MICRUSFRAME MFR100626Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886704077862), received between Dec 21, 2017 and Aug 5, 2024 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Kinked” (5 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2024Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, ¿MATERIAL FAILS TO PASS THROUGH THE MICROCATHETER.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. PER THE SOURCE FILE INCLUDED IN THE COMPLAINT ON 18-JUL-2024, THE PATIENT UNDERWENT THE PROCEDURE AT SAN JOSÉ CHILDREN'S HOSPITAL ON (B)(6) 2024, IN THE MORNING HOURS, FOR AN EMBOLIZATION OF AN ANEURYSM IN THE BASILAR ARTERY. THE PHYSICIANS ACCESSED THE TARGET ANEURYSM USING AN ENVOY DA GUIDE CATHETER (CATALOG / LOT# UNKNOWN) AND THE PROWLER SELECT LPES MICROCATHETER (606S155X / LOT# UNKNOWN) FOR THE DELIVERY OF THE COILS. FOR THIS PROCEDURE, APPROXIMATELY 6 ¿ 7 COILS WERE REQUIRED, OF WHICH, 2 WERE CERENOVUS COILS: ONE OF THE COILS, A 6MM X 26CM MICRUSFRAME 10 (MFR100626 / 31071519) COULD NOT PASS THROUGH THE MICROCATHETER. PER THE SOURCE FILE, DURING THE PROCEDURE, OTHER COMPETITOR COILS WERE INTRODUCED AND PASSED THROUGH THE MICROCATHETER WITHOUT ANY ISSUE. ON 22-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PATIENT IS AN 18-YEAR-OLD FEMALE WITH A HISTORY OF ANEURYSM. THE PROCEDURE WAS TARGETING A LARGE FUSIFORM ANEURYSM ON THE ¿VASCULAR ARTERY, LEAVING THE PICA B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908007 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 42-YEAR-OLD FEMALE (B)(6) WITH NO TARGETED MEDICAL HISTORY, EXCEPT BEING A SMOKER, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT ANEURYSM IN THE BIFURCATION OF THE INTERNAL CAROTID ARTERY ON (B)(6) 2021. THE PATIENT¿S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED ON (B)(6) 2021, THE DIMENSIONS OF THE ANEURYSM WERE AS FOLLOWS: ANEURYSM HEIGHT 5.1MM, DOME 6.3MM, MAXIMUM ANEURYSM DIAMETER 6.3MM, NECK SIZE 1.9MM, AND THE DOME-TO-NECK RATIO OF 3.3MM. THE PARENT VESSEL DIAMETER WAS NOT DONE. THE FOLLOWING COILS WERE IMPLANTED VIA AN ECHELON 10 MICROCATHETER (MEDTRONIC): ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/ 30532733), ONE 4MM X 12CM GALAXY G3 (GLY120412/30541491), ONE 2.5MM X 3.5CM GALAXY G3 XSFT (GLX122535/30546472), ONE 2MM X 4MM GALAXY G3 MINI (GLM920040/30558132), ONE 1.5MM X 2CM GALAXY G3 MINI (GLM915020/30558365), AND ONE 2MM X 2MM GALAXY G3 XSFT (GLX120202/L16466). ONE 2.5MM X 2.5CM GALAXY G3 XSFT (GLX122525/30541484) WAS USED, BUT NOT IMPLANTED. MICROCATHETER KICKBACK (LOSS OF ACCESS TO ANEURYSM) WAS EXPERIENCED A TOTAL OF THREE TIMES. HEPARIN WAS ADMINISTERED DU

  Patient problems: Ruptured Aneurysm

  MAUDE report 14516594 ↗
• MalfunctionJul 27, 2021Retraction Problem; Retraction Problem

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INTERNAL CAROTID, THERE WAS WITHDRAW DIFFICULTIES WITH A WITH A MICRUSFRAME10 6MM X 26CM COIL (MFR100626, 30393975). THE MICRO COIL DID NOT GO OUT DISTALITY OF EXCELSIOR SL-10 MICROCATHETER (M0031681890). THERE WAS A CRACK/TEAR IN THE MICROCATHETER, THEREFORE, THE COIL ¿STAYED STUCK¿. THE COIL WAS REMOVED NORMALLY FROM THE PATIENT. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. NO OBSTRUCTIVE OBJECTS WERE REPORTED BY USERS. THE DEVICE WAS USED IN THE USUAL WAY BY PROFESSIONALS TRAINED AND FAMILIAR WITH IT¿S USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12229416 ↗
