MICRUSFRAME MFR181034Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704077213), received between Nov 3, 2017 and Mar 18, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING THE INTERNAL ILIAC ARTERY PERFORMED DURING STENT GRAFT IMPLANTATION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DEVICES WERE USED ACCORDING TO THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). EMBOLIZATION OF THE INTERNAL ILIAC ARTERY WAS CONDUCTED USING A SYSTEM CONSISTING OF A 4 FR ANGIOGRAPHIC CATHETER AND THE COIL SUPPORT (MEDICOS HIRATA). THE 10MM X 34CM MICRUSFRAME 18 (MFR181034 / 2232569S) WAS USED AS THE FIRST COIL, SERVED AS AN ANCHOR FOR THE SUPERIOR GLUTEAL ARTERY. AFTER COILING AT THE TARGET SITE, DETACHMENT OF THE 10MM X 34CM MICRUSFRAME 18 COIL WAS ATTEMPTED, BUT THE COIL COULD NOT BE DETACHED. THE COIL WAS REPLACED WITH ANOTHER COIL OF THE SAME SPECIFICATION. THE REPLACEMENT COIL WAS SUCCESSFULLY DETACHED, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED. NO INDICATOR LIGHTS ON THE CONTROLLER BOX ILLUMINATED TO INDICATE ANY ABNORMALITY. THE REPORTED ISSUE DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THERE WAS NO NEGAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634810 ↗
• MalfunctionJul 24, 2023Difficult to Advance; Positioning Problem; Difficult to Advance; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TARGETING A RENAL ARTERY ANEURYSM THAT STARTED WITH BALLOON-ASSISTED DOUBLE CATHETER TECHNIQUE USING A TRANSFORM® BALLOON CATHETER (STRYKER), FRAMING WITH A 12MM MICRUSFRAME S COIL WAS PERFORMED AND THE SECOND MICROCATHETER WAS INSERTED, AND A 10MM MICRUSFRAME COIL WAS IMPLANTED. AFTER THAT, ANOTHER MICRUSFRAME COIL, A 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / 30704833) WAS INSERTED, BUT THERE WAS RESISTANCE DURING THE COIL INSERTION INTO THE MICROCATHETER, AND ¿AN ABNORMAL BEHAVIOR DURING COIL EMBOLIZATION INTO THE ANEURYSM WERE FOUND, SO THE COIL WAS RETRIEVED.¿ IT WAS REPORTED THAT ANOTHER 10MM MICRUSFRAME COIL WAS PLANNED TO BE INSERTED TO CONTINUE WITH THE PROCEDURE, BUT DUE TO A SHORTAGE OF PRODUCTS, THE PROCEDURE WAS CONTINUED AND COMPLETED USING COMPETITOR COILS. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. ON (B)(6)2023, PRE-SHIPMENT PHOTOS OF THE COMPLAINT DEVICE WERE ADDED TO THE COMPLAINT FILE. ON 07-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE ¿ABNORMAL BEHAVIOR DURING COIL EMBOLIZATION INTO THE ANEURYSM WERE FOUND¿ MEANT THAT THE COIL FA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17380577 ↗
• MalfunctionDec 15, 2021Stretched; Difficult to Advance; Stretched; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE RENAL ARTERY ANEURYSM, A MICRUSFRAME 18 10MM X 34CM COIL (MFR181034, L16838) WAS USED AS A FRAMING COIL FOR THE FIRST. AT THE TIME OF COIL PLACEMENT, AND THERE WAS A STRONG RESISTANCE FELT BETWEEN THE COMPLAINT PRODUCT AND THE UNSPECIFIED CATHETER AT THE PLACE WHERE THE COIL CAME OUT ABOUT 3 CM FROM THE CATHETER. THE COMPLAINT PRODUCT BECAME UNRAVELED. AFTER THAT, THE COMPLAINT PRODUCT WAS REMOVED, AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH OTHER COILS. THERE WAS NO HEALTH HAZARD TO THE PATIENT. IT WAS UNCLEAR IF A CONTINUOUS FLUSH WAS DONE. THE LESION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010672 ↗
