MICRUSFRAME MFR181240Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704078098), received between Mar 7, 2018 and Mar 4, 2025 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Stretched” (8 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.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING A SPLENIC ARTERY ANEURYSM VIA DOUBLE CATHETER TECHNIQUE, ALL DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TWO (2) MICROCATHETERS, A LEONIS MOVA¿ MICROCATHETER (SUMIMOTO BAKELITE) AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC) WERE ADVANCED TO THE TARGET LESION USING THE PARENT PLUS® GUIDE SHEATH (MEDIKIT) AND A 5FR ANGIOGRAPHY CATHETER (UNSPECIFIED BRAND). IT WAS REPORTED THAT ¿DUE TO THE DEFORMED SHAPE OF THE ANEURYSM,¿ A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 31168427) WAS USED THROUGH THE LEONIS MOVA¿ MICROCATHETER AND THE MICRUSFRAME S THROUGH THE BREAKTHROUGH¿ MICROCATHETER. THE 12MM X 40CM MICRUSFRAME 18 COIL INSERTED THROUGH THE LEONIS MOVA DID NOT HAVE GOOD ENGAGEMENT, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL INTO THE MICROCATHETER FOR REPOSITION. DURING THE RESHEATHING ATTEMPT, THERE WAS NO RESISTANCE, ¿BUT A SENSATION OF ¿SNAPPING¿ WAS FELT MIDWAY. AFTER REMOVAL WITH THE MICROCATHETER, IT WAS FOUND THAT THE COIL HAD SEPARATED AT THE DETACHMENT POINT, AND THE DETACHED COIL WAS RECOVERED FROM WITHIN THE MICROCATHETER. UNRAVEL WAS NOT OBSERVED ON THE RECOVERED C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521111 ↗
• MalfunctionJun 3, 2024Stretched; Difficult to Advance; Material Split, Cut or Torn; Stretched; Difficult to Advance; Material Split, Cut or Torn

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION TARGETING A SPLENIC ARTERY ANEURYSM BY SIMPLE TECHNIQUE, AFTER THE GUIDING CATHETER APPROACHED THE CELIAC ARTERY AND THE MICROCATHETER WAS PLACED INTO THE ANEURYSM, A 12MM X 40CM MICRUSFRAME 18 COIL (MFR181240 / 31168427) WAS CHOSEN AS THE FRAMING COIL. DURING THE WINDING OF THE COIL INSIDE THE ANEURYSM, RESISTANCE WAS FELT WHEN THE COIL WAS MOVED IN AND OUT. THE POSSIBILITY OF COIL UNRAVELING WAS CONSIDERED. AN ATTEMPT TO RESHEATH THE COIL WAS MADE, BUT THE COIL COULD NOT BE RESHEATHED DUE TO THE BROKEN SHEATH. THE COIL WAS RETRIEVED ALONG WITH THE MICROCATHETER. ACCESS WAS ESTABLISHED AGAIN AND THE COIL WAS REPLACED WITH ANOTHER COIL TO COMPLETE THE FRAMING. COIL FILLING WAS CONDUCTED AND THE PROCEDURE WAS COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON 16-MAY-2024, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE REPORTED ISSUE OCCURRED DURING REPOSITIONING IN THE ANEURYSM (WITHDRAWAL / RE-WITHDRAWAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449002 ↗
• MalfunctionJan 25, 2024Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  AS REPORTED BY THE FIELD, THIS WAS AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF INTERNAL ILIAC ARTERY VIA FEMORAL APPROACH. AFTER ELECTRICAL CHECK, COIL EMBOLIZATION WAS INITIATED. WHEN THE MICRUSFRAME18 12MM X 40CM COIL (MFR181240, 30927173) WAS ATTEMPTED TO IMPLANT, DID NOT WIND UP IDEAL, SO THE COIL WAS REMOVED FROM THE PATIENT'S BODY. THE PEELER WAS DAMAGED DURING RE-SHEATH, AND COULD NOT RE-SHEATH THE COIL, SO REPLACED WITH ANOTHER NEW COIL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER PROBLEMS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. A PROWLER SELECT PLUS MICROCATHETER WAS USED. ADDITIONAL EVENT INFORMATION WAS RECEIVED INDICATING THAT THE COIL FAILED TO CONFORM TO THE ANEURYSM WALL. THERE WAS A SPLIT TO THE INTRODUCER, THE DELIVERY WIRE OR COIL DID NOT PROTRUDE. THERE WAS NO RESISTANCE AT ANY TIME DURING ADVANCEMENT OF THE COIL THROUGH THE MICROCATHETER (MC).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580348 ↗
