MICRUSFRAME MFR100829Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077909), received between Apr 19, 2017 and Sep 12, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Physical Resistance” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT A MICRUSFRAME10 8MM X 29CM (MFR100829/ 30762310) WAS USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED THE COIL WAS IMPEDED IN THE MICROCATHETER WITH NO LOSS OF CEREBRAL TARGET POSITION. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿WHEN THE FIRST COIL WAS FORTIFIED, THE MC COULD NOT BE INSERTED.¿ ON 13-AUG-2024, ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL. SUMMARY: PER THE INFORMATION, THE EVENT DATE/PROCEDURE DATE WAS (B)(6) 2024. IT WAS CONFIRMED THE REPORTED EVENT REFERS TO A COIL THAT COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE MICROCATHETER USED WAS AN EXCELSIOR SL-10 MICROCATHETER (STRYKER). REGARDING IF THE EVENT RESULTED IN ANY UNDUE PROCEDURAL DELAY OR CONSEQUENCE THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT, IT WAS STATED, ¿THE PATIENT UNDERWENT ANEURYSM EMBOLIZATION DUE TO A RUPTURED AND BLEEDING ANEURYSM. HOWEVER, CONTINUOUS COIL DEFECTS OCCURRED, CAUSING A DELAY OF APPROXIMATELY TEN MINUTES DURING THE REPLACEMENT PROCESS, WHICH MAY HAVE LED TO FURTHER BLEEDING.¿ REGARDING IF OTHER DEVICES WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER PRIOR TO OR AFTER THE ENCOUN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20202643 ↗
• InjuryAug 3, 2021Stretched; Premature Separation; Stretched; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION OF A RIGHT CEREBRAL ARTERY (UNSPECIFIED), AN 8MM X 29CM MICRUSFRAME10 (MFR100829/30399409) WAS SELECTED FOR USE AS THE FIRST COIL BUT BECAME STRETCHED AND PREMATURELY DETACHED FROM THE DELIVERY WIRE AT THE TIME OF REMOVAL. IT THE COIL WAS ULTIMATELY REMOVED FROM THE PATIENT USING SOLITAIRE (MEDTRONIC) STENT RETRIEVER AND SNARE DEVICE. THERE WAS NO REPORT OF PATIENT INJURY. HOWEVER, BECAUSE OF THE LONG DELAY, THE OPERATION HAD TO BE STOPPED AFTER THE COIL WAS RECOVERED. THE DEVICES REPORTEDLY FUNCTIONED AS INTENDED PRIOR TO THE PREMATURE DETACHMENT. THERE WAS AN ADEQUATE FLUSH MAINTAINED THROUGH THE DEVICES. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONALLY, A SINGLE PROCEDURAL IMAGE WAS PROVIDED ON 02-AUG-2021 AND WAS FORWARDED TO AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT/NEUROVASCULAR SURGEON FOR MEDICAL REVIEW. THE MEDICAL IMAGE ATTACHED TO THE COMPLAINT WAS REVIEWED BY AN INDEPENDENT MEDICAL AFFAIRS CONSULTANT, NEUROVASCULAR SURGEON ON 02-AUG-2021 THE ASSESSMENT READS AS FOLLOWS: ¿A COMPLAINT OF PREMATURE DETACHMENT OF A MICRUSFRAME10 8 MM X 29 CM IS SUBMI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267239 ↗
• InjuryJul 30, 2021Material Separation; Separation Failure; Material Separation; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COIL EMBOLIZATION PROCEDURE, IT WAS IMPOSSIBLE TO DETACH AN 8MM X 29CM MICRUSFRAME10 COIL (MFR100829 / L14995) WHICH WAS POSITIONED IN THE ANEURYSM. SEVERAL FAILED ATTEMPTS WERE MADE TO RELEASE AND CHANGE THE HANDLE, THE PHYSICIAN DECIDED TO REMOVE THE COIL. DURING RETRIEVAL, THE COIL BROKE AND WAS RELEASED ON ITS OWN LEAVING THE PROXIMAL PART OF THE COIL IN THE CIRCULATION. THE PATIENT SUBSEQUENTLY DEVELOPED AN ARTERIAL THROMBUS. ON 16 JULY 2021, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT RECEIVED ANTIPLATELET MEDICATION (I.E., ANTIAGGREGANT) AND SURVEILLANCE AS TREATMENT FOR THE REPORTED THROMBOTIC EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12256997 ↗
• MalfunctionNov 16, 2020Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING AN EMBOLIZATION OF INTRACRANIAL ANEURYSM, AN 8MM X 29CM MICRUSFRAME10 COIL (MFR100829, L11201) DID NOT DETACHED FROM THE GUIDE, AFTER MULTIPLE ATTEMPTS. HAVING MADE ATTEMPTS IN WHICH THE CABLE AND BATTERY WERE CHANGED. TO MANAGE THE PROBLEM DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE COIL FROM THE ANEURYSM SAC. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT PRE-DEPLOYMENT ELECTRICAL TESTING WAS PERFORMED, THE REPORTED FAILURE DID NOT OCCUR DURING TESTING. THE CATALOG AND LOT NUMBER FOR THE CONNECTING CABLE USED WITH THE COIL IS UNKNOWN. THE CONNECTING CABLE IS NOT AVAILABLE FOR ANALYSIS. THE SAME DCB WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. THE SECOND CONNECTING CABLE WAS USED SUCCESSFULLY WITH SUBSEQUENT COILS. WHEN THE MICRUSFRAME10 COIL WAS REMOVED FROM THE PATIENT, THE ACTUAL COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED BY USING ANOTHER COