MICRUSFRAME MFR180830Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886704078210), received between Jan 5, 2018 and Mar 19, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Premature Separation” (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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2026Retraction Problem; Stretched; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING TWO BRONCHIAL ARTERY ANEURYSM, THE DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). AN APPROACH WAS MADE TO THE BRONCHIAL ARTERY USING A 5 FR ANGIOGRAPHIC CATHETER AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC). AFTER THE SYSTEM REACHED THE TARGET LESION, THE OUTFLOW TRACT OF THE ANEURYSM WAS EMBOLIZED WITH PUSHABLE COILS, THE EMBOLIZATION OF THE ANEURYSM ITSELF WAS INITIATED. AFTER IMPLANTING TWO 7 MM GALAXY G3 COILS, THE 6MM X 20CM GALAXY G3 (GLY120620 / 1682522S) WAS USED. IT WAS REPORTED THAT WHILE INSERTING THE GALAXY G3 COIL INTO THE MICROCATHETER, THE ANGIOGRAPHIC CATHETER DISLODGED FROM THE BRONCHIAL ARTERY. DURING THE ATTEMPT TO RESHEATH THE GALAXY G3 COIL IN ORDER TO RE-ENGAGE THE ANGIOGRAPHIC CATHETER, THE SHEATH BECAME MISALIGNED AND THE GALAXY G3 COULD NO LONGER BE REUSED. THE GALAXY G3 WAS REPLACED WITH NEW COIL. TWO ADDITIONAL COILS WERE PLACED, COMPLETING THE EMBOLIZATION OF THE FIRST BRONCHIAL ARTERY ANEURYSM. THE PROCEDURE THEN PROCEEDED TO THE SECOND ANEURYSM. THE 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 2612528S) WAS THE FIRST COIL USED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646186 ↗
• MalfunctionDec 22, 2025Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY IN TREATING AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE REPORTEDLY USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY WAS PERFORMED USING A 4F ANGIOGRAPHIC CATHETER (MEDICOS HIRATA); AFTER APPROACHING THE INTERNAL ILIAC ARTERY, THE 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 0972519S) WAS USED AS AN ANCHOR. THE FOLLOWING WAS REPORTED, ¿AFTER CONFIRMING THAT THE COIL HAD BEEN WOUND WITHOUT PROBLEMS, [AN ATTEMPT] TO DETACH [WAS MADE], BUT [IT COULD NOT].¿ SEVERAL ATTEMPTS WERE MADE, AND EVEN THOUGH THE POWER INDICATOR ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD, THE COIL DID NOT DETACH. THE COIL WAS REPLACED WITH ANOTHER 8MM X 30CM MICRUSFRAME 18 (MFR180830) AND THE REPLACEMENT COIL DETACHED WITHOUT NEEDING TO REPLACE THE CABLE OR THE BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTINUOUS FLUSH WAS MAINTAINED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865841 ↗
• MalfunctionApr 26, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED BASILAR TIP ANEURYSM USING A PULSE RIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD), THE PROWLER SELECT PLUS MICROCATHETER WAS INSERTED INTO A 6F DIRECT ACCESS CATHETER AND THE PULSERIDER ANRD WAS IMPLANTED VIA THE PROWLER SELECT PLUS MICROCATHETER. AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS INSERTED INTO THE 6F DIRECT ACCESS CATHETER AND APPROACHED THE TARGET ANEURYSM VIA TRANS CELL. AFTER TWO 10MM X 34CM MICRUS FRAME 18 COILS (MFR181034) WERE IMPLANTED, THE COMPLAINT COIL, AN 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 31168415) WAS USED AS THE THIRD COIL. IT WAS INSERTED INTO THE MICROCATHETER TO ABOUT 20CM ¿ 30CM