• MalfunctionAug 31, 2021Fracture; Retraction Problem; Difficult to Advance; Fracture; Retraction Problem; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A TVER COIL EMBOLIZATION AT THE SUBCLAVIAN ARTERY ANEURYSM AFTER STENTING, AN UNSPECIFIED MICROCATHETER WAS DELIVERED TO THE LESION. A 12MM X 40CM MICRUSFRAME18 COIL (MFR181240, UNKNOWN LOT) WAS USED AS THE FIRST COIL AND THE COMPLAINT COIL, A 10MM X 34CM MICRUSFRAME18 (MFR181034, 30409566) WAS USED AS THE SECOND COIL. HOWEVER, THERE WAS A RESISTANCE FELT WHILE IT WAS BEING DELIVERED. THE PHYSICIAN ATTEMPTED TO GET THE WIRE BACK ONCE, BUT THE WIRE GOT TORN AND IT WAS IMPOSSIBLE TO IMPLANT THE COMPLAINT COIL. IT WAS REPLACED WITH ANOTHER COIL (SAME CATALOG NUMBER, DIFFERENT LOT NUMBER) AND IT WAS IMPLANTED. AFTER THAT, THREE COILS WERE IMPLANTED, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391385 ↗
• MalfunctionApr 28, 2021Migration; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRE-EVAR (ENDOVASCULAR ANEURYSM REPAIR) PROCEDURE TARGETING AN ANEURYSM AT THE LEFT INTERNAL ILIAC ARTERY, AN APPROACH WAS MADE FROM THE LEFT BRACHIAL ARTERY TOWARDS THE LEFT INTERNAL ILIAC ARTERY. AFTER FOUR COILS: A 4MM X 10CM GALAXY G3 XSFT COIL (GLX120410 / 30422331), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30401373), A 6MM X 20CM GALAXY G3 COIL (GLY120620 / 30399453), AND A 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / L13774) WERE IMPLANTED, ANOTHER 6MM X 20CM GALAXY G3 COIL (GLY120620 / UNKNOWN LOT) WAS CHOSEN BUT THE COIL WAS NOT ABLE TO GO INTO THE COIL MASS. THE PHYSICIAN ATTEMPTED TO RESHEATH IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). IN THE MEANTIME, THE COIL MASS WAS REPORTED TO HAVE THROMBOSED AND A CONCOMITANT LIGHTHOUSE MICROCATHETER (PIOLAX MEDICAL DEVICES) AND PART OF THE COIL MASS BECAME STUCK TOGETHER; THE COIL MASS DID NOT COME OFF EVEN WHEN THE WIRE WAS REMOVED AND FLUSHED. WHEN THE MICROCATHETER WAS PULLED BACK TO THE TIP OF THE CONTRAST CATHETER AND THE CONTRAST CATHETER WAS TORQUED, THE COIL MASS CAME OFF AND WENT BACK SETTLING AROUND THE ORIGINAL POSITION BY THE FLOW OF THE BLOOD. IT WAS THEN CONFI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740299 ↗
• MalfunctionApr 19, 2021Break; Break

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR PRE-STENT GRAFT AT THE INTERNAL ILIAC ARTERY, A 10MM X 34CM MICRUSFRAME18 COIL (MFR181034, L13474) WAS USED AS A SECOND COIL AFTER A PROWLER SELECT PLUS (PSP) MICROCATHETER WAS DELIVERED TO STARTING POINT OF THE LESION. IT WAS INSERTED INTO Y-CONNECTOR BUT THE WIRE BECAME BROKEN AND IT WAS NOT ABLE TO BE DELIVERED. IT WAS REPLACED WITH ANOTHER COIL (DIFFERENT LOT NUMBER) AND THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685253 ↗
• MalfunctionOct 22, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY, A 10MM X 34CM MICRUSFRAME18 COIL (MFR181034, MFR181034) WAS BEING USED AS THE SECOND COIL, BUT IT WAS NOT ABLE TO BE DETACHED. THE GREEN SYSTEM READY LIGHT ILLUMINATED DURING THE PRE-DETACHMENT ELECTRICAL CHECK, BUT THE LIGHT DURING DETACHMENT DID NOT ILLUMINATE. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (8MM) AND THE SAME DETACHMENT SYSTEM WAS USED TOGETHER. IT WAS DETACHED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY. THE SAME DCB AND CONNECTING CABLE WERE USED WITH SUBSEQUENT COILS. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. ADEQUATE FLUSH WAS MAINTAINED THROUGH THE DEVICES. THE EVENT DID NOT PROLONG THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717579 ↗
• MalfunctionJan 3, 2020Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE TREATMENT OF THE ANEURYSM, THE 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / LOT#: UNKNOWN) AND THE PUSHER BECAME SEPARATED DURING PLACEMENT. THERE WAS NO REPORT OF ANY PROCEDURAL DELAY. THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546104 ↗
