ApolloTM 105-5096-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 00847536006041), received between May 31, 2019 and Dec 10, 2025 — classified as 11 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Difficult to Remove; Retraction Problem; Detachment of Device or Device Component; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER AUTO DETACHED BY ITSELF BEFORE ONYX COMPLETELY INJECTED. IT WAS REPORTED THE APOLLO CATHETERS TIP PRE-DETACHED. THIS OCCURRED DURING ONYX INJECTION. THE PHYSICIAN HAD A CONTINUOUS INJECTION. THE INJECTION WAITING TIME WAS 2 MINUTES. THERE WAS NO ONYX REFLUX. THE PATIENT WAS UNDERGOING AN EMBOLIZATION FOR AN ARTERIOVENOUS MALFORMATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767414 ↗
• MalfunctionJan 3, 2024Burst Container or Vessel; Device Damaged by Another Device; Burst Container or Vessel; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED REPORTED ONYX WAS NOT USED. THE EVENT WAS NO ASSOCIATED WITH ONYX; NONE HAD BEEN INJECTED. NO CATHETER FRAGMENTS WE LEFT IN THE PATIENT'S BODY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO IMAGES WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436194 ↗
• MalfunctionOct 6, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS BEING TREATED WITH ONYX LES FOR A DURAL ARTERIOVENOUS FISTULA (DAVF) (OFF LABEL). THE DOC WAS GOING UP THE LEFT EXTERNAL CAROTID AND INTO THE MIDDLE MENINGEAL ARTERY (MMA) THEN NOTICED THE CATHETER HAD DETACHED (PRIOR TO THE DETACHABLE TIP). NO ONYX WAS PUSHED YET. THIS WAS AT THE BEGINNING OF THE CASE. THERE WAS CATHETER SEPARATION/BREAK DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE BROKEN LOCATION WAS DISTAL. THE BROKEN SEGMENTS (4-5CM) REMAIN IN THE PATIENT'S LEFT MMA. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF DURAL AV FISTULA WITH ONYX (OFF-LABEL.) IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE LEFT EXTERNAL CAROTID AND MMA. ANCILLARY DEVICES INCLUDE A BENCHMARK 6FR 95CM (LOT # F00007811) GUIDE CATHETER, VECTA

  Patient problems: Foreign Body In Patient

  MAUDE report 17890282 ↗
• InjuryAug 1, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  ADDITIONAL INFORMATION WAS RECEIVED THAT TIP DETACHMENT OCCURRED DURING NAVIGATION THROUGH THE GUIDE CATHETER. THERE WAS NO RESISTANCE WHEN THE APOLLO WAS BEING RETRIEVED AND THERE WAS NO RETRIEVING ATTEMPTED. THE APOLLO TIP WAS NOT EMBEDDED IN THE ONYX CAST AS EMBEDDING IN ONYX HAD NOT STARTED YET. THE CATHETER TIP COULD NOT BE RETRIEVED AND IS IN THE EXTERNAL CAROTID ARTERY. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTED ON ANY OF THE DEVICES.

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 17433853 ↗
• InjuryJun 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS RESISTANCE WHEN THE APOLLO WAS BEING ADVANCED: ANTERIOR CEREBRAL 2 BRANCH (A2). WHEN THE DEVICE WA BEING RECEIVED THE TIP WAS DETACHED WITH NO RESISTANCE. THE APOLLO TIP WAS NOT EMBEDDED IN THE ONYX CAST. IT WAS NOTED THAT THERE MAY BE FUTURE PLANS¿TO RETRIEVE THE CATHETER TIP. THE ANATOMICAL LOCATION OF THE APOLLO TIP: A2. THERE WAS NO NOTE OF VESSEL CALCIFICATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17125468 ↗
• InjuryJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT RECOVERED WELL AFTER THE OPERATION. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT ,ANGIO, ETC.) AVAILABLE. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE PREMATURE TIP DETACHMENT INCLUDED PUSHING THE TIP END THAT HAS BEEN DETACHED PREMATURELY TO THE PART TO BE GLUED. THE PROCEDURE WAS COMPLETED BY PUSHING THE TIP END THAT HAS BEEN DETACHED PREMATURELY TO THE PART TO BE GLUED; REPLACED WITH NEW APOLLO GLUE. THE TIP DETACHMENT OCCURRED DURING NAVIGATION THROUGH THE GUIDE CATHETER. THERE WAS NO RESISTANCE WHEN THE APOLLO WAS BEING ADVANCED. THERE ARE NO¿FUTURE PLANS TO RETRIEVE THE CATHETER TIP. THE ANATOMICAL LOCATION OF THE APOLLO TIP IS IN THE M2. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTICED ON ANY OF THE DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17117156 ↗