WHEN RESISTANCE WAS FELT. THE PHYSICIAN PULLED THE 8MM X 30CM MICRUSFRAME 18 SLOWLY, AND THE COIL BECAME DETACHED AND REMAINED IN THE HUB OF THE MICROCATHETER. THE REMAINDER OF THE COIL WAS RETRIEVED BY HAND. IT WAS REPLACED WITH ANOTHER 8MM X 30CM MICRUSFRAME 18 (MFR180830) FROM A DIFFERENT LOT NUMBER. SUBSEQUENTLY SIX (6) CERENOVUS COILS AND SEVEN (7) COMPETITOR COILS WERE IMPLANTED. A TOTAL OF 16 COILS WERE IMPLANTED AND THE PROCEDURE WAS SUCCESSFUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195545 ↗
• MalfunctionJun 5, 2023Premature Separation; Premature Separation

  AS REPORTED BY THE FIELD, A MICRUSFRAME18 8MM X 30CM COIL (MFR180830, 30715082) BROKE OFF IN AN UNSPECIFIED MICROCATHETER (MC) WHEN RESHEATHING. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE WAS REPLACED WITH A NEW COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058005 ↗
• MalfunctionJan 30, 2023Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY FOR AN ENDOVASCULAR ANEURYSM REPAIR (EVAR), A CARRY LEON) MICROCATHERET (MC) WAS FLUSHED AND A MICRUSFRAME18 8MM X 30CM COIL (MFR180830, 30715083) WAS INSERTED INTO THE MICROCATHETER AND ADVANCED. AT THAT TIME, THERE WAS AN INTENSIVE RESISTANCE FELT, THEREFORE, THE COMPLAINT COIL WAS RE-SHEATHED. THE PHYSICIAN NOTICED THAT THE COMPLAINT COIL CAME OUT OF THE MICROCATHETER, BUT THE COIL WAS DETACHED FROM THE WIRE. THE PHYSICIAN SUSPECTED THAT THE MICROCATHETER WAS DAMAGED, THEREFORE, THE COMPLAINT COIL AND THE MICROCATHETER WERE REPLACED WITH OTHER DEVICES. THE PROCEDURE WAS COMPLETED AND THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE. THE LESION WAS THE LEFT INTERNAL ILIAC BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264036 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT (B)(6)), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, (B)(4)), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, (B)(4)), GALAXY G3 XSFT 4MM X 10CM (GLX120410, (B)(4)), MICRUSFRAME14 12MM X 30CM (MFR141230, (B)(4)), GALAXY G3 XSFT 3MM X 6CM (GLX120306, (B)(4)), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.5MM

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987088 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 53-YEAR-OLD MALE FEMALE PATIENT (SUBJECT 01208-010), UNDERWENT COIL EMBOLIZATION OF A RUPTURED RIGHT ANTERIOR CIRCULATION ANEURYSM AT THE POSTERIOR COMMUNICATING ARTERY ON (B)(6) 2021. IMMEDIATE MODIFIED RANKING SCALE (MRS) SCORE WAS 0 AND HUNT & HESS GRADE 3- DROWSINESS/CONFUSION, MILD FOCAL NEUROLOGIC DEFICIT. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 12.8MM, DOME 11.1MM, MAXIMUM ANEURYSM DIAMETER 12.8MM, NECK SIZE 3.8MM, AND THE DOME-TO-NECK RATIO OF 2.9MM. THE PARENT VESSEL DIAMETER WAS 3.7MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING SIXTEEN (16) CERENOVUS COILS: GALAXY G3 XTRASOFT 2MM X 8CM (GLX120208, 30485189), TWO MICRUSFRAME18 8MM X 30CM (MFR180830,30593195), MICRUSFRAME18 6MM X 12.2CM (MFR180612, L16774), MICRUSFRAME10 5MM X 17CM (MFR100517,30593189), MICRUSFRAME18 6MM X 12.2CM (MFR180612, K10010), GALAXY G3 XSFT 4MM X 10CM (GLX120410, K10380), MICRUSFRAME14 12MM X 30CM (MFR141230, L15281), GALAXY G3 XSFT 3MM X 6CM (GLX120306, L16504), GALAXY G3 XSFT 4MM X 10CM (GLX120410, 30571101), GALAXY G3 XSFT 3MM X 8CM (GLX120308, 30513169), GALAXY G3 XSFT 2.

