AZUR 45-880035Recalls & reported problems
Microvention, Inc. · AZUR HydroPack 18 · Class 2 · Implant
All models of AZUR (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Microvention AZUR HydroPack is a vascular coil used to block blood vessels during embolization procedures. There are 23 adverse event reports naming its identifier, with no deaths and 12 injuries. Reports mostly describe the coil detaching inside the delivery catheter before intended, sometimes requiring doctors to fish it out with a snare, and one report mentions a fragment traveling to the spleen. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00842429118061), received between Jan 29, 2024 and Aug 20, 2026 — classified as 12 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Premature Separation” (18 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Premature Separation18
- Unraveled Material2
- Detachment of Device or Device Component1
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Foreign Body In Patient1
- Reduced Blood Flow1
- Thrombosis/Thrombus1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026Premature Separation
As reported during a Visceral embolization, the AZUR Hydropack coil implant was introduced in an embolization procedure. During the procedure, the Hydropack coil was inserted into a Progreat microcatheter and advanced to the target vessel for deployment. The physician tried retracting the coil back into the microcatheter, but the coil prematurely detached. Because of the premature detachment, the coil was left in an undesirable position, so it was necessary to remove it with a snare. The coil was successfully removed with the snare. The patient outcome had no complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50356255 ↗InjuryJun 12, 2026Failure to Advance
AS REPORTED: DURING TRANS-CAVAL EMBO PROCEDURE, A 018 X 150 CM CATHETER WAS ABLE TO CROSS THE AORTIC SAC, NO OTHER CATHETER WAS ABLE TO CROSS. ONCE THE CATHETER REACHED WHERE IT NEEDED TO BE, THE CATHETER WAS FLUSHED AND LOADED WITH THE 35 CM HYDROPACK. THERE WERE NO ISSUES UNTIL THE COIL REACHED THE TIP OF THE CATHETER, SO THE CATHETER WAS PULLED BACK SLIGHTLY. THE COIL WAS STILL UNABLE TO BE PUSHED OUT. WHILE PULING THE COIL OUT, THE PUSHER WIRE APPEARED DETACHED FROM THE COIL. AN ATTEMPT TO FLUSH IN THE COIL WAS WITHOUT SUCCESS. AN ATTEMPT TO PUSH THE COIL IN WITH A WIRE WAS WITHOUT SUCCESS. THE CATHETER WAS PULLED OUT WITH THE COIL INSIDE AND ACCESS TO THE SAC WAS LOST DUE TO THIS ISSUE. THE CASE WAS THEN CALLED DUE TO THE AMOUNT OF TIME IT TOOK TO GET THE CATHETER INTO POSITION AND THEN LOSING ACCESS. THE COIL WAS STRUNG OUT AND PULLED FROM THE CATHETER. THE PATIENT¿S ANEURYSM WAS LEFT UNTREATED WHEN THE PROCEDURE WAS CALLED. IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION. THE PATIENT WAS PLANNED TO BE DISCHARGED AND GO HOME ON THE SAME DAY AS THE PROCEDURE. THE PLAN IS TO HAVE THE PATIENT GET AN ADDITIONAL CT IN 3 MONTHS TO SEE IF THE ANEURYSM SAC IS STILL GROWING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25488431 ↗InjuryApr 27, 2026Premature Separation