• MalfunctionSep 23, 2020Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE LEFT OPHTHALMIC, AN EMPOWER CONTROL CABLE (CATALOG/LOT NUMBER UNKNOWN) COULDN'T SEAT PROPERLY WITH THE ENPOWER DCB 2 OUTPUT CONNECTOR; THE DCB OUTPUT CONNECTOR APPEARED DAMAGE. THE CABLE WAS ULTIMATELY ABLE TO CONNECT TO THE DCB CONNECTOR, BUT IT'S UNCLEAR IF THE USER FELT THE ACTUAL CLICK ON ATTEMPT TO CONNECT. THE CABLE WAS REPLACED BUT THE ISSUE CONTINUED. THE 6MM X 26CM MICRUSFRAME10 COIL (MFR100626, 30370540) WAS SUBSEQUENTLY REMOVED FROM THE PATIENT AND BOTH THE DCB AND COIL WERE REPLACED TO COMPLETE THE PROCEDURE. THE COIL WAS NOT RE-CHALLENGED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE(S) WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10573892 ↗
• InjuryJul 14, 2020Separation Failure; Premature Separation; Separation Failure; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A BASILAR TIP ANEURYSM, A 6MM X 26CM MICRUSFRAME10 (MFR100626/UNKNOWN LOT #) COIL WAS ATTEMPTED TO BE DETACHED USING THE ENPOWER CONTROL CABLE (ECB00018200/K10545) BUT THE COIL FAILED TO DETACH. THEREFORE, THE DETACHMENT CONTROL BOX (UNKNOWN PRODUCT CODE & LOT #) WAS REPLACED BUT THE SAME ISSUE CONTINUED. THE ENPOWER CONTROL CABLE WAS THEN REPLACED BUT THE COIL WOULD NOT DETACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL FROM THE PATIENT, BUT THE COIL UNINTENDEDLY DETACHED IN THE MICROCATHETER. A GUIDEWIRE WAS USED TO PUSH THE COIL INTO THE ANEURYSM AND THE COIL WAS IMPLANTED. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: No Code Available

  MAUDE report 10270205 ↗
• InjuryJul 7, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  AS REPORTED BY THE (B)(6) STUDY, A (B)(6) MALE (SUBJECT (B)(6)) WITH A HISTORY OF HEADACHES AND SMOKING (CURRENT) UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT POSTERIOR CEREBRAL ARTERY ANEURYSM ON (B)(6) 2019 AND EXPERIENCED ANEURYSM RECANALIZATION ON (B)(6) 2020 REQUIRING REPEAT COIL EMBOLIZATION ON (B)(6) 2020. IMMEDIATE PRE-PROCEDURE ANGIOGRAPHY ON (B)(6) 2019 REVEALED A RIGHT PCA BIFURCATION ANEURYSM. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 11.8MM, DOME 9.6MM, MAXIMUM ANEURYSM DIAMETER 9.6MM, NECK SIZE 5.0MM, AND DOME-TO-NECK RATIO 1.9MM. PARENT VESSEL DIAMETER WAS 2.0MM. BALLOON-ASSISTED COIL EMBOLIZATION WAS SUBSEQUENTLY PERFORMED WITH THE IMPLANTATION OF ONE 3MM X 8CM GALAXY G3 XSFT (GLX120308/L13627), ONE 3.5MM X 9CM GALAXY G3 XSFT (GLX123509/L12045), ONE 4MM X 8CM GALAXY G3 XSFT (GLX120408/L13272), ONE 4MM X 10CM GALAXY G3 XSFT (GLX120410/L13817), ONE 5MM X 10CM GALAXY G3 (GLY120510/L13038), ONE 6MM X 11.9CM MICRUSFRAME10 (MFR100611/L15887), ONE 6MM X 26CM MICRUSFRAME10 (MFR100626/L15266), ONE 9MM X 22CM MICRUSFRAME14 (MFR140922/L15601), ONE 2MM X 6CM GALAXY G3 XSFT HEL (GLX120206/L11700), AND ONE 2MM X 8CM GALAXY G3 XSFT HEL (GLX120208/L137

  Patient problems: No Code Available

  MAUDE report 10239868 ↗
• MalfunctionApr 28, 2020Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN INTRACRANIAL COIL EMBOLIZATION, TWO A 4X5MM MICRUSFRAME COILS WERE USED SUCCESSFULLY AS THE FIRST AND SECOND COILS WITH A HEADWAY 17 MICROCATHETER (MC). HOWEVER, A 6MM X 15CM GALAXY G3 COIL (GLY120615, L16321), A 6MM X 11.9CM MICRUSFRAME10 COIL (MFR100611, L10198) AND A 6MM X 26CM MICRUSFRAME10 COIL (MFR100626, L10199) BECAME STUCK WITH THE MC. THE PHYSICIAN REMOVED THE COILS THROUGH THE MC AND COMPLETED THE PROCEDURE SUCCESSFULLY BY USING THE SAME MC AND A COMPETITOR¿S COIL. IT IS UNKNOWN IF THE EVENT RESULTED IN A LOSS OF CEREBRAL TARGET POSITION. THERE WAS NO PATIENT CONSEQUENCES. THE SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE REPORTED EVENTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT ALL THREE COILS WERE STRETCHED AFTER WITHDRAWING. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE COIL OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. FIRST, RESISTANCE WAS FELT AND THEN THE DEVICE WAS TOTALLY BEFORE FLUORO SAFE DISTANCE WAS SOMETHING 20 CM FROM RHV. THERE WAS NO NOTICE OF ANYTHING OBSTRUCTING THE MICROCATHETER. CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005314 ↗
• MalfunctionMar 9, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, BOTH COILS, A 6MM X 26CM (MFR100626, L14994) AND A 6MM X 26CM MICRUSFRAME10 (MFR100626, L12763) COULD NOT BE PUSHED OUT OF THE CATHETER IN THE PATIENT. THE COILS WERE NOT PREVIOUSLY TESTED IN THE WATER BASIN. CATHETER WAS THEN REMOVED FROM THE PATIENT AND AGAIN THE COILS COULD NOT BE PUSHED OUT OF THE CATHETER. AFTERWARDS, HOWEVER, IT WAS POSSIBLE TO CONTINUE COILING WITH ANOTHER NONSPECIFIC COIL WITHOUT ANY PROBLEMS. AT NO TIME WAS THERE ANY DANGER TO THE PATIENT. NO PATIENT HARM NOR SIGNIFICANT DELAY WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS WAS AN INTRACRANIAL PROCEDURE. THE DEVICES WERE STUCK AT THE HUB OF THE MICROCATHETER (MC). IT WAS ¿NOT CHECKED¿ IF THE COILS OR DELIVERY SYSTEMS WERE DAMAGED DUE TO THE RESISTANCE OR IF THERE WAS EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE DEVICES WERE NOT ABLE TO BE REMOVED FROM THE MC. THE DEVICES NOR THE MICROCATHETER BECAME KINKED OR BEND PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. A MICROKATHETER EXCELSIOR 10 (MEDTRONIC) AND A NEURON 070 6F (PENUMBRA) GC WERE USED DURING THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806471 ↗
• MalfunctionMar 9, 2020Failure to Advance; Failure to Advance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, BOTH COILS, A 6MM X 26CM (MFR100626, L14994) AND A 6MM X 26CM MICRUSFRAME10 (MFR100626, L12763) COULD NOT BE PUSHED OUT OF THE CATHETER IN THE PATIENT. THE COILS WERE NOT PREVIOUSLY TESTED IN THE WATER BASIN. CATHETER WAS THEN REMOVED FROM THE PATIENT AND AGAIN THE COILS COULD NOT BE PUSHED OUT OF THE CATHETER. AFTERWARDS, HOWEVER, IT WAS POSSIBLE TO CONTINUE COILING WITH ANOTHER NONSPECIFIC COIL WITHOUT ANY PROBLEMS. AT NO TIME WAS THERE ANY DANGER TO THE PATIENT. NO PATIENT HARM NOR SIGNIFICANT DELAY WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THIS WAS AN INTRACRANIAL PROCEDURE. THE DEVICES WERE STUCK AT THE HUB OF THE MICROCATHETER (MC). IT WAS ¿NOT CHECKED¿ IF THE COILS OR DELIVERY SYSTEMS WERE DAMAGED DUE TO THE RESISTANCE OR IF THERE WAS EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICES. THE DEVICES WERE NOT ABLE TO BE REMOVED FROM THE MC. THE DEVICES NOR THE MICROCATHETER BECAME KINKED OR BEND PRIOR TO THE RESISTANCE OR NOTED AFTER REMOVAL FROM THE PATIENT. ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED. A MICROCATHETER EXCELSIOR 10 (MEDTRONIC) AND A NEURON 070 6F (PENUMBRA) GC WERE USED DURING THE PROCED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806428 ↗