  Patient problems: Aneurysm; Thromboembolism

  MAUDE report 15987053 ↗
• MalfunctionMay 16, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED BY THE FIELD, THE PHYSICIAN COULD NOT REMOVE THE MICRUSFRAME18 8MM X 30CM (MFR180830, L15892) WITHOUT DAMAGING. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO DAMAGES WERE OBSERVED ON THE SHIPPING BOX, OUTER PRODUCT BOX, NOR THE POUCH. THE INTEGRITY OF THE STERILE POUCH WAS NOT COMPROMISED, THE INNER STERILE BARRIER WAS NOT BREACHED. THE SEAL OF THE INNER POUCH WAS NOT OPEN UPON RECEIPT OF THE PRODUCT. THE PRODUCT HAD NOT BEEN PURPOSELY OPENED IN ANTICIPATION OF USE NOR HAD BEEN RE-SHELVED. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407140 ↗
• MalfunctionMar 14, 2022Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A RENAL ARTERY ANEURYSM, A LOGOS BALLOON CATHETER AND AN UNSPECIFIED COILING SUPPORT MICROCATHETER (MC) WERE USED. THE COMPLAINT COIL, A 8MMX30CM MICRUSFRAME COIL (MFR180830, 30393168) WAS USED AS FIRST COIL. IT WAS INSERTED INTO THE MICROCATHETER AS IT WAS PRESSED AGAINST THE HUB OF THE MICROCATHETER, BUT THERE WAS A RESISTANCE FELT BEFORE IT CAME OUT INSIDE BLOOD VESSEL. IT WAS RE-SHEATHED BUT THE COIL PART GOT PREMATURELY DETACHED IN A CONCOMITANT MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH ANOTHER ONE (COILING SUPPORT) AND A MICRUSFRAME COIL (MFRS180830, UNKNOWN LOT) WAS USED AS SECOND COIL WITHOUT ANY PROBLEMS. AFTER THAT, THE PROCEDURE COMPLETED WITH ANOTHER DIFFERENT SIZED TARGETXL COIL(S). THERE WAS NO PATIENT INJURY REPORTED. A CONTINUOUS FLUSH WAS DONE. CONCOMITANT DEVICES WERE A SHEATH INTRODUCER (5FR25 SUPER SHEATH), A GUIDING CATHETER (5FR65 SHEPHERD HOOK HANACO FOR ANGIO CATHETER) AND ENPOWER DETACHABLE CONTROL BOX (DCB2000500). ADDITIONAL INFORMATION RECEIVED INDICTED THAT THERE WAS NO REPORT THAT THE DEVICE APPEARED DAMAGED. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757513 ↗
• InjuryFeb 7, 2022Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY (IIA) ANEURYSM, THE FIRST AND SECOND FRAME S COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET LESION. THE COMPLAINT COIL, AN 8MM X 30CM MICRUSFRAME 18 (MFR180830 / 30649225) WAS POSITIONED IN THE ANEURYSM AS THE THIRD FRAMING COIL, BUT THE COIL FAILED TO DETACH. THE PHYSICIAN PRESSED THE DETACH BUTTON ON THE CONTROL CABLE AND THE BUZZER SOUNDED. USING FLUOROSCOPIC GUIDANCE, THE PHYSICIAN PULLED THE DEVICE POSITIONING UNIT (DPU) WIRE TO VERIFY COIL DETACHMENT. IT WAS RECOGNIZED THAT THE COIL-TAIL WAS IN A STATE WHERE IT WAS NOT ABLE TO BE PULLED TOGETHER WITH THE WIRE, AND IT WAS NOT ABLE TO BE DETACHED. THE COIL WAS PULLED BACK TO SOME EXTENT, AND THE COIL THEN DETACHED. THE COIL REMAINED INSIDE THE CONCOMITANT PROWLER SELECT PLUS MICROCATHETER (UNKNOWN PRODUCT CODE AND LOT NUMBER). WITH THE DPU WIRE, THE COIL WAS PUSHED OUT OF THE MICROCATHETER AND SOMEHOW IMPLANTED AT THE TARGET ANEURYSM. THE PROCEDURE PROGRESSED, AND THE STENT GRAFT WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13474124 ↗