IT WAS REPORTED THAT THE COIL IMPLANT WAS BEING USED IN A GASTRODUODENAL ARTERY (GDA) EMBOLIZATION PROCEDURE. REPORTEDLY, THE COIL PREMATURELY DETACHED INSIDE THE MICROCATHETER AFTER COMING ACROSS SIGNIFICANT RESISTANCE TOWARDS THE END OF THE PACK (LAST 10CM OF COIL). THE PHYSICIAN USED A SNARE DEVICE AND REMOVED THE COIL WITH NO ISSUES; AND PROCEEDED TO USE TWO SHORTER 10CM COILS TO COMPLETE THE CASE WITH GREAT SUCCESS. THERE WAS NO REPORT OF INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009639 ↗InjuryFeb 4, 2026Premature Separation
IT WAS REPORTED THAT DURING A PELVIC ANGIOGRAM WITH INTERVENTION, THE PHYSICIAN ACCESSED THE VESSEL OF THE PSEUDOANEURYSM USING A COMPETITOR¿S MICROCATHETER. HOWEVER, THE MICROCATHETER WOULD NOT TAKE A COUPLE OF THE TIGHT TURNS. SO, THE PHYSICIAN PERFORMED AN OVER THE WIRE EXCHANGE USING A DIFFERENT COMPETITOR¿S MICROCATHETER. AFTER A VERY LONG TIME OF UNSUCCESSFUL ATTEMPTS TO WIRE THE OUTFLOW VESSEL, THE MICROCATHETER WAS ADVANCED INTO THE PSEUDOANEURYSM. THE COIL WAS OPENED FOR EMBOLIZATION. WHILE THE PHYSICIAN WAS ADVANCING, WITH APPROXIMATELY 5CM OF THE COIL OUT FROM THE END OF THE MICROCATHETER, THE COIL SEEMED TO LOSE ITS PUSH ABILITY, AND THE MICROCATHETER KICKED BACK. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, BUT IT HAD DETACHED FROM THE PUSHER WIRE WITHIN THE MICROCATHETER. WHEN THE PHYSICIAN TRIED TO REMOVE BOTH THE COIL AND MICROCATHETER TOGETHER, THE MICROCATHETER HAD TO BE PULLED BACK QUITE A BIT BEFORE IT ALIGNED TO THE TIP OF THE MICROCATHETER, WHICH MOVED BACKWARDS. BOTH THE MICROCATHETER AND COIL WERE REMOVED SUCCESSFULLY FROM THE PATIENT. FOLLOWING THE REMOVAL ON THE BACK TABLE, THE PHYSICIAN WAS ABLE TO REMOVE THE REMAINDER OF THE COIL FROM THE FRONT OF THE MIC
Patient problems: Thrombosis/Thrombus
MAUDE report 24264422 ↗MalfunctionDec 16, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PHYSICIAN WAS EMBOLIZING AN EMERGENT GDA BLEED. SHE SUCCESSFULLY DEPLOYED ONE 5X16 AZUR CX. SHE WENT TO PACK IT WITH A 35 CM HYDROPACK AND SHE PUSHED IT OUT OF THE CATHETER. IT WAS HER FIRST TIME USING IT AND IT CAME OUT QUICKER THAN EXPECTED. SHE WENT TO RETRACT THE COIL BECAUSE SHE DID NOT LIKE THE PLACEMENT. ONLY HALF TO 3/4 OF THE COIL WAS IN THE BODY AT THIS POINT. THEY WENT TO PULL IT BACK WITH NO FORCE OF ANY KIND OR MANIPULATION AND THE COIL DETACHED FROM THE PUSHER WIRE. THEY USED A GUIDEWIRE TO PUSH THE COIL OUT OF THE CATHETER AND THE PLACEMENT WAS NOT IDEAL. THE PATIENT OUTCOME WAS REPORTED TO BE "FINE." WHERE THE COIL LANDED WAS DESCRIBED AS "OKAY JUST NOT IDEAL."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824263 ↗InjurySep 16, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT COIL DEPLOYMENT WAS GOING WELL UNTIL THE VESSEL TAPERED DOWN TO ABOUT A 1.5MM. AFTER THAT, THE COIL WOULD NOT FORM. DUE TO RETRACTING AND RE-ADVANCING, THE COIL DETACHED WITHIN MICROCATHETER. THE PHYSICIAN REPORTED THAT THE BROKEN COIL EMBOLIZED TO THE SPLEEN, CAUSING A MINOR INFARCTION. EVERYTHING WAS REMOVED AND THE PHYSICIAN SNARED THE COIL IN THE SPLENIC ARTERY. THE PATIENT OUTCOME WAS REPORTED AS STABLE.