• MalfunctionMay 23, 2023Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER WAS OCCLUDED DURING ONYX INJECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. THE ACCESSED VESSEL WAS TO FEMORAL ARTERY WITH A DIAMETER OF 5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT IN THE TREATMENT OF ARTERIOVENOUS MALFORMATION, THE OPERATOR USED DETACHABLE APOLLO CATHETER TO INJECT NEW OSCILLATING ONYX. AT THE END OF THE CATHETER, IT WAS DIFFICULT TO INJECT AND THE CATHETER WAS BLOCKED, SO A NEW CATHETER WAS REPLACED AND THE OPERATION WENT SMOOTHLY. IT WAS REPORTED THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION OF THE CATHETER. IT WAS ALSO REPORTED THERE WAS CATHETER OCCLUSION DURING THE ONYX INJECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANATOMICAL LOCATION OF THE AVM WAS THE INTRACRANIAL OCCIPITAL LOBE. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION OR DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988827 ↗
• MalfunctionMay 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE APOLLO CATHETER WAS KINKED AND DAMAGED. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8.5MM IN DIAMETER. ANCILLARY DEVICES INCLUDE ONYX LIQUID EMBOLIC. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861576 ↗
• MalfunctionApr 27, 2023Compatibility Problem; Compatibility Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS MICROCATHETER BLOCKAGE.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS FISTULA. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH 7.8MM DIAMETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT AFTER THE LIQUID EMBOLIZATION SYSTEM DMSO0.23ML AND ONYX18 WAS INJECTED INTO IN THE MICROCATHETER, THE TIP WAS BLOCKED AND COULD NOT BE INJECTED. CHOSE TO REMOVE THE CATHETER AND REPLACED THE MARATHON. CATHETER OCCLUSION OCCURRED DURING ONYX INJECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS UNKNOWN IF THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. ADDITIONAL INFORMATION RECEIVED. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION OR DIFFICULTY DURING FLUSHING OR INJECTION. THERE WAS NO KINK OR DAMAGE ON THE CATHETER. THERE WAS NO ONYX¿REFLUX. THE PHYSICIAN DID PAUSE DURING INJECTION AND WAITING TIME WAS 2 MINUTES. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16824870 ↗
• InjuryFeb 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT REGARDING GUIDEWIRE RESISTANCE IN THE APOLLO CATHETER AS A RESULT FROM PREMATURE TIP DETACHMENT. THE PATIENT WAS UNDERGOING ARTERIOVENOUS MALFORMATION AND ARTERIOVENOUS FISTULA IN SUPERIOR AND INFERIOR ARTERIOVENOUS MALFORMATIONS IN THE ANTERIOR PARIETAL. THE ACCESSED VESSEL WAS THE FEMORAL ARTERY WITH A ACCESS VESSEL DIAMETER OF 7.3 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT ON (B)(6) 2023, (B)(6) HOSPITAL, DIRECTOR OF NEUROSURGERY GROUP PERFORMED INTERVENTIONAL THERAPY FOR PATIENT WITH INTRAPARIETAL SUPERIOR AND INFERIOR ARTERIOVENOUS MALFORMATION AND ARTERIOVENOUS FISTULA. DURING THE OPERATION, ROUTINE 6F GUIDANCE WAS USED TO ESTABLISH ACCESS TO REACH THE C1 END OF THE INTERNAL CAROTID ARTERY, AND A 0.010 INCH X-PEDION-10 GUIDED FLOATING MICROCATHETER APOLLO WAS USED TO GO UPPER AND REACHED THE A4 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY SMOOTHLY. WHEN THE GUIDE WIRE WAS PLACED IN PLACE AND ENTERED THE SUPERIOR INTERNAL PARIETAL ARTERY, THE OPERATOR REPORTED THAT THE PUSHING TENSION OF THE FLOATING MICROCATHETER WAS VERY HIGH, AND AFTER REPEATED ADJUSTMENTS, IT COULD NOT REACH THE DEFORMED NEST AT THE DISTAL END O