• MalfunctionJan 3, 2020Unraveled Material; Premature Separation; Unraveled Material; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM AT THE SPLENIC ARTERY, A 10MM X 34CM MICRUSFRAME18 COIL (MFR181034, S13067) WAS INSERTED AND IT WAS RE-WINDED TWICE OR THREE TIMES. IT WAS RE-SHEATHED TO CHANGE THE POSITION OF THE CONCOMITANT MICROCATHETER (CARRY REON). HOWEVER, IT WAS PREMATURELY DETACHED, AND THE DELIVERY WIRE ONLY WAS RETRACTED. THE UNRAVELED COIL WAS REMOVED WITH THE CONCOMITANT MICROCATHETER (CARRY REON). THE PROCEDURE COMPLETED BY USING ANOTHER GALAXY COIL (GLY120510). THE CONCOMITANT MICROCATHETER WAS FLUSHED EACH TIME. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9545116 ↗
• MalfunctionMay 15, 2019Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-STENT GRAFT COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE RIGHT INTERNAL ILIAC ARTERY, THE 10MM X 34CM MICRUSFRAME 18 COIL (MFR181034 / L13531) WAS CHOSEN AS THE FIRST ANCHOR COIL. THE MICROCATHETER (PIOLAX, LIGHTHOUSE) WAS FLUSHED FROM THE DISTAL END AND AN ATTEMPT WAS MADE TO INSERT THE COIL, BUT THE RESISTANCE WAS FELT, AND THE COIL INTRODUCER SHEATH SPLIT, AND IT WAS REPORTED THAT THE COIL WAS PROTRUDED FROM THE INTRODUCER. THERE WAS NO KINK OR BEND ON THE COIL, THE MICROCATHETER AND THE CONCOMITANT DEVICES PRIOR TO USE; THE COIL SHEATH INTRODUCER WAS CONFIRMED TO BE WITHOUT ANY DAMAGE PRIOR TO USE. ADEQUATE AND CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE 10MM X 34CM MICRUSFRAME 18 COIL WAS REPLACED WITH ANOTHER 10MM X 34CM MICRUSFRAME 18 COIL; THE REPLACEMENT COIL IMPLANTED WITHOUT ANY ISSUE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. IT WAS CONFIRMED THAT THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU), THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY, AND THE USER DID NOT APPLY EXCESSIVE FORCE DURING THE UNSHEATHING AND RESHEATHING OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612707 ↗
• MalfunctionMar 11, 2019Off-Label Use; Stretched; Material Deformation; Off-Label Use; Stretched; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM AT THE INTERNAL ILIAC ARTERY, THE 10MM X 34CM MICRUSFRAME18 (MFR181034/L10623) WAS SELECTED AS THE FIRST COIL, BUT THE SIZE DID NOT FIT IN THE ANEURYSM. THEREFORE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT RESISTANCE WAS ENCOUNTERED WHEN THE ZIPPER WAS SLID DOWN. THE PHYSICIAN THEN ZIPPED AND UNZIPPED, BUT THE INTRODUCER SHEATH BECAME DAMAGED AND THE DELIVERY WIRE PROTRUDED FROM THE SHEATH. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGICAL DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. IT WAS REPORTED THAT 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. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THERE WAS NO DIFFICULTY ENCOUNTERED UNSHEATHING THE INTRODUCER TUBE FROM THE DELIVERY TUBE OF THE DETACHABLE COIL DELIVERY SYSTEM. NO UNINTENDED DETACHMENT WAS OBSERVED I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409812 ↗
• MalfunctionFeb 11, 2019Migration; Component Misassembled; Migration; Component Misassembled

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CEREBRAL ARTERY ANEURYSM REPAIR PROCEDURE, THE SURGEON NOTED THAT THE MARKERS ON THE 10 MM X 34 CM MICRUSFRAME 18 DETACHABLE COIL SYSTEM (MFR181034 / L10323) WERE OFFSET. WHEN THE PHYSICIAN DETACHED THE COIL AND PULLED THE DELIVERY SYSTEM, THE COIL PROTRUDED INTO THE PARENT VESSEL DESPITE BEING FULLY DETACHED. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE OR ADVERSE EVENT. THERE WAS NO REPORT OF ANY PROCEDURAL DELAY DUE TO THE REPORTED ISSUE. THE COIL REMAINS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8329687 ↗