Patient problems: Reduced Blood Flow
MAUDE report 23069174 ↗InjuryJul 15, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT THE COIL BROKE OFF FROM THE PUSHER WIRE INSIDE THE MICROCATHETER. THE OPERATOR WAS TWISTING AND PUSHING THE COIL INTO THE PACK AND IT BROKE OFF. THEY WERE ABLE TO STICK ANOTHER WIRE INTO THE MICROCATHETER AND PUSH IT INTO THE PACK. THIS WAS THE LAST COIL DEPLOYED AND THE CASE WAS FINISHED WITHOUT ANY INCIDENT. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22515978 ↗InjuryJun 19, 2025Premature Separation; Premature Separation
DURING DEPLOYMENT PHYSICIAN FELT THE COIL ''BROKE''. THE COIL AND PUSHER WIRE BECAME SEPARATED AS THE DEVICE WAS PUSHED FORWARD WHICH LED TO COIL BEING ULTIMATELY DEPLOYED IN NON-TARGET AREA. ENTIRE SPLENIC ARTERY WAS EMBOLIZED INSTEAD OF SUB SELECTED BRANCH. AFTER COIL IMPROPERLY DEPLOYED ATTEMPTS WERE MADE TO SNARE IT OUT UNSUCCESSFULLY. UPON ADVANCING A 6FR SHEATH INTO THE SPLENIC. TYPE OF PROCEDURE PERFORMED: SPLENIC ARTERY EMBOLIZATION. PATIENT STATUS IS UNKNOWN AT THIS TIME. THE CASE WAS COMPLETED BY EMBOLIZING THE SPLENIC ARTERY PROXIMALLY WITH 0.035" COILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22294011 ↗InjuryMay 30, 2025Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE PHYSICIAN UTILIZED A 35 CM HYDROPACK IN A COLLATERAL BRANCH, BUT UPON DETACHMENT OF THE COIL, A TAIL FORMED. TO RETRIEVE IT, THE DOCTOR USED A GOOSE NECK SNARE, BUT THE COIL BROKE AND BEGAN TO UNRAVEL. THE REPORTER NOTED THAT THE SNARE CATHETER WAS TOO SMALL TO USE WHEN SNARING THE COIL. AS A SOLUTION, A SECOND ACCESS POINT WAS USED, ALLOWING THEM TO SNARE A PORTION OF THE COIL THAT WAS NOT UNRAVELING. THIS ENABLED THE COMPLETE REMOVAL OF THE 35 CM HYDROPACK THROUGH THE SECONDARY ACCESS ROUTE, SUCCESSFULLY EXTRACTING EVERYTHING THROUGH A 5FR SHEATH. IT WAS REPORTED THAT THE PATIENT OUTCOME WAS FINE. THE CASE WAS FINISHED, AND IT WENT WELL. THE PHYSICIAN THREW THE COIL AWAY. THE PHYSICIAN DIDN¿T SEEM TO THINK IT WAS A DEVICE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22119727 ↗InjuryFeb 25, 2025Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PHYSICIAN WAS DOING A GDA EMBOLIZATION AND DEPLOYED 1 AZUR .018 3MMX8CM COIL FOLLOWED BY THE AZUR HYDROPACK 35CM. AFTER ADVANCING THE HYDROPACK AND WORKING TO REPOSITION THE HYDROPACK, THEY PUT EXTRA TORQUE ON THE PROGREAT 2.4 MICROCATHETER AND THE HYDROPACK SEEMED TO SEPARATE FROM THE FILAMENT WIRE. PART OF THE FILAMENT WIRE ALSO DETACHED AND AFTER ATTEMPTING TO REMOVE THE FILAMENT WIRE WITH A SNARE, THE PHYSICIAN LEFT THE HYDROPACK IN POSITION AND LEFT THE PART OF FILAMENT THAT SEPARATED. THE PHYSICIAN THOUGHT MAYBE THE EXTRA TORQUE AND MANEUVERING OF THE COIL MAY HAVE CAUSED IT TO SEPARATE FROM THE FILAMENT. CASE WAS COMPLETED SUCESSFULLY AND NO ISSUE TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21463721 ↗MalfunctionOct 10, 2024Device Difficult to Setup or Prepare; Premature Separation; Device Difficult to Setup or Prepare; Premature Separation