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443086 ↗
• MalfunctionJan 13, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A BREAKAGE IN THE TIP OF THE MICROCATHETER, RESULTING IN ONYX LEAKAGE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157153 ↗
• MalfunctionJan 11, 2023Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED INFOMATION THAT AN APOLLO CATHETER RUPTURED WITH ONYX. DURING THE ONYX PUSHING PROCESS, THE APOLLO CATHETER BURST. FORTUNATELY, THE CATHETER WAS REMOVED IN TIME. THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS BEING TREATED FOR AN ARTERIAL MALFORMATION (AVM). VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 7MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16143256 ↗
• MalfunctionDec 19, 2022Device Damaged by Another Device; Device Damaged by Another Device

  MEDTRONIC RECEIVED INFORMATION THAT AN APOLLO CATHETER WAS TORN WITH THR GUIDEWIRE OR STYLET. APOLLO WAS PLACED NEAR THE NIDUS AND MIRAGE WAS TAKEN OUT. WHILE INJECTING ONYX18, IT WAS SEEN UNDER FLURO THAT MICROCATHETER HAD TORN. THE DAMGE WAS AT THE DISTAL LOCATION. THERE WAS NO FRICTION OR DIFFICULTY DURING INSERTION OF THE GUIDEWIRE OR STYLET. THERE WAS NO OTHER DAMAGE TO THE CATHETER. THERE WAS NO KINK OR DAMAGE TO THE GUIDEWIRE/PUSHWIRE/STYLET. THE DEVICES WERE PREPARED AS PER INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS PER IFU. THE PATIENT WAS UNDERGOING ARTERIOVENOUS MALFORMATION (AVM) TREATMENT. AVM WAS IN M3 SEGMENT AND VESSELS WERE TORTUOUS AND FACED A LITTLE ISSUE TO UNDERSTAND THE FEEDER ARTERIES. VESSEL TORTOUSITY WAS SEVERE. THE ACCESS VESSEL TAS THE LEFT MIDDLE CEREBRAL ARTERY (MCA) WITH A DIAMETER OF 3.7MM. NO PATIENT SYMPTONS OR COMPLICATIONS WERE REPORTED.  ANCILLARY DEVICES: CAT5 (OX) GUIDE CATHETER, MIRAGE WIRE GUIDEWIRE, ONYX 18 LIQUID EMBOLIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16007541 ↗
• MalfunctionNov 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ANATOMICAL LOCATION OF THE APOLLO TIP WAS IN THE MIDDLE MENINGITIS ARTERY. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTICED ON ANY OF THE DEVICES. THE TIP DETACHMENT OCCURRED WHILE TRYING TO NEGOTIATE THROUGH THE TOROUS ANATOMY OF MMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15872401 ↗
• MalfunctionNov 8, 2022Burst Container or Vessel; Compatibility Problem; Burst Container or Vessel; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEAD SPACE OF THE CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION OR OTHER DIFFICULTY OBSERVED DURING FLUSHING OF THE CATHETER OR ONYX INJECTION. THERE WAS NO KINK OR OTHER DAMAGE TO THE CATHETER. THERE WAS NO NOTED ONYX REFLUX. THE INJECTION WAS CONTINUOUS WITHOUT PAUSING AND THE INJECTION RATE WAS FOLLOWED PER THE IFU. NO ONYX WAS IMPLANTED ANYWHERE OTHER THAN THE INTENDED LOCATION. THE DETACHED APOLLO TIME WAS IN THE PATIENT'S LEFT TEMPORAL LOBE. AFTER THE CATHETER RUPTURE, THE EMBOLIZATION CONTINUED UNTIL THE PROCEDURE WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15756653 ↗
• MalfunctionOct 27, 2022Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT AN APOLLO CATHETER WAS SWOLLEN AND HAD SEPARATION DURING PREPARATION. THE PACKAGE AS NOT DAMAGE AND SHOWED NO EVIDENCE OF TAMPERING. THE CATHETER WAS BROKEN IN THE MIDDLE. THE CATHETER WAS FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE DEVICES WERE PREPARED AS PER IFU. THE PATIENT WAS UNDERGOING  ARTERIOVENOUS MALFORMATION (AVM) TREATMENT. VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE POSTERIOR CEREBRAL ARTERY (PCA) WITH A DIAMETER OF 3.5MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678135 ↗
• InjuryOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER TIP PREMATURELY DETACHED AND REMAINED IN THE PATIENT. THE PATIENT WAS UNDERGOING TREATMENT FOR A DURAL ARTERIOVENOUS MALFORMATION (DAVF). THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE MIDDLE MENINGEAL ARTERY, WHICH WAS 1.5MM IN DIAMETER. IT WAS REPORTED THAT THE TIP PREMATURELY DETACHED AT THE SITE OF INJECTION WHEN ONYX WAS PUSHED THROUGH IT. THERE WAS NO FRICTION/DIFFICULTY DURING INJECTION, AND NO FORCE WAS APPLIED DURING REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STUCK AND THERE WAS NO VASOSPASM. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. A CONTINUOUS INJECTION WAS USED, AND THERE WAS NO REFLUX. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR SYMPTOMS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ENVOY GUIDE CATHETER AND HYBRID 007 GUIDEWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15651193 ↗
• MalfunctionOct 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  NEW INFORMATION WAS RECEIVED. THE TIP ATTACHMENT OCCURRED WHEN TAKEN OUT FROM PACKAGE. THE EVENT OCCURRED BEFORE THE PROCEDURE. THERE WAS NO RESISTANCE WHEN THE APOLLO WAS BEING RETRIEVED. THE APOLLO TIP IS NOT EMBEDDED IN THE ONYX CAST. THE APOLLO TIP FELL OUT OF THE BODY. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTICED TO THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15601448 ↗
• MalfunctionOct 12, 2022Burst Container or Vessel; Compatibility Problem; Burst Container or Vessel; Compatibility Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THE DEAD SPACE OF THE CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION OR OTHER DIFFICULTY OBSERVED DURING FLUSHING OF THE CATHETER OR ONYX INJECTION. THERE WAS NO KINK OR OTHER DAMAGE TO THE CATHETER. THERE WAS NO NOTED ONYX REFLUX. THE INJECTION WAS CONTINUOUS WITHOUT PAUSING AND THE INJECTION RATE WAS FOLLOWED PER THE IFU. NO ONYX WAS IMPLANTED ANYWHERE OTHER THAN THE INTENDED LOCATION. THE DETACHED APOLLO TIME WAS IN THE PATIENT'S LEFT TEMPORAL LOBE. AFTER THE CATHETER RUPTURE, THE EMBOLIZATION CONTINUED UNTIL THE PROCEDURE WAS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591987 ↗
• MalfunctionSep 27, 2022Burst Container or Vessel; Compatibility Problem; Burst Container or Vessel; Compatibility Problem

  MEDTRONIC RECEIVED A REPORT THAT A MARATHON AND APOLLO CATHETERS WERE OCCLUDED WHICH PREVENTED ONYX FROM PASSING NORMALLY. AFTER THE CATHETERS WERE REPLACED THE PROCEDURE WENT SMOOTHLY, AND IT WAS STATED THAT THE ISSUE WAS WITH THE CATHETERS. THERE WAS RESISTANCE WITH THE ONYX INJECTION IN THE DISTAL PART OF THE MARATHON CATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ANEURYSM MALFORMATION. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. A CONTINUOUS INJECTION WAS USED, AND THERE WAS NO WAIT TIME AS THE PROBLEM WAS FOUND WHEN INJECTED THE FIRST TUBE OF ONYX. THE DISTAL PART OF THE CATHETER WAS BLOCKED AND HAD A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492587 ↗
• InjurySep 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THEY ATTEMPTED TO GAIN MORE DISTAL ACCESS WITH MICROWIRE AND APOLLO CATHETER, AND THE APOLLO DISTAL TIP DETACHED PRIOR TO ONYX TREATMENT. THERE WAS NO FRICTION. THE TIP REMAINS IN THE PATIENT. NO FORCE WAS APPLIED DURING REMOVAL, THE CATHETER WAS NOT STUCK, THERE WAS NO VASOSPASM, NO SURGICAL INTERVENTION WAS REQUIRED. THIS DID NOT OCCUR DURING ONYX INJECTION. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU AND THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS BEING TREATED FOR AN ATTEMPTED ONYX EMBOLIZATION. THE ACCESS VESSEL WAS THE EXTERNAL CAROTID ARTERY BRANCH. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. ANCILLARY DEVICES INCLUDE A 6F SHUTTLE SHEATH, NAVIEN 058 105CM GUIDE CATHETER, SYNCHRO 10 GUIDEWIRE, MIRAGE GUIDEWIRE, AND CHIKAI 008 GUIDEWIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15459061 ↗