• MalfunctionAug 1, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION TO THE LEFT MIDDLE CEREBRAL ARTERY (MCA), A 6MM X 26CM MICRUSFRAME10 COIL (MFR100626, L13454) DID NOT ¿SLIP¿ ON THE ECHELON 10. MICROCATHETER (MC). THE EVENT OCCURRED 10 OR 15CM AFTER THE HUB. IT WAS NOT POSSIBLE TO POSITION IT ON THE ANEURYSM. THE USER TOOK OUT THE COIL AND THE MICROCATHETER TO CHECK IF THE ISSUE CAME FROM THE COIL OR THE MC, BUT NO KINK ON THE MC. THERE WAS NO PATIENT INJURY REPORTED. ANOTHER MICRUSFRAME10 COIL FROM ANOTHER LOT WAS USED PERFECTLY WITH THE SAME MC. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY DUE TO THE EVENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE COIL DID NOT EXIT THE CATHETER. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THERE WAS NO DIFFICULTY DURING INTRODUCTION OF THE CATHETER OVER THE GUIDE WIRE PRIOR TO THE ATTEMPTED USE OF THE DEVICE. THE MICROCATHETER HAD NO KINKED OR BENT AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE COIL WAS STILL ATTACHED TO THE DEVICE AND THERE WAS NO ACTUAL DAMAGE NOTED ON THE DEVICE WHEN REMOVED FROM THE PATIENT. THE VESSEL WAS NOT EXCESSIVELY TORTUOUS OR WITH ACUTE BENDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851220 ↗
• MalfunctionFeb 27, 2019Positioning Problem; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TO TREAT A SUBARACHNOID HEMORRHAGE (SAH) OF AN ANEURYSM AT THE INTERNAL CAROTID-POSTERIOR COMMUNICATING ARTERY (IC-PC), THE 6MM X 26CM MICRUSFRAME 10 COIL (MFR100626 / S13305) WAS USED AS A FRAMING COIL; THE COIL WAS DEPLOYED THROUGH THE SL-10® MICROCATHETER (STRYKER), BUT THERE WAS POOR COIL CONFORMABILITY AND THE COIL SHAPE DID NOT FIT THE TARGET LESION. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE INTRODUCER SHEATH BECAME DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE MICRUSFRAME 10 COIL WAS REPLACED WITH ANOTHER OF THE SAME SIZE AND THE REPLACEMENT FRAMING COIL WAS SUCCESSFULLY IMPLANTED IN THE TARGET LESION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY WITH ADDITIONAL COILS SUCCESSFULLY IMPLANTED AT THE TARGET LESION. IT WAS CONFIRMED THAT THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY; THERE WAS NO ISSUE ENCOUNTERED DURING THE UNSHEATHING (STRIPPING AWAY) OF THE COIL INTRODUCER TUBE OF THE DETACHABLE COIL SYSTEM (DCS). THE COIL INTRODUCER WAS NOT DAMAGED IN ANYWAY PRIOR TO USE. EXCESSIVE FORCE WAS NOT USED DURING THE UNSHEATHING OR RESHEATHING

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8376379 ↗
