGH THE LANTERN, THE PHYSICIAN EXPERIENCED SOME FRICTION AND THE PODJ PUSHER ASSEMBLY WOULD NOT PASS ITS INTRODUCER SHEATH. THE PHYSICIAN THEN MADE ANOTHER ATTEMPT AND WAS ABLE TO PASS THE FRICTION AREA AND CONTINUED TO DEPLOY THE PODJ INTO THE TARGET VESSEL. THE PODJ INTRODUCER WAS THEN REMOVED AND THE PODJ WAS COMPLETED ADVANCED INTO THE TARGET VESSEL. AFTER THAT, THE PHYSICIAN DETACHED THE PODJ USING A RUBY COIL DETACHMENT HANDLE (HANDLE) AND WAS PULLING BACK THE PODJ PUSHER ASSEMBLY; HOWEVER, THE PHYSICIAN FELT A BIT OF FRICTION. THEREFORE, THE PHYSICIAN STEPPED ONTO FLUOROSCOPY AND NOTICED THAT THE PODJ WAS NOT DETACHED AND WAS PULLED BACK INTO THE LANTERN. THEREFORE, THE PHYSICIAN PULLED ON THE PULL WIRE, AND THE PODJ WAS DETACHED IN THE LANTERN. THE PODJ PUSHER ASSEMBLY WAS THEN REMOVED AND THE EMBOLIZATION COIL WAS LEFT IN THE LANTERN. THE PHYSICIAN THEN USED A WIRE TO SUCCESSF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008296 ↗
• MalfunctionNov 2, 2017Detachment Of Device Component; Failure to Advance; Detachment Of Device Component; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM USING RUBY COILS, POD PACKING COILS (PODJS), AND A LANTERN DELIVERY MICROCATHETER (LANTERN). IT WAS REPORTED THAT THE PATIENT HAD SOME TORTUOUS ANATOMY, SUCH AS A 360 LOOP, HOWEVER THE REST OF THE VESSEL WAS NAVIGATED AND SUPPORTED BY A DIAGNOSTIC CATHETER. DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED THREE RUBY COILS USING THE LANTERN. AFTERWARDS, THE PHYSICIAN WAS UNABLE TO ADVANCE ANOTHER RUBY COIL OUT OF THE TIP OF THE LANTERN, AND UPON RETRACTION, THE RUBY COIL UNINTENTIONALLY DETACHED WITHIN THE LANTERN. THE PHYSICIAN, THEREFORE, REMOVED THE LANTERN WITH THE RUBY COIL INSIDE AND FLUSHED OUT THE RUBY COIL. THE PHYSICIAN THEN SUCCESSFULLY PLACED MULTIPLE RUBY COILS USING THE SAME LANTERN. HOWEVER, WHILE ATTEMPTING TO PLACE A PODJ, THE PHYSICIAN FOUND THAT THE PODJ WAS UNABLE TO ADVANCE AND BECAME STUCK WITHIN THE LANTERN. THE PODJ THEN UNINTENTIONALLY DETACHED AND THE PHYSICIAN REMOVED THE LANTERN WITH THE PODJ INSIDE. OUTSIDE OF THE PATIENT, THE PHYSICIAN WAS UNABLE TO FLUSH THE PODJ OUT OF THE LANTERN, AND THEREFORE, THE PHYSICIAN COMPLETED THE PROCEDURE USING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6996689 ↗
• MalfunctionOct 26, 2017Component Missing; Out-Of-Box Failure; Incomplete or Missing Packaging; Component Missing; Out-Of-Box Failure; Incomplete or Missing Packaging

  DURING PREPARATION FOR A COIL EMBOLIZATION PROCEDURE, THE HOSPITAL STAFF FOUND THAT THE PRODUCT BOX FOR A POD PACKING COIL (PODJ) WAS EMPTY AND DID NOT CONTAIN THE PODJ INSIDE OF IT. THEREFORE, THE PROCEDURE WAS COMPLETED USING A NEW PENUMBRA DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6979876 ↗
• MalfunctionOct 3, 2017Inadequacy of Device Shape and/or Size; Material Integrity Problem; Device Handling Problem; Inadequacy of Device Shape and/or Size; Material Integrity Problem; Device Handling Problem