• MalfunctionAug 17, 2022Detachment of Device or Device Component; Physical Resistance/Sticking; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS RESISTANCE BETWEEN THE APOLLO CATHETER AND THE MIRAGE GUIDEWIRE AND THE APOLLO TIP PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING TREATMENT FOR A DURAL ARTERIOVENOUS FISTULA (DAVF). THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE LEFT MIDDLE MENINGEAL ARTERY, WHICH WAS 1.6MM. IT WAS REPORTED THAT THE APOLLO DIDN¿T NAVIGATE ON THE MIRAGE WIRE. THE WIRE WAS CHANGED AND A NEW MIRAGE WIRE WAS USED. AFTER TRYING MANY TIMES, THERE WAS DIFFICULTY IN NAVIGATION OF THE APOLLO ON BOTH MIRAGE WIRES. WHILE NAVIGATING ON NEW WIRE, THE MIRAGE GOT STRETCHED AND APOLLO TIP GOT DETACHED PREMATURELY. THE APOLLO AND MIRAGE BOTH WERE REMOVED. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION, FORCE WAS NOT APPLIED DURING REMOVAL, THE CATHETER TIP WAS NOT ENTRAPPED/STUCK, THERE WAS NO VASOSPASM, AND NO SURGICAL/MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN INFINITY SHEATH AND NEURON GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242361 ↗
• MalfunctionAug 10, 2022Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION REGARDING AN APOLLO CATHETER THAT HAD A LEAK DURING A PROCEDURE. THAT PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM). VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT THE APOLLO CATHETER AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU); THE CATHETER WAS INSPECTED AND TESTED PRIOR TO USE. THE CATHETER WAS FLUSHED PER INSTRUCTIONS FOR USE. DURING INJECTION, IT WAS NOTED THAT THE ONYX WAS STUCK AT THE MIDDLE OF THE CATHETER AND DID NOT CONTINUE TO FLOW TO THE DISTAL END OF THE APOLLO CATHETER. THE SURGEON REMOVED THE WHOLE SYSTEM AND FOUND THAT THE APOLLO CATHETER HAD A LEAK. THE ENTIRE SYSTEM WAS REPLACED TO AVOID LEAKED ONYX FROM FLOWING TO AN UNINTENDED LOCATION. THE DEVICES WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM OR INJURY TO THE PATIENT. ANCILLARY DEVICE: ENVOY GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200765 ↗
• MalfunctionAug 3, 2022Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER HAD A DISTAL LEAK AND AN AXIUM COIL WAS STUCK IN THE CATHETER HUB. THE PATIENT WAS UNDERGOING TREATMENT FOR A SMALL ARTERIOVENOUS MALFORMATION (AVM). THE AVM WAS NOT LOCATED IN THE ELOQUENT REGION. THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8MM IN DIAMETER. IT WAS REPORTED THAT THE SURGEON FOUND THAT THE APOLLO MICROCATHETER TIP LEAKED GLUE DURING THE INJECTION. THEY STOPPED THE OPERATION, AND WITHDREW THE SYSTEM FOR INSPECTION. IT WAS FOUND THAT THERE WAS A LEAK AT THE MICROCATHETER TIP. A REPLACEMENT CATHETER WAS USED. NEXT, THE COIL WAS READY TO BE IMPLANTED TO BLOCK THE BLOOD VESSEL. THE COIL COULD NOT BE DELIVERED INTO THE MICROCATHETER, AND AFTER REPEATED ADJUSTMENT, IT STILL COULD NOT BE SOLVED. THEY REPLACED THE SPRING COIL WITH ONE OF THE SAME MODEL AND IT WAS ABLE TO BE DELIVERED SMOOTHLY. THERE WAS NO DAMAGE TO THE COIL OR CATHETER, AND THE COIL HAD PUSHED OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157341 ↗
• MalfunctionJul 12, 2022Burst Container or Vessel; Burst Container or Vessel

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A RUPTURE AT THE DISTAL END OF THE MICROCATHETER, DURING THE SURGERY, THE GUIDE WIRE CAME OUT OF THE BREAK. THERE WAS NO FRICTION OR DIFFICULTY DURING THE DELIVERY. THERE WAS NO OTHER DAMAGE TO THE CATHETER ASIDE FROM THE RUPTURE. THE ONYX WAS NOT BEING INJECTED AT THE TIME OF THE BREAK, AS THE GUIDE WIRE CAME OUT OF THE BREAK. THE DEVICES USED DURING THE PROCEDURE WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING TREATMENT OF A BRAIN ARTERIOVENOUS MALFORMATION. THE PATIENT HAD NORMAL VESSEL TORTUOSITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988825 ↗