• MalfunctionNov 28, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR A SUBARACHNOID HEMORRHAGE, THE MICRUSFRAME 10 6MM X 26CM COIL (MFR100626 / S11934) WAS USED BUT RESISTANCE WAS FELT DURING THE COIL ADVANCEMENT FOR DELIVERY THROUGH THE MICROCATHETER (NEURODEO®, MEDICO¿S HIRATA) AT THE PROXIMAL PORTION BEFORE THE COIL PASSED THROUGH THE HUB OF THE MICROCATHETER. IT WAS REPORTED THAT THE RESISTANCE WAS LIKELY INSIDE THE INTRODUCER SHEATH. THE MICRUSFRAME 10 6MM X 26CM COIL WAS REPLACED WITH A COMPETITIVE PRODUCT AND THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. 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 CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. IT WAS REPORTED THAT THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8113628 ↗
• MalfunctionNov 13, 2018Difficult to Remove; Unraveled Material; Material Twisted/Bent; Difficult to Remove; Unraveled Material; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BASILAR ARTERY-SUPERIOR CEREBELLAR ARTERY (BA-SCA) ANEURYSM, THE 6MM X 26CM MICRUSFRAME10 (MFR100626/S14061) THERMO-MECHANICAL COIL WAS SELECTED FOR USE AS A FRAMING COIL AND DELIVERED TO THE TARGET LESION, BUT WHEN THE PHYSICIAN ATTEMPTED TO POSITION THE COIL, IT TANGLED AND UNRAVELED. THEREFORE, IT WAS REMOVED WITH THE CONCOMITANT EXCELSIOR XT-27 (STRYKER) MICROCATHETER AND REPLACED WITH A 5MM X 17CM MICRUSFRAME COIL. FRAMING WAS CONDUCTED, AND THREE COMPETITOR COILS WERE IMPLANTED. 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. THE PRODUCT WAS DISCARDED AND IS THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8067439 ↗
• MalfunctionSep 20, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE EMERGENCY COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM DUE TO A GASTROINTESTINAL BLEEDING, THE MICRUSFRAME 10 6MM X 26CM COIL (MFR100626 / S13590) COULD NOT BE ADVANCED AT THE DISTAL PORTION OF THE INTRODUCER SHEATH. THE PHYSICIAN ATTEMPTED TO MOVE THE COIL SEVERAL TIMES, AND THE COIL BECAME UNRAVELED. THE COIL ENTIRE COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL OF A DIFFERENT SIZE AND THE PROCEDURE CONTINUED TO SUCCESSFUL COMPLETION WITHOUT FURTHER ISSUES OR DELAY USING SEVERAL COILS OF DIFFERENT SIZES. 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 CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE MICRUSFRAME 10 10 6MM X 26CM COIL WAS REPORTED AS NOT AVAILABLE TO BE RETURNED FOR PRODUCT EVALUATION AND ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895701 ↗
• MalfunctionAug 28, 2018Stretched; Material Deformation; Stretched; Material Deformation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM FOR AN ARTERIOVENOUS MALFORMATION (AVM), THE PRE-TREATMENT HISTOACRYL MATERIAL FLOWED INTO THE OA FEEDER AND THE COILS (STRYKER, TARGET XL 360 SOFT 3 X 9 AND 5 X 15) WERE PLACED IN TO THE LESION. THE MICRUSFRAME 10 6MM X 26CM COIL (MFR100626 / S11575) WAS INSERTED BUT THE COIL DID NOT COME OUT OF THE SHEATH. THE DELIVERY WIRE WAS EXPOSED AT THE MIDDLE PORTION OF THE SHEATH. THE MICRUSFRAME COIL WAS REPLACED WITH ANOTHER MICRUSFRAME (MICRUSFRAME 18 8 X 30). HISTOCRYL WAS INTRODUCED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. NO EXCESSIVE FORCE WAS USED AT ANY TIME DURING THE PROCEDURE. 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 CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WAS RETURNED FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7822947 ↗