AS REPORTED: THIS WAS A SPLENIC ARTERY EMBOLIZATION. THE PHYSICIAN WAS TAKING DOWN THE MAIN PORTION OF SPLENIC ARTERY WHICH MEASURED ~5MM DIAMETER. HE HAD IN ADEQUATE SUPPORT AND WAS ACCESSING THE RIGHT FEMORAL. A 2.4F MICROCATHETER WAS USED TO DELIVER THE COILS. HE DEPLOYED A 6X20, 018CX COILS WHICH LANDED PERFECTLY WITH NO ISSUES. THEN HE WENT IN TO DEPLOY THE HYDROPACK. THE PHYSICIAN AND HIS TECH WERE BEING COACHED. THE COIL WAS FLUSHED PRIOR TO REMOVAL FROM THE HOOP, THE INTRODUCER SHEATH WAS INSERTED INTO THE MICROCATHETER HUB, AND NO ISSUES OCCURRED DURING INITIAL ADVANCEMENT. UNDER FLUORO, THE PHYSICIAN ADVANCED THE HYDROPACK TO THE BACKSTOP AND ENSURED THERE WAS ADEQUATE ROOM FOR THE COIL TO COME OUT OF THE MICROCATHETER TO START INITIAL FORM. HE ADVANCED THE MICROCATHETER TO PACK IN THE HYDROPACK AND THEN RETRACTED TO MAKE SPACE FOR ADDITIONAL ADVANCEMENT. ON THE SECOND GO AROUND OF ADVANCING THE HYDROPACK INTO THE PACK, HE SAID HE COULD FEEL THAT THE COIL DETACHED. THE PHYSICIAN STOPPED, CHECKED FLUORO TO CONFIRM LOCATION AND GENTLY TESTED THE PUSHER WIRE TO CONFIRM. THE COIL HAD DETACHED WITHIN THE MICROCATHETER. THE INITIAL PACK THAT HAD FORMED WAS NOT TANGLED IN THE BA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20424735 ↗MalfunctionSep 27, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY DEPLOYED 19 COILS THROUGH THE 2.4 PROGREAT, AND ON THE 20TH COIL, THE HYDROPACK DETACHED FROM THE PUSHER WIRE INSIDE THE PROGREAT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PUSH THE COIL OUT OF THE PROGREAT, BUT THE COIL SHOULD NOT HAVE DETACHED WITHOUT THE CONTROLLER. IT WAS REPORTED THAT THE EVENT DID NOT RESULT IN PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20317677 ↗MalfunctionSep 26, 2024Physical Resistance/Sticking; Premature Separation; Physical Resistance/Sticking; Premature Separation
AS REPORTED: PRIMARY CATHETER INSERTED IN DIRECTION OF TARGET. MICROCATHETER WAS ADVANCED TO TARGET AREA THROUGH PRIMARY CATHETER. PRIOR TO COIL IN QUESTION, A 10CM HYDROPACK WAS SUCCESSFULLY DEPLOYED TO TARGET AREA. COIL IN QUESTION WAS FLUSHED IN STANDARD FASHION BY SCRUB TECH. DOCTOR PLACED COIL INTRODUCING SHEATH NEXT TO PROXIMAL PORTION OF MICROCATHETER. TECH NOTICED RESISTANCE UPON INSERTION AND CONFERRED WITH DOCTOR. DOCTOR DECIDED IT WOULD BE BEST TO REMOVE COIL TO INSPECT. COIL WAS NOT IN STANDARD SHAPE UPON INSPECTION, COIL