• MalfunctionJul 24, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EXTERNAL CAROTID ARTERY EMBOLIZATION DUE TO A GUNSHOT WOUND, THE PHYSICIAN ENCOUNTERED ISSUES WITH FOUR (4) COILS. THE FIRST TWO COILS, A 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) AND A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 30670821) WOULD NOT DETACH AFTER MORE THAN FIVE (5) CYCLES WERE MADE TO ATTEMPT TO DETACH THEM. THE THIRD COIL, A 1.5MM X 2CM DELTAXSFT 10 (DLX100152 / 30633423) AND THE FOURTH COIL, A 1.5MM X 3CM DELTAXSFT 10 (DLX100153 / 30652463) WOULD NOT ADVANCE DUE TO BROKEN STRING ON THE LOCK MECHANISM. THE PHYSICIAN MOVED TO A DIFFERENT PRODUCT TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON 13-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A MALE UNDER 18 YEARS OF AGE. THE CONCOMITANT MICROCATHETER USED FOR ALL THE COILS WAS A 0.017 ID HEADWAY® DUO 156 MICROCATHETER (MICROVENTION). THE ADDITIONAL INFORMATION RELATED TO THE 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) INDICATED THE FOLLOWING: THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379412 ↗
• MalfunctionJun 15, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AND AFTER CHECKING THE ELECTRICAL CONTINUITY, THE USER ATTEMPTED TO DETACH A MICRUSFRAME18 12MM X 40CM COIL (MFR181240, 30656530) AT THE IMPLANT SITE BUT COULD NOT DETACH, SO THE MICRUSFRAME18 WAS WITHDRAWN. REPLACED THE CONTROL BOX, THE ENPOWERCONTROLCABLE AND MICRUSFRAME18 WITH ANOTHER NEW ONES, AND PERFORMED COIL EMBOLIZATION AGAIN. AFTER THAT, TOTAL 7 COILS COULD BE DETACHED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE. THE LESION WAS UNKNOWN. OTHER CONCOMITANT DEVICE IS MARVEL MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136621 ↗
• MalfunctionDec 29, 2022Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION BEFORE THE ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH THE TARGET LESION ON THE INTERNAL ILIAC ARTERY, THE COMPLAINT COIL, A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 30901846) WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS INTENSIVE RESISTANCE FELT DURING THE DELIVERY VIA CONCOMITANT PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND THE COIL COMPONENT GOT BENT. THE COMPLAINT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 28-DEC-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE CATALOG AND LOT NUMBER OF THE PROWLER SELECT PLUS MICROCATHETER COULD NOT BE OBTAINED, HOWEVER, IT WAS THE SAME MICROCATHETER USED TO COMPLETE THE PROCEDURE. THE REPORTED ISSUE OCCURRED DURING ADVANCEMENT INTO THE TARGET LESION. INFORMATION REGARDING WHETHER A CONTINUOUS FLUSH HAD BEEN MAINTAINED OR IF THE COIL HAD BEEN WITHDRAWN AND REPOSITIONED COULD NOT BE OBTAINED. THE MICROCATHETER WAS NOT REPOSITIONED OVER THE COIL WHILE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16070243 ↗
• MalfunctionMar 30, 2022Retraction Problem; Stretched; Positioning Problem; Retraction Problem; Stretched; Positioning Problem