• MalfunctionAug 23, 2018Stretched; Material Deformation; Stretched; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMERGENT COIL EMBOLIZATION OF A 3 MM CELIAC ARTERY PSEUDOANEURYSM (POST-GASTRIC SURGICAL OPERATION), THE 6 MM X 26 CM MICRUSFRAME10 (MFR100626/S13401) THERMO-MECHANICAL COIL WAS REMOVED FROM ITS PACKAGING, AND PRIOR TO USING THE PRODUCT, THE PHYSICIAN ATTEMPTED TO VERIFY IF THE COIL WOULD EXIT THE INTRODUCER, BUT THE COIL WOULD NOT EXIT THE INTRODUCER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DEPLOYING ANY COILS. THE PHYSICIAN FELT THAT THE BLOOD FLOW AT THE SITE OF THE ANEURYSM WAS TOO STRONG AND THAT THERE WAS A POSSIBILITY THAT THE COILS ¿WILL BE FLOWED AT THE MOMENT OF DETACHMENT¿. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE DEVICE WAS USED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE SALES REPRESENTATIVE ENVISAGED FROM THE PRODUCT AND SITUATION THAT THE COIL BECAME STUCK IN THE INTRODUCER ¿AT DIFFERENCE IN LEVEL¿. THE PHYSICIAN FURTHER STATED THAT THE COILS MIGHT BECOME STUCK AS THE FLOW OF THE VESSEL WAS SEVERELY TORTUOUS. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809099 ↗
• MalfunctionJun 28, 2018Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSFRAME10 (MFR100626/S13146) WAS USED DURING A POST-EVAR COIL EMBOLIZATION PROCEDURE OF A TYPE 2 ENDOLEAK ANEURYSM WHEN THE DELIVERY WIRE WAS BENT AND THE COIL COULD NOT BE ADVANCED. THE FEMORAL ARTERY WAS PUNCTURED BY 5FR SHEATH, THEN THE GUIDING CATHETER (5FR, IMAGER) AND THE MICROCATHETER (CORSAIR PV, ASAHI INTECC) WERE ADVANCED TO THE IMA. COIL EMBOLIZATION BEGAN AND A MICRUSFRAME18 WAS ATTEMPTED TO BE USED FOR THE THIRD COIL, BUT THE COIL INTRODUCER SPLIT AND THE COIL COULD NOT BE DELIVERED. THE COIL WAS REPLACED WITH ANOTHER ONE. AFTER APPROXIMATELY 4 COILS WERE USED, THE VESSEL DIAMETER HAD BECOME THINNER AND A MICRUSFRAME10 S WAS SELECTED. WHEN THE WIRE WAS ADVANCED INTO THE INTRODUCER, THE DELIVERY WIRE WAS BENT AND IT COULD NOT BE ADVANCED AT ALL. THE COIL WAS REPLACED WITH ANOTHER ONE. A DCB2 WERE ALSO USED FOR THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7647749 ↗
• MalfunctionMay 16, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ENDOVASCULAR AORTIC REPAIR (EVAR) AT THE INTERNAL ILIAC ARTERY, RESISTANCE WAS ENCOUNTERED WHEN THE 6 MM X 26 CM MICRUSFRAME10 THERMO-MECHANICAL COIL (MFR100626/S11575) WAS ADVANCED THROUGH THE INTRODUCER. THE COIL WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME10 FROM THE SAME LOT BUT THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS. AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER AND ENPOWER DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. THE COMPLAINT PRODUCTS WERE 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 DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN DID NOT APPLY FORCE IN AN ATTEMPT TO GET THE COIL TO EXIT THE INTRODUCER. THE PRODUCT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520579 ↗