BREAKAGE WAS SUSPECTED BY THE DOCTOR. A NEW 35CM HYDROPACK WAS OPENED AND SUCCESSFULLY DEPLOYED. OTHER HYDROPACK COILS INSERTED AND SUCCESSFULLY DEPLOYED AFTERWARDS. SUCCESSFUL GDA EMBOLIZATION AS PER DOCTOR AFTER ANGIOGRAPHY PERFORMED. A SEAL WAS USED FOR RIGHT COMMON FEMORAL CLOSURE. PATIENT STABLE POST PROCEDURE. PROCEDURE PERFORMED: GDA EMBOLIZATION VIA RIGHT COMMON FEMORAL ARTERY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20313664 ↗MalfunctionSep 16, 2024Premature Separation; Premature Separation
AS REPORTED: GDA BLEED AND EMBOLIZATION. EVENT WAS DESCRIBED AS UNEXPECTED DETACHMENT OF COIL FROM PUSHER WIRE INTO HEPATIC ARTERY. AFTER FAILED ATTEMPTS, THE COIL WAS NOT RETRIEVED. IT WAS EXPLAINED THAT PLACEMENT OF COIL WAS STILL HELPFUL IN EMBOLIZING THE BLEED. CASE WAS COMPLETED WITH ADDITIONAL AZUR COILS WITH NO ISSUE. ESTIMATED BLOOD LOSS: <250CC. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20228526 ↗MalfunctionSep 3, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE COIL DETACHED BY ITSELF (WITHOUT THE USE OF A CONTROLLER) WHEN TRYING TO REPOSITION. PATIENT STABLE AND COIL SHOT IN WITH SALINE THROUGH THE MICROCATHETER. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20128764 ↗MalfunctionAug 15, 2024Premature Separation; Premature Separation
AS REPORTED: DURING SPLENIC ARTERY EMBO, THE COIL DETACHED (WITHOUT THE USE OF A CONTROLLER) WHILE STILL INSIDE THE MICROCATHETER AND THE ENTIRE CATHETER HAD TO BE REMOVED. CASE COMPLETED BY THE PHYSICIAN INJECTING SALINE THROUGH THE MICROCATHETER TO DEPLOY THE COIL LIKE A PUSHABLE, THE COIL WAS IMPLANTED. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996898 ↗InjuryAug 5, 2024Premature Separation; Premature Separation
AS REPORTED: DURING EMBOLIZATION PROCEDURE, THE COIL DETACHED PREMATURELY WHILE BEING PLACED INSIDE THE PATIENT. THE DR HAD TO GO IN WITH A SNARE TO RETRIEVE THE COIL. NO PATIENT INJURY REPORTED. CASE WAS COMPLETED USING A 20CM HYDROPACK INSTEAD. WAS ABLE TO DEPLOY IT SUCCESSFULLY WITHOUT ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT IS FINE, PROCEDURE WAS A SUCCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19911444 ↗InjuryJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: WHILE POSITIONING/REPOSITIONING COIL, DR. NOTICED A DIFFERENCE IN FEEL. WHILE PULLING COIL BACK UNDER FLUORO, IT WAS NOTED THAT THE PUSHER WIRE DETACHED WHILE STILL IN THE MICROCATHETER. COIL WAS SNARED AND REMOVED FROM PATIENT. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19715639 ↗MalfunctionJul 9, 2024Unraveled Material; Premature Separation; Unraveled Material; Premature Separation