• MalfunctionJan 4, 2022Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A BRAIN ANEURYSM, A MICRUSFRAME18 8MM X 30CM COIL (MFR180830, 30532734) WAS USED AFTER MICROCATHETER INDUCTION. THE PHYSICIAN ATTEMPTED TO ADJUST THE POSITION OF THE UNSPECIFIED MICROCATHETER. THEREFORE, THE COMPLAINT COIL WAS RE-SHEATHED, AND ATTEMPTED TO BE DELIVERED AGAIN, HOWEVER, AS THE DELIVERY WIRE BECAME DIFFICULT TO PUSH, THE USE WAS DISCONTINUED. IT WAS REPLACED WITH ANOTHER DIFFERENT PRODUCT AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THEY WERE ABLE TO REMOVE THE DEVICE THROUGH THE MICROCATHETER. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153572 ↗
• MalfunctionDec 16, 2021Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM GALAXY G3 COIL (GLY120515 / 30558382) WAS USED; IT WAS RESHEATHED AS PER THE INSTRUCTIONS FOR USE (IFU) BECAUSE ITS SIZE DID NOT FIT THE TARGET LESION. HOWEVER, THE INTRODUCER SHEATH BECAME DAMAGED AND IT COULD NOT BE RESHEATHED. IT WAS REPLACED WITH A 7MM X 21CM GALAXY G3 COIL (GLY120721 / 30530861), BUT IT WAS REPORTED THAT THIS COIL ¿FLEW¿ INTO THE BLOODSTREAM. IT WAS RESHEATHED AS PER THE IFU, BUT THE SHEATH ALSO BECAME DAMAGED AND THE COIL COULD NOT BE RESHEATHED. IT WAS THEN REPLACED WITH THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / 30399412). THIS COIL WAS IMPLANTED BUT IT WAS UNABLE TO BE DETACHED WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 30624693). THE DELIVERY WIRE WAS RETRACTED AND ¿AS IT WAS CUT¿ THEREFORE THE CATHETER KICKED BACK. IT WAS REPORTED THAT COIL EMBOLIZATION WAS STOPPED AND STENT GRAFT INSERTION WAS STARTED. IT WAS REPORTED THAT THE PRODUCTS ARE NOT AVAILABLE TO BE RETURNED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. ON 13 DEC 2021, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PROCEDURE WAS COMPLETED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13020681 ↗
• MalfunctionAug 12, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN APPROXIMATELY 10-12MM ANEURYSM ON THE INTERNAL CAROTID ARTERY, AFTER THE SUCCESSFUL IMPLANTATION OF FOUR (4) COILS: TWO (2) 10MM X 34CM MICRUSFRAME 18 COILS (MFR181034) AND TWO (2) 9MM X 33CM MICRUSFRAME 18 COILS (MFR180933), THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / L15892) WAS INSERTED AS THE FIFTH COIL USING THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER). AFTER ACTIVATION OF THE DETACHMENT CONTROL BOX (DCB), IT WAS REPORTED THAT THE RED SYSTEM FAULT LIGHT ILLUMINATED AND THE COIL DID NOT REACT TO THE DETACHMENT ATTEMPT. THE CONTROL CABLE WAS ALSO EXCHANGED ALONG WITH THE DCB, BUT THE SAME ERROR (RED SYSTEM FAULT LIGHT) WAS ILLUMINATED AGAIN. THE COMPLAINT COIL WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL WITHOUT ANY ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 03 AUGUST 2021. THE INFORMATION INDICATED THAT THE 8MM X 30CM MICRUSFRAME 18 COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT; IT WAS NOT STRETCHED WHEN IT WAS REMOVED. THE COIL WAS STILL ATTACHED TO THE DELIV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12316836 ↗