• MalfunctionMay 16, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ENDOVASCULAR AORTIC REPAIR (EVAR) AT THE INTERNAL ILIAC ARTERY, RESISTANCE WAS ENCOUNTERED WHEN THE 6 MM X 26 CM MICRUSFRAME10 THERMO-MECHANICAL COIL (MFR100626/S11575) WAS ADVANCED THROUGH THE INTRODUCER. THE COIL WOULD NOT EXIT THE INTRODUCER. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME10 FROM THE SAME LOT BUT THE SAME ISSUE OCCURRED. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS NEITHER CALCIFIED NOR TORTUOUS. AN EXCELSIOR SL-10 (STRYKER) MICROCATHETER AND ENPOWER DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. THE COMPLAINT PRODUCTS WERE 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 DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN DID NOT APPLY FORCE IN AN ATTEMPT TO GET THE COIL TO EXIT THE INTRODUCER. THE PRODUCT WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520573 ↗
• MalfunctionJan 19, 2018Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO MICRUSFRAME 10 COILS (MFR100626/C41675) WERE USED DURING AN ANEURYSM COILING PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) WHEN RESISTANCE WAS ENCOUNTERED. BOTH COILS WOULD NOT ADVANCE INTO THE MC EVEN THOUGH THEY WERE FLUSHED AS PER IFU. MULTIPLE OTHER COILS WERE USED IN CASE AND WORKED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT AND NO MEDICAL INTERVENTION REQUIRED. THE PATIENT¿S VESSEL WAS HIGHLY TORTUOUS. THERE WAS NO DAMAGE NOTED TO THE DEVICES PRIOR TO USE. THERE WERE NO KINKS OR BENDS NOTED TO THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DIFFICULTY WAS EXPERIENCED IN REMOVING THE DEVICES FROM THE PATIENT. THE EVENT RESULTED IN A PROCEDURAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS A (B)(6) FEMALE WHO HAD A HISTORY OF ANEURYSMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7205829 ↗
• MalfunctionJan 19, 2018Kinked; Kinked

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT TWO MICRUSFRAME 10 COILS (MFR100626/C41675) WERE USED DURING AN ANEURYSM COILING PROCEDURE IN THE INTERNAL CAROTID ARTERY (ICA) WHEN RESISTANCE WAS ENCOUNTERED. BOTH COILS WOULD NOT ADVANCE INTO THE MC EVEN THOUGH THEY WERE FLUSHED AS PER IFU. MULTIPLE OTHER COILS WERE USED IN CASE AND WORKED. THERE WAS NO PATIENT INJURY AS A RESULT OF THE EVENT AND NO MEDICAL INTERVENTION REQUIRED. THE PATIENT¿S VESSEL WAS HIGHLY TORTUOUS. THERE WAS NO DAMAGE NOTED TO THE DEVICES PRIOR TO USE. THERE WERE NO KINKS OR BENDS NOTED TO THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DIFFICULTY WAS EXPERIENCED IN REMOVING THE DEVICES FROM THE PATIENT. THE EVENT RESULTED IN A PROCEDURAL DELAY OF LESS THAN 30 MINUTES. THE PATIENT WAS A (B)(6) FEMALE WHO HAD A HISTORY OF ANEURYSMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7205774 ↗
• MalfunctionDec 21, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, TWO MICRUSFRAME10 COILS ( MFR100626/S13305) COULD NOT PASS THROUGH THE HEADWAY MICROCATHETER, AND DURING PRODUCT ANALYSIS, IT WAS DISCOVERED THAT ONE OF THE COILS WAS KINKED. THE MICRUSFRAME COILS WERE INSERTED IN THE MICROCATHETER; HOWEVER, THE MICROCOILS DID NOT COME OUT FROM THE DISTAL TIP OF THE MICROCATHETER. THEREFORE, THEY WERE REMOVED FROM THE PATIENT AND IT WAS LATER CONFIRMED THAT THE MICROCOIL DID NOT COME OUT FROM THE DISTAL TIP OF THE MICROCATHETER OUTSIDE THE PATIENT EITHER. THE MICROCATHETER DID NOT APPEAR DAMAGED AND THE DEVICES WERE PREPPED AND USED AS PER THE IFU. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED; HOWEVER, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE 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 VESS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7138198 ↗