• MalfunctionMay 18, 2018Kinked; Premature Activation; Stretched; Kinked; Premature Activation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM, TWO MICRUSFRAME18 (MFR181034/S13303 AND MFR181647/S13629) DEVICE POSITIONING UNIT (DPU) WIRES KINKED AS THEY WERE BEING PUSHED AND COULD NO LONGER BE ADVANCED. THE COIL DELIVERY SYSTEMS WERE REMOVED FROM THE MICROCATHETER AND REPLACED. THE COILS WERE ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS NOT CALCIFIED. THE PATIENT¿S LEVEL OF VESSEL TORTUOSITY IS UNKNOWN. A MASTERS PAKWAYSOFT (ASAHI INTECC) GUIDEWIRE, A MEISTER (MEDIKIT) GUIDEWIRE, A LEONIS MOVE (KAWASUMI LABORATORIES) MICROCATHETER, A VIRTUS (BOSTON SCIENTIFIC) MICROCATHETER, A Y-CONNECTOR, AND A DETACHMENT CONTROL BOX (DCB) WERE ALSO USED FOR THE CASE. THE 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. THE PRODUCTS WERE PREPPED ACCORDING TO THE IFU. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7525053 ↗
• MalfunctionApr 11, 2018Kinked; Failure to Advance; Physical Resistance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSFRAME 18 (MFR181034/S12917) WAS USED DURING A TYPE II ENDOLEAK PROOF COIL EMBOLIZATION PROCEDURE AT THE LEFT IIA PRIOR TO A SG PROCEDURE. AN APPROACH WAS TAKEN FROM THE RIGHT FEMORAL ARTERY TO THE TARGET VESSEL. THE ANGIO CATHETER, THE MICROCATHETER AND THE GUIDEWIRE WERE INSERTED. THE DIAMETER OF THE TARGET VESSEL WAS 6 TO 7 MM. THE FIRST COIL (8 MM*30 CM FRAMES) WAS PREPARED BY THE SECOND PHYSICIAN AND WAS INSERTED BY THE FIRST PHYSICIAN. THEN MORE COILS (DELTAFILL18 AND FRAMEC) WERE DELIVERED TO THE LESION AS WELL. THERE WAS A PARTIALLY WIDE PART IN THE LESION, SO THE COMPLAINT COIL WAS USED AS AN ANCHORING COIL. THE SECOND PHYSICIAN PREPARED IT AND THE FIRST PHYSICIAN INSERTED IT. HOWEVER THERE WAS RESISTANCE FELT IN THE SHEATH INTRODUCER AND THE COIL COULD NOT BE INSERTED TO THE MICROCATHETER. THEREFORE IT WAS REPLACED WITH A NEW COIL. ANGIOGRAPHY CONFIRMED THAT THE COILS WERE IMPLANTED AS PLANNED. THE PHYSICIAN COMMENTED THAT IT WAS POSSIBLE THAT THE SHEATH INTRODUCER HAS BEEN KINKED. THE COMPLAINT PRODUCT WAS NOT FLUSHED DURING THE PROCEDURE. THE PATIENT WAS A MALE BUT HIS AGE WAS UNKNOWN. THE PATIENT¿S VESSEL WAS MOD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422750 ↗
• MalfunctionNov 3, 2017Premature Activation; Physical Resistance; Premature Activation; Physical Resistance

  DURING COIL EMBOLIZATION OF AN ANEURYSM FOR EVER, A MICRUSFRAME 18 (MFR181034/ C42047) BECAME STUCK IN THE PROWLER SELECT PLUS (606S255FX/17136614) AND THE COIL DETACHED AND ANOTHER MICRUSFRAME 18 COIL (MFR181137/ S11770) ALSO BECAME STUCK IN THE MICROCATHETER. WHEN THE COIL EMBOLIZATION WAS PERFORMED AT THE SUPERIOR GLUTEAL ARTERY, THE COMPLAINT COIL (LOT C42047) WAS USED WITH THE COMPLAINT CATHETER (PROWLER SELECT PLUS) BUT IT GOT STUCK IN THE CATHETER. THE PHYSICIAN TRIED TO REMOVE THE COIL, BUT IT WAS DETACHED IN THE CATHETER. THEREFORE, THE COIL WAS REMOVED WITH THE CATHETER. THE COIL AND THE CATHETER WERE REPLACED WITH ANOTHER ONE. THEN THE NEXT MICRUSFRAME COIL (LOT S11770) WAS ATTEMPTED TO BE USED, BUT IT GOT STUCK IN THE MICROCATHETER AND WAS REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. . THE PATIENT WAS A MALE BUT HIS AGE WAS UNKNOWN. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS AND CALCIFICATION WERE UNKNOWN. NO REPORT OF THE OTHER DEVICE USED IN THE PROCEDURE IS AVAILABLE. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS C

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7001966 ↗