• MalfunctionDec 31, 2020Stretched; Difficult to Advance; Premature Separation; Stretched; Difficult to Advance; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM LOCATED ON THE MIDDLE CEREBRAL ARTERY (MCA), THE HEADWAY® 17 MICROCATHETER (MICROVENTION-TERUMO) WAS DELIVERED TO THE TARGET LESION AND THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / L17243) WAS USED AS THE FRAMING COIL, BUT IT DID NOT FIT THE LESION. THE PHYSICIAN REWINDED THE COIL SEVERAL TIMES BUT THERE WAS AN INTENSE RESISTANCE FELT. ADDITIONAL INFORMATION INDICATED THAT CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME PREMATURELY DETACHED IN THE MICROCATHETER. THE COMPLAINT COIL WAS REMOVED WITH THE MICROCATHETER. IT WAS CONFIRMED THAT THE COIL WAS UNRAVELED AND ¿CUT.¿ NO INFORMATION IS AVAILABLE REGARDING THE WHETHER THE ¿CUT¿ MEANT THE COIL PREMATURELY DETACHED OR IT WAS SEPARATED. NO INTERVENTION WAS REQUIRED. THERE WAS NO BLOOD FLOW RESTRICTION / REDUCTION AS A RESULT OF THE REPORTED EVENT; THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER MICROCATHETER AND ANOTHER COMPETITOR COIL WAS USED, AND THE FRAME WAS MADE. THE PROCEDURE WAS COMPLETED. THERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101973 ↗
• MalfunctionOct 20, 2020Material Twisted/Bent; Premature Separation; Material Twisted/Bent; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION WITH THE TARGET BEING A LEFT PULMONARY ARTERIOVENOUS FISTULA, A 5F SILICONE BALLOON CATHETER, A CARRY LEÓN HF MICROCATHETER (UTM), A CARRY LEÓN MICROCATHETER (UTM) WERE USED FOR FRAMING PURPOSES ON THE SAC PART OF THE PULMONARY ARTERIOVENOUS MALFORMATION (PAVM). THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR180830 / K10011) WAS INSERTED INTO THE CARRY LEÓN MICROCATHETER. THE DELIVERY WIRE WAS ADVANCED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), BUT THERE WAS AN INTENSE RESISTANCE FELT WHEN HALF OF THE SYSTEM ADVANCED. THE DELIVERY WIRE WAS RETRACTED, BUT THE COIL WAS NOT ABLE TO BE INSERTED INTO THE INTRODUCER. THE INTRODUCER SHEATH WAS REMOVED FROM THE HUB OF THE MICROCATHETER AND THE COIL PART WAS OBSERVED ALREADY DETACHED FROM THE DELIVERY WIRE. THE COMPLAINT COIL WAS REMOVED BECAUSE THE EXPOSED PART OF THE HUB WAS CAUGHT. IT WAS REPLACED WITH ANOTHER COIL, WAS INSERTED INTO THE MICROCATHETER, AND DELIVERED WITHOUT ANY PROBLEM. THE PROCEDURE RESUMED AND THE FOLLOWING COILS WERE USED TO EMBOLIZED THE SAC: 7MM X 21CM GALAXY G3 (GLY120721), 8MM X 24CM GALAXY G3 (GLY120824). THE MAIN ARTERIAL TRUNK IN FRONT OF TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10708621 ↗
• MalfunctionAug 5, 2020Stretched; Separation Failure; Premature Separation; Stretched; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH THE TARGET LESION AT THE INTERNAL ILIAC ARTERY, THE 8MM X 30CM MICRUSFRAME 18 COIL (MFR 180830 / L15892) WAS THE FIRST COIL TO BE DELIVERED TO THE TARGET LESION. THE GREEN SYSTEM READY LIGHT ON THE EMPOWER CONTROL CABLE (ECB00018200 / 30367115) ILLUMINATED BUT THE COIL COULD NOT BE DETACHED EVEN THOUGH THE DETACHMENT BUTTON WAS PRESSED MANY TIMES. THE GREEN SYSTEM READY LIGHT ILLUMINATED, AND ALL THE CONNECTIONS FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND WAS REPLACED WITH ANOTHER COIL (COMPETITOR PRODUCT) AND THE PROCEDURE WAS COMPLETED. THE REPORTED ISSUE DID NOT RESULT IN ANY PROLONGATION OR PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10368379 ↗