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION FOR SUBARACHNOID HEMORRHAGE (SAH) USING A DOUBLE CATHETER TECHNIQUE AT THE BASILAR ARTERY (BA TOP). A 12MM X 40CM MICRUSFRAME18 COIL WAS USED TOGETHER WITH A MICROCATHETER (EXSELSIOR SL10). THE COMPLAINT COIL WAS USED AS FRAMING COIL BUT, IT WAS UNABLE TO BE FRAMED AS INTENDED. THE PHYSICIAN ATTEMPTED TO REMOVE IT BUT, IT GOT STUCK ON THE MICROCATHETER AND UNRAVELED. THE ISSUE OCCURRED INSIDE THE MICROCATHETER (MC) THEREFORE, IT WAS REMOVED TOGETHER WITH THE MICROCATHETER. ANOTHER MICROCATHETER AND COIL WERE USED, AND THE PROCEDURE RESUMED AND WAS COMPLETED. THERE WERE NO POST-PROCEDURE CHANGES IN THE PATIENT CONCOMITANT DEVICES ARE A SHEATH INTRODUCER (TERUMO), A GUIDEWIRE (ASAHI), A GUIDING CATHETER (ASAHI), Y CONNECTOR (TERUMO) AND A DETACHMENT DEVICE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13950002 ↗
• MalfunctionAug 30, 2021Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION (PAVM), THE 12MM X 40CM MICRUSFRAME 18 12MM X 40CM COIL (MFR181240 / L15693) WAS USED AS THE SECOND FRAMING COIL. THE COIL WAS DELIVERED BUT WAS NOT ABLE TO BE IMPLANTED AS INTENDED BECAUSE ¿IT WENT TO THE DISTAL REGION.¿ THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL COULD NOT BE RESHEATHED. THE COIL WAS REMOVED FROM THE PATIENT. THERE WAS NO RESISTANCE BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR PATIENT COMPLICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 23 AUGUST 2021 INDICATED THAT THE COIL WAS OUT OF THE TARGET LESION. THIS INFORMATION WAS TO ADD CLARIFICATION TO THE EVENT DESCRIPTION WHERE IT WAS DOCUMENTED THAT THE COIL WAS DELIVERED BUT WAS NOT ABLE TO BE IMPLANTED AS INTENDED BECAUSE ¿IT WENT TO THE DISTAL REGION.¿ BASED ON THE ADDITIONAL EVENT INFORMATION RECEIVED ON 23 AUGUST 2021, THIS EVENT HAS BEEN DEEMED REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389215 ↗
• InjuryAug 12, 2021Material Separation; Stretched; Material Separation; Stretched

  THE EVENT WAS REPORTED VIA VOLUNTARY USER MEDWATCH REPORT (MW5096081). DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2020, THE PHYSICIAN ATTEMPTED TO WITHDRAW A 12MM X 40CM MICRUSFRAME 18 COIL (MFR181240 / L15838), BUT THE COIL STRETCHED AND BROKE. A PORTION OF THE IMPLANT REMAINED IN THE PATIENT FOR A SHORT PERIOD OF TIME, BUT IT ABLE TO BE FULLY RETRIEVED. ON 03 AUGUST 2021, ADDITIONAL INFORMATION WAS RECEIVED. PER THE REPORTING PHYSICIAN, IT WAS AN ARTERIOVENOUS (AV) FISTULA EMBOLIZATION PROCEDURE. MULTIPLE CERENOVUS COILS WERE USED AND THE PHYSICIAN RECALLED SWITCHING OUT A PROWLER LE ES MICROCATHETER DURING THE PROCEDURE AND INTRODUCED THE LANTERN® DELIVERY MICROCATHETER (PENUMBRA) IN THE EVENT HE MIGHT WANT TO USE LARGER RUBY PERIPHERAL COILS; THE LANTERN HAS A 0.025-INCH INNER DIAMETER (ID), WHICH IS LARGER THAN IS INDICATED FOR USE WITH CERENOVUS COILS. THE LANTERN MICROCATHETER WAS NOT VERY SUPPORTIVE AND PROLAPSED ON ITSELF. THE COMBINATION OF THE LARGER ID AND THE PROLAPSING OF THE LANTERN MICROCATHETER CONTRIBUTED TO THE COIL STRETCHING AS THE PHYSICIAN MANIPULATED THE DELIVERY / RETRIEVAL OF THE COIL. THE COIL WAS RETRIEVED WITHOUT INCIDENT AND THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316904 ↗