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY A PODJ IN THE PATIENT, THE PHYSICIAN DETERMINED THAT THE COIL WAS THE WRONG SIZE AND RETRACTED THE COIL. WHILE ATTEMPTING TO RESHEATH THE PODJ, THE TECHNOLOGIST INADVERTENTLY DAMAGED THE COIL. THEREFORE, THE PODJ WAS NOT REDEPLOYED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IT IS UNKNOWN IF THERE WAS AN ADVERSE EFFECT TO THE PATIENT. PLEASE NOTE THAT THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6912915 ↗
• MalfunctionSep 21, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A SPLENIC BLEED USING POD PACKING COILS (PODJS). DURING THE PROCEDURE, THE PHYSICIAN PLACED INITIAL COILS INTO THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER. WHILE ATTEMPTING TO ADVANCE A NEW PODJ COIL INTO THE SAME MICROCATHETER, THE PHYSICIAN ENCOUNTERED RESISTANCE AND WAS UNABLE TO ADVANCE THE COIL INTO THE MICROCATHETER. THEREFORE, THE INTRODUCER SHEATH CONTAINING THE PODJ WAS REMOVED AND 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 6883782 ↗
• MalfunctionJul 13, 2017Failure to Advance; Physical Resistance; Failure to Advance; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE TO TREAT A GASTRO-DUODENAL ARTERY (GDA) BLEED USING POD PACKING COIL (PODJ). DURING THE PROCEDURE, AFTER ADVANCING ABOUT 55 CM OF PODJ IN THE TARGET VESSEL USING A NON-PENUMBRA MICROCATHETER, THE PHYSICIAN REACHED THE OSTIUM OF THE GDA AND RAN OUT OF SPACE TO DEPLOY THE REMAINING FIVE CENTIMETER. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE PODJ. WHILE ATTEMPTING TO RETRACT THE PODJ, THE PHYSICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE PODJ UNINTENTIONALLY DETACHED FROM THE PUSHER ASSEMBLY WITH FIFTEEN CENTIMETER OF THE COIL IN THE MICROCATHETER. AFTER ATTEMPTING TO REMOVE THE PODJ AND THE MICROCATHETER UNDER ASPIRATION, THE PODJ ENDED UP IN THE COMMON HEPATIC ARTERY. THEREFORE, THE PHYSICIAN USED A MICRO SNARE DEVICE WITH A 5F NON-PENUMBRA CATHETER TO REMOVE THE DETACHED PODJ FROM THE PATIENT'S BODY. IT WAS REPORTED THAT IT TOOK APPROXIMATELY 30 MINUTES TO SNARE THE COIL WHILE ADDING SIGNIFICANT FLUOROSCOPY TIME TO THE CASE. THE PHYSICIAN THEN INSERTED A NEW NON-PENUMBRA MICROCATHETER IN THE TARGET VESSEL AND ATTEMPTED TO LOAD A NEW PODJ; HOWEVER, RESISTANCE WAS ENCOUNTERED AND THE PODJ WOULD NOT ADVANCE THOUGH THE MICRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6710749 ↗
• MalfunctionJul 6, 2017Unraveled Material; Malposition of Device; Unraveled Material; Malposition of Device