AS REPORTED: UPON TRYING TO DEPLOY THE COIL, THE ACCESS SYSTEM (SHEATH AND CATHETERS) BUCKLED OUT AND BROKE THE PARTIALLY DEPLOYED COIL. UPON ATTEMPTING TO SNARE IT OUT, THE COIL BEGAN TO UNRAVEL. ULTIMATELY, IT WAS UNABLE TO BE COMPLETELY RETRIEVED AND WAS LEFT IN PLACE AS WAS. THE CASE WAS A PULMONARY VEIN EMBOLIZATION. PATIENT IS REPORTED STABLE. PHYSICIAN STATED THAT THE COIL WAS BEING DEPLOYED THROUGH A MICROCATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19707132 ↗InjuryApr 30, 2024Premature Separation; Premature Separation
IT WAS REPORTED THAT THE INTERVENTIONALIST ATTEMPTED TO EMBOLIZE AN ABNORMAL BRANCH OF THE THYROCERVICAL ARTERY IN A PEDIATRIC PATIENT. THIS ARTERY MEASURED ABOUT 2MM DIAMETER WITH 30+MM OF LENGTH. A GLIDE CATHETER AND MICROCATHETER WERE BEING USED. AN ANCHOR COIL WAS SUCCESSFULLY PLACED, FOLLOWED BY AN ATTEMPT TO PLACE A HYDOROPACK COIL. THE COIL DID NOT PACK WELL, LEADING THE INTERVENTIONALIST AND TEAM TO TAKE MULTIPLE ATTEMPTS AT GETTING IT TO PACK AND PLACE PROPERLY IN THE ARTERY. DURING THESE PROLONGED EFFORTS (5-8 REPOSITIONS OVER A MINUTE OR TWO), THE COIL PREMATURELY DETACHED FROM THE PUSHER WIRE WHILE A LONG SEGMENT OF COIL WAS STILL CONTAINED INSIDE THE CATHETERS. THE CATHETER-RETAINED SEGMENT OF COIL EXTENDED ALL THE WAY BACK TO THE ILIAC ARTERY SEGMENT, NEAR TO THE FEMORAL ARTERY ACCESS SITE. AS THE COIL WOULD NOT PACK INTO THE TARGET ARTERY, IT COULD NOT BE SAFELY PUSHED OUT OF THE MICROCATHETER, THUS THE TEAM UNDERWENT ATTEMPTS TO REMOVE THE COIL. WITH THE DISTAL SEGMENT OF THE COIL SECURELY FIXED IN THE COIL PACK IN THE TARGET ARTERY, THE MICROCATHETER WAS REMOVED AND ASPIRATED ON THE JB1 TO EXTERNALIZE THE COIL OUTSIDE THE FEMORAL SHEATH. THE COIL WAS GRABB
Patient problems: Foreign Body In Patient
MAUDE report 19215240 ↗MalfunctionJan 29, 2024Premature Separation; Premature Separation
THIS IS REPORT 2 OF 2. CASE WAS A GDA EMBOLIZATION VIA RIGHT GROIN ACCESS. FIRST A .018 2X4 CX COIL WAS DEPLOYED DISTALLY IN APPROXIMATELY A 1MM VESSEL WITHOUT INCIDENT. NEXT THE EVENT COIL WAS INSERTED INTO THE MICROCATHETER. THE PHYSICIAN WAS HAVING TROUBLE GETTING THE COIL TO TAKE SHAPE AND IT DOUBLED BACK ON ITSELF 2-3 TIMES. THE PHYSICIAN WAS INSTRUCTED TO PULL BACK HIS MICROCATHETER SLIGHTLY TO RELEASE THE TENSION. THE PHYSICIAN THEN FELT A POP AND THE COIL DETACHED WITH ONLY ABOUT 1/3 OF THE COIL OUTSIDE OF THE MICROCATHETER. THE DOCTOR WAS ABLE TO USE THE PUSHER WIRE TO DEPLOY THE REST OF THE COIL OUTSIDE OF THE MICROCATHETER. THE COIL WAS PLACED IN THE INTENDED PLACE. OTHER COILS WERE PLACED IN THE SITE TO FINISH THE CASE SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18603596 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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