• MalfunctionDec 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A ENDOVASCULAR ANEURYSM REPAIR (EVAR) OF AN INTERNAL ILIAC ARTERY, THERE WAS STRONG RESISTANCE FELT BETWEEN THE DISTAL END OF A 8MM X 30CM MICRUSFRAME18 (MFR180830, S14023) AND A 8MM X 35CM DELTAFILL18 (DLF180835, S13515) WITH A COILING SUPPORT MICROCATHETER (MC). THE COMPLAINT COILS WERE NOT ABLE TO BE DELIVERED TO THE LESION. THE PHYSICIAN FLUSHED INSIDE THE MICROCATHETER AND THE DISTAL END OF THE COILS BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COILS WERE REPLACED WITH ANOTHER COIL (SAME CATALOG NUMBER) AND THE PROCEDURE WAS COMPLETED. SEVEN COILS WERE USED. PICTURES WERE RECEIVED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PICTURED WERE RECEIVED OF THE DEVICES. BASED ON THE ANALYSIS OF THE 8MM X 30CM MICRUSFRAME18 COIL, THE DEVICE WAS RETURNED WITHOUT THE EMBOLIC COIL. VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THAT THE RH COIL HAD NOT BEEN HEATED; THEREFORE, THE EMBOLIC COIL HAD MECHANICALLY DETACHED FROM THE DEVICE POSITIONING UNIT (DPU). ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT WHILE ADVANCING THE COIL DELIVERY SYSTEMS THROUGH THE CONCOMITANT MICROCATHETER, THE COIL PREMATURELY DETACHED ON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9473321 ↗
• MalfunctionSep 11, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A STENT-ASSISTED COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM, AN ATLAS STENT WAS PLACED FROM THE LEFT SIDE AND AN 11MM X 37CM MICRUSFRAME18 COIL WAS THEN FULLY DEPLOYED INTO THE ANEURYSM SAC, BUT THE COIL MASS PARTIALLY HERNIATED INTO THE PARENT VESSEL. ADDITIONAL 6F ACCESS WAS OBTAINED AT THE RIGHT FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO PASS A MICROCATHETER FROM THE RIGHT INTERNAL CAROTID ARTERY (ICA) TO THE OPPOSITE ANTERIOR CEREBRAL ARTERY (ACA) VESSEL TO PLACE A SECOND ATLAS STENT, BUT THE COIL MASS WAS IN THE PATH OF THE MICROCATHETER. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE COIL TO PLACE THE STENT ACROSS THE OPPOSITE ACA, BUT THE COIL COULD NOT BE PULLED BACK INTO THE SL-10 (STRYKER) MICROCATHETER BECAUSE IT HAD PREMATURELY DETACHED IN THE MICROCATHETER. THE PHYSICIAN HAD PLANNED ON DETACHING THE COIL AFTER DEPLOYING THE SECOND ATLAS STENT, BUT HE WAS UNABLE TO ADVANCE THE MICROCATHETER PAST THE COIL MASS INTO THE OTHER A1 BRANCH. THE COIL WAS LEFT PARTIALLY PROTRUDING FROM THE ANEURYSM INTO THE PARENT ARTERY, RESULTING IN LEFT A2 CLOT FORMATION. THE CLOT WAS TREATED WITH INTEGRILIN AND 2MG OF T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8992460 ↗
• MalfunctionAug 27, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED ON THE 9MM X 15.3CM MICRUSFRAME 18 COIL (MFR180830 / L14779), BUT THE GREEN SYSTEM READY LIGHT ON THE DETACHMENT CONTROL BOX DID NOT ILLUMINATE. THE COIL WAS REPLACED WITH ANOTHER MICRUSFRAME 18 COIL OF THE SAME SIZE AND FROM THE SAME LOT NUMBER. THE DETACHMENT CONTROL BOX WAS POWERED OFF AND BACK ON AGAIN BEFORE ANOTHER PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITHOUT ANY ISSUE. THE REPLACEMENT COIL WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION DUE TO THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8936509 ↗
• MalfunctionJul 17, 2019Migration or Expulsion of Device; Difficult to Remove; Unraveled Material; Migration or Expulsion of Device; Difficult to Remove; Unraveled Material