• InjuryApr 22, 2021Stretched; Separation Failure; Premature Separation; Stretched; Separation Failure; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, A 12MM X 40CM MICRUSFRAME18 (MFR181240/L14780) WAS SELECTED FOR USE AS THE FIRST COIL AND DETACHED AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, WHEN THE DELIVERY WIRE WAS ATTEMPTED TO BE REMOVED, THE EMBOLIC COIL, WHICH WAS SUPPOSED TO HAVE BEEN DETACHED FROM THE DELIVERY WIRE, PULLED OUT CONSIDERABLY INTO THE CONCOMITANT SL-10 (STRYKER) MICROCATHETER. THE PHYSICIAN SUSPECTED THAT THE COIL BECAME SEPARATED AND UNRAVELED. THE EMBOLIC COIL WAS PUSHED OUT OF THE MICROCATHETER INTO THE TARGET ANEURYSM USING A GUIDEWIRE AND THE PROCEDURE WAS CONTINUED. AFTER THE PROCEDURE, THE COIL JUNCTION SEEMED ABNORMAL. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11705860 ↗
• InjuryMar 16, 2021Retraction Problem; Stretched; Positioning Problem; Retraction Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A WIDE-NECKED INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE 12MM X 40CM MICRUSFRAME 18 COIL (MFR181240 / L13530) WAS SELECTED AS THE FIRST COIL AND FRAMING OF THE ANEURYSM WAS PERFORMED; HOWEVER, THE ¿MASS OF THE COMPLAINT COIL LEANED A LITTLE.¿ THE PHYSICIAN ATTEMPTED TO REWIND THE COIL, BUT IT BECAME UNRAVELED AND IT WAS NOT ABLE TO BE WITHDRAWN. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT WITH A SNARE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495916 ↗
• MalfunctionOct 13, 2020Stretched; Separation Failure; Premature Separation; Stretched; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED DURING THE PROCEDURE, THE 12MM X 40CM MICRUSFRAME 18 COIL (MFR181240 / L13777) WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL USING TWO DIFFERENT ENPOWER CONTROL CABLES AND TWO ENPOWER DETACHMENT CONTROL BOXES. THE PHYSICIAN TRIED PULLING THE COIL THROUGH THE MICROCATHETER TO ABORT BUT THE COIL BECAME DETACHED WHEN IT WAS BEING RETRACTED THROUGH THE MICROCATHETER. THE PHYSICIAN OPTED TO USE STRYKER COILS FOR THE REMAINDER OF THE PROCEDURE. THERE WAS NO RESTRICTION OR REDUCTION OF BLOOD FLOW AS A RESULT OF THE REPORTED EVENT. NO EVIDENCE OF THROMBOSIS WAS REPORTED. IT IS NOT KNOWN IF THE PORTION OF THE COIL THAT CAME OUT OF THE PUSHER WIRE WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THE ENPOWER CONTROL CABLES WERE REPORTED AS NOT FUNCTIONING. THE ENPOWER DETACHMENT CONTROL BOXES HAD THE SYSTEM FAULT LIGHT ILLUMINATED RED AT FIRST, BUT THEN ON BOTH BOXES, THE LIGHTS DID TURN GREEN. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE GREEN SYSTEM READY LIGHT DID ILLUMINATE, AND THE AUDIBLE BEEP WAS HEARD DURING THE DETACHMENT CYCLE. THE PHYSICIAN SWITCHED TO STRYKER COILS TO COMPLETE THE PROCEDURE. THE EVENT DID NOT RESULT IN ANY CLIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672094 ↗
• MalfunctionJul 2, 2020Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL ILIAC ARTERY, THE 12MM X 40CM MICRUSFRAME 18 COIL (MFR181240 / L16839) WAS INSERTED INTO THE 150CM X5CM PROWLER SELECT PLUS MICROCATHETER (606S255FX / 30339118), RESISTANCE WAS FELT. THE PHYSICIAN TRIED TO KEEP COILING BUT THE COIL WAS NOT ABLE TO BE PUSHED BACK AND FORTH WHEN IT EXITED THE DISTAL END OF THE MICROCATHETER. THE COIL AND THE CONCOMITANT MICROCATHETER WERE REMOVED FROM THE PATIENT TOGETHER AS A UNIT WHEN IT WAS CONFIRMED THAT THE COIL HAD BECOME DETACHED. THE COIL AND MICROCATHETER WERE REPLACED WITH OTHER DEVICES AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10224857 ↗