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL VESSEL USING POD PACKING COILS (PODJ'S). DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL TECHNICIAN WAS UNABLE TO ADVANCE A PODJ OUT OF ITS INTRODUCER SHEATH ON THE SCRUB TABLE. THEREFORE, THE PODJ WAS SET ASIDE AND A NEW PODJ WAS OPENED. AFTER ADVANCING THE NEW PODJ IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE HOSPITAL TECHNICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT AND PULL THE PODJ OUT OF THE PATIENT. WHILE ATTEMPTING TO RETRACT THE PODJ, THE HOSPITAL TECHNICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE PODJ UNRAVELED. THE HOSPITAL TECHNICIAN WAS ABLE TO REMOVE THE PODJ FROM THE PATIENT WITHOUT ANY ISSUES AND THE PROCEDURE WAS 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 6690013 ↗
• MalfunctionJul 6, 2017Device Damaged Prior to Use; Failure to Advance; Device Damaged Prior to Use; Failure to Advance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN A COLLATERAL VESSEL USING POD PACKING COILS (PODJ'S). DURING THE PROCEDURE, PRIOR TO USE, THE HOSPITAL TECHNICIAN WAS UNABLE TO ADVANCE A PODJ OUT OF ITS INTRODUCER SHEATH ON THE SCRUB TABLE. THEREFORE, THE PODJ WAS SET ASIDE AND A NEW PODJ WAS OPENED. AFTER ADVANCING THE NEW PODJ IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN), THE HOSPITAL TECHNICIAN WAS NOT SATISFIED WITH THE COIL POSITION AND DECIDED TO RETRACT AND PULL THE PODJ OUT OF THE PATIENT. WHILE ATTEMPTING TO RETRACT THE PODJ, THE HOSPITAL TECHNICIAN DID NOT MENTION RESISTANCE; HOWEVER, THE PODJ UNRAVELED. THE HOSPITAL TECHNICIAN WAS ABLE TO REMOVE THE PODJ FROM THE PATIENT WITHOUT ANY ISSUES AND THE PROCEDURE WAS ENDED AT THIS POINT. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 6690010 ↗
• MalfunctionJun 20, 2017Detachment Of Device Component; Premature Activation; Physical Resistance; Detachment Of Device Component; Premature Activation; Physical Resistance

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE GASTRODUODENAL ARTERY (GDA) USING POD PACKING COILS (PODJ''S). DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED AND DETACHED INITIAL RUBY COILS AND POD6''S INTO THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN). WHILE ATTEMPTING TO DEPLOY A NEW PODJ IN THE PATIENT, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THEN ATTEMPTED TO RETRACT THE COIL. HOWEVER, UPON RETRACTION, THE PHYSICIAN NOTICED THAT THE PODJ HAD UNINTENTIONALLY DETACHED. SUBSEQUENTLY, THE PHYSICIAN DECIDED TO LEAVE THE COIL IN THE PATIENT BECAUSE IT WAS CLOSE TO THE TARGET LOCATION AND IN A SAFE LOCATION. THE PROCEDURE WAS THEN COMPLETED USING THE SAME LANTERN, ADDITIONAL RUBY COILS AND POD6''S. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6655654 ↗
• MalfunctionApr 3, 2017Entrapment of Device; Inadequacy of Device Shape and/or Size; Stretched; Entrapment of Device; Inadequacy of Device Shape and/or Size; Stretched

  THE PATIENT WAS UNDERGOING A COIL EMBOLIZATION PROCEDURE IN THE HYPO GASTRIC ARTERY USING POD PACKING COILS (PODJ COILS) AND RUBY COILS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A PODJ IN THE TARGET VESSEL USING A LANTERN DELIVERY MICROCATHETER (LANTERN); HOWEVER, THE PODJ COIL WAS TOO LONG FOR THE ANEURYSM AND THEREFORE, THE PHYSICIAN DECIDED TO REMOVE IT. WHILE REMOVING THE LANTERN AND THE PODJ COIL ALTOGETHER, PART OF THE PODJ COIL WAS OUT OF THE TIP OF THE LANTERN AND GOT CAUGHT WITH THE BASE CATHETER; SUBSEQUENTLY THE PODJ STRETCHED AFTER REMOVAL. THE LANTERN WAS THEN FLUSHED AND RE-INSERTED INTO THE PATIENT¿S BODY. WHILE USING A RUBY COIL WITH THE LANTERN, THE PHYSICIAN LOST ACCESS TO THE TARGET VESSEL AND DECIDED TO REMOVE THE LANTERN AND THE RUBY COIL ALTOGETHER. HOWEVER, WHILE RETRACTING THE LANTERN, PART OF THE RUBY COIL WAS OUT OF THE TIP OF THE LANTERN AND GOT CAUGHT WITH THE BASE CATHETER AND SUBSEQUENTLY, THE RUBY COIL BECAME STRETCHED AFTER REMOVAL. NEXT, THE PHYSICIAN FLUSHED THE LANTERN AND RE-INSERTED IT INTO THE PATIENT¿S BODY. WHILE USING A NEW RUBY COIL WITH THE LANTERN, THE PHYSICIAN LOSS ACCESS IN THE TARGET VESSEL AGAIN AND DECIDED TO WITHDRAW THE RUBY C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6455074 ↗