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE USER WANTED TO WITHDRAW THE 8MMX30CM MICRUSFRAME 18 COIL (MFR180830, L13636) FROM THE ANEURYSM, BACK INTO A SL10 MICROCATHETER (MC), HOWEVER, THE COIL SEEMED STUCK. AFTER SOME MANIPULATION IT BECAME APPARENT THAT THAT THE COIL¿S RESISTANT MATERIAL HAD STRETCHED AND THE COIL PROTRUDED INTO PATIENT ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800066 ↗
• MalfunctionMar 27, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE SPLENIC ARTERY, A 9 MM MICRUSFRAME COIL WAS SELECTED AND IMPLANTED AS A FRAME. THE 8MM X 30CM MICRUSFRAME COIL (MFR180830/ L13636) WAS THE DELIVERED TO THE TARGET LESION AND THE DETACHMENT BUTTON ON THE ENPOWER CONTROL CABLE (ECB000182-00 / L14647) WAS PRESSED BUT THE COIL DID NOT DETACH. THE CONTROL CABLE WAS REMOVED AND RECONNECTED, THE MICROCATHETER WAS MOVED BUT THE COIL STILL COULD NOT BE DETACHED. THE DETACHMENT CONTROL BOX (DCB2) WAS REPLACED BUT THE ISSUE WITH THE COIL DETACHMENT WAS NOT RESOLVED. THE 8MM X 30CM MICRUSFRAME COIL WAS REPLACED WITH A NEW COIL OF THE SAME SIZE AND THE REPLACEMENT COIL DETACHED WITHOUT ANY INCIDENT OR DELAY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS 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 PRODUCTS ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8457404 ↗
• MalfunctionApr 12, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A GASTRODUODENAL ARTERY (GDA) ANEURYSM, THE 8 MM X 30 CM MICRUSFRAME18 (MFR180830/S14287) THERMO-MECHANICAL COIL COULD NOT BE PROPERLY PLACED IN THE TARGET SITE; THEREFORE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL. THE INTRODUCER WAS DELIVERED TO THE MICROCATHETER HUB. THE PHYSICIAN TRIED TO COVER THE DEVICE USING THE SLEEVE; HOWEVER, ¿ENGAGEMENT WAS BAD¿ AND RESISTANCE WAS ENCOUNTERED. FURTHERMORE, A PART OF THE SLEEVE BECAME DAMAGED WHEN IT WAS LOWERED. THE COIL WAS REPLACED WITH A COIL FROM THE SAME CATALOG NUMBER. THE PROCEDURE WAS COMPLETED WITH USING 9 COILS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). AN EXCELSIOR 1018 (STRYKER) MICRO CATHETER WAS APPROACHED TO THE BRANCH OF THE ANEURYSM AND THE MICRUSFRAME18 COIL WAS SELECTED FOR USE. THE COIL WAS PREPARED ACCORDING TO IFU AND COIL EMBOLIZATION WAS INITIATED. A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAG

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7424584 ↗
• MalfunctionJan 5, 2018Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING ENDOVASCULAR ANEURYSM REPAIR (EVAR) AT THE LEFT INTERNAL ILIAC ARTERY, AN 8 MM X 30 CM MICRUSFRAME18 ((B)(4)) THERMO-MECHANICAL COIL WAS SELECTED AS THE THIRD COIL TO BE PLACED; HOWEVER, THE GREEN SYSTEM READY LIGHT WAS NOT CONFIRMED ON THE DETACHMENT CONTROL BOX. THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THIS EVENT. THE PATIENT¿S VESSEL WAS HEAVILY TORTUOUS AND MODERATELY CALCIFIED. A DCB02 DETACHMENT CONTROL BOX, A PROWLER SELECT PLUS 45 MICROCATHETER, AND AN ENPOWER CONTROL CABLE WERE USED FOR THE CASE. THE PRODUCTS WERE REPORTEDLY NOT FLUSHED DURING THE PROCEDURE. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). 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 MICROCATHETER. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170002 ↗