• MalfunctionJun 23, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COILING EMBOLIZATION OF AN OF AN ANEURYSM (BASILAR TOP), A 12MM X 40CM MICRUSFRAME COIL (MFR181240, L13777) DID NOT WANT TO DETACH, EVEN AFTER 8 ATTEMPTS. WHEN TRYING TO PULL BACK THE COIL INTO THE SL10 MICROCATHETER (AFTER 2CM), IT FINALLY DID DETACH. THE PHYSICIAN WAS ABLE TO PUT IT BACK INTO THE ANEURYSM. THE DETACHMENT BOX FUNCTIONED WELL FOR THE REST OF THE COIL DETACHMENTS IN THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10183542 ↗
• MalfunctionApr 16, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AT THE RIGHT GASTRIC ARTERY, A 12MM X 40CM MICRUSFRAME18 (MFR181240, L16839) WAS ATTEMPTED TO BE USED, , BUT ITS SIZE DID NOT FIT AND COULD NOT BE RE-SHEATHED, THEREFORE, THE COIL WAS REMOVED. AFTER THAT, THE FRAMING WAS MADE WITH OTHER MICRUSFRAMES COILS. THEN A 8MM X 24CM GALAXY G3 (GLY120824, L15747) WAS ATTEMPTED TO BE USED AS A FILLING COIL, BUT IT GOT STUCK IN THE MICROCATHETER. THEREFORE, THE COMPLAINT COIL WAS REPLACED WITH ANOTHER ONE, AND IT WAS IMPLANTED. THERE WAS ALSO RESISTANCE FELT BETWEEN THE MICROCATHETER AND A 3MM X 8CM GALAXY G3 COIL (GLY120308, L16564). THE PROCEDURE WAS COMPLETED SAFELY. TWO MICROCATHETERS (EXCELCIOR 1018, STRYKER) WERE ALSO USED FOR THIS PROCEDURE. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. A (MM X 12CM DELTAFILL18 COIL HAD BEEN USED AS THE FIRST COIL. BASED ON THE PRODUCT ANALYSIS OF THE 12MM X 40CM MICRUSFRAME18, THE EMBOLIC COIL WAS FOUND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967880 ↗
• MalfunctionSep 19, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, THERE WAS RESISTANCE FELT BETWEEN THE FOLLOWING COILS: 12MM X 40CM MICRUSFRAME18 (MFR181240, L14606), 12MM X 40CM MICRUSFRAME18 (MFR181240, L14780) AND A 10MM X 40CM DELTAFILL18 (DLF181040, L14455) AND A PROWLER SELECT MICROCATHETER (MC) DURING INSERTION, INSIDE THE MICROCATHETER. THE RESISTANCE WAS FELT WITH THE SAME MC. THE BLOOD FLOW WAS VERIFIED BY ANGIOGRAPHY AND THE COMPLAINT COILS WERE NOT INTERRUPTED BY THE FLOW. THEREFORE, THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER COIL AND THE SAME MC WAS USED WITHOUT ANY PROBLEMS. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. PRELIMINARY PHOTOS FROM 3 MICROCOIL SYSTEMS AND A PROWLER SELECT DEVICE WERE RECEIVED ON (B)(4) 2019. BASED ON THE PRELIMINARY PHOTO OBSERVATION, COIL (LOT# L14455) WAS STRETCHED AND ENTANGLED, COIL (LOT# L14606 WAS STRETCHED, AND COIL (LOT# L14780 WAS STRETCHED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COILS WERE UNRAVELED AND TANGLED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087022 ↗
• MalfunctionSep 19, 2019Unraveled Material; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, THERE WAS RESISTANCE FELT BETWEEN THE FOLLOWING COILS: 12MM X 40CM MICRUSFRAME18 (MFR181240, L14606), 12MM X 40CM MICRUSFRAME18 (MFR181240, L14780) AND A 10MM X 40CM DELTAFILL18 (DLF181040, L14455) AND A PROWLER SELECT MICROCATHETER (MC) DURING INSERTION, INSIDE THE MICROCATHETER. THE RESISTANCE WAS FELT WITH THE SAME MC. THE BLOOD FLOW WAS VERIFIED BY ANGIOGRAPHY AND THE COMPLAINT COILS WERE NOT INTERRUPTED BY THE FLOW. THEREFORE, THE PROCEDURE WAS COMPLETED BY REPLACED WITH ANOTHER COIL AND THE SAME MC WAS USED WITHOUT ANY PROBLEMS. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. PRELIMINARY PHOTOS FROM 3 MICROCOIL SYSTEMS AND A PROWLER SELECT DEVICE WERE RECEIVED ON (B)(4) 2019. BASED ON THE PRELIMINARY PHOTO OBSERVATION, COIL (LOT# L14455) WAS STRETCHED AND ENTANGLED, COIL (LOT# L14606 WAS STRETCHED, AND COIL (LOT# L14780 WAS STRETCHED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE COILS WERE UNRAVELED AND TANGLED WHEN REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087019 ↗
• MalfunctionDec 12, 2018Off-Label Use; Separation Failure; Off-Label Use; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), THE 12MM X 40CM MICRUSFRAME18 (MFR181240/L11484) FAILED TO DETACH ALTHOUGH THE ¿DETACH¿ BUTTON WAS PRESSED. THE COIL WAS REPLACED WITH A COIL FROM THE SAME PRODUCT CODE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. AN ENPOWER CONTROL CABLE AND ENPOWER DCB2000500 (DCB2) DETACHMENT CONTROL BOX WERE USED IN THE CASE. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156598 ↗
• MalfunctionNov 20, 2018Difficult to Remove; Stretched; Material Twisted/Bent; Premature Separation; Difficult to Remove; Stretched; Material Twisted/Bent; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE ISSUE OCCURRED DURING THE COIL EMBOLIZATION PROCEDURE OF A SPLANCHNIC ARTERY ANEURYSM AT THE RENAL ARTERY. THE TARGET LESION WAS REPORTED TO HAVE A WIDE NECK AND AS A RESULT, BECAME A BALLOON-ASSISTED COIL EMBOLIZATION PROCEDURE. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) WAS DELIVERED TO THE LESION AND THE COIL EMBOLIZATION PROCEDURE WAS INITIATED. THE FIRST COIL CHOSEN WAS THE MICRUSFRAME 14 8MM X 20CM COIL (MFR181240 / L10592); THE COIL WAS DELIVERED BUT ITS SIZE DID NOT FIT. DURING THE ATTEMPT TO REMOVE THE COIL THROUGH THE MICROCATHETER, THE COIL BECAME DETACHED PREMATURELY INSIDE THE MICROCATHETER; IT WAS CONFIRMED THAT THE PREMATURELY DETACHED COIL DETACHED INSIDE THE MICROCATHETER AND NOT IN THE TARGET LESION. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONTINUOUS FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. IT WAS REPORTED THAT THIS PROCEDURE WAS THE HOSPITAL¿S FIRST TIME USE OF THE SPECTRA COILS. THE PRODU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093212 ↗
• MalfunctionJul 6, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A DURAL FISTULA, THE 12MM X 40CM MICRUSFRAME18 (MFR181240/S10204) COIL COULD NOT BE ADVANCED INTO THE UNSPECIFIED MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT EXIT THE INTRODUCER. THE COIL WAS FLUSHED BUT THE ISSUE CONTINUED. THE COIL WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED TO THE EVENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE INCIDENT. THE DEVICE WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO APPARENT DAMAGE WAS NOTED TO THE COIL UPON REMOVAL. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. THE USER DID NOT APPLY FORCE IN AN ATTEMPT TO GET THE COIL TO EXIT THE INTRODUCER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7666449 ↗
• MalfunctionMar 7, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY AN AFFILIATE, DURING A THORACIC AORTAL STENT-GRAFTING AND THE COIL EMBOLIZATION AT THE LEFT SUBCLAVIAN ARTERY, A MICRISFRAM18S (MFR181240, S12858) WAS INSERTED IN THE LEFT SUBCLAVIAN ARTERY AND THE PHYSICIAN ATTEMPTED TO DETACHED THE COIL. HOWEVER, THE GREEN READY LIGHT WAS NOT ON AND IT COULD NOT DETACH THE COIL. THE MICRUSFRAME WAS NOT FLUSHED TO IMPROVE. THEREFORE, IT WAS REPLACED WITH ANOTHER PRODUCT WITH ANOTHER LOT NUMBER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND HEAVILY CALCIFIED. A MICRO CATHETER (PROGREAT S, TERUMO), A Y CONNECTOR (OKAY, GOODMAN) AND AN EMPOWER CONTROL CABLE WERE ALSO USED FOR THIS PROCEDURE. NO FURTHER INF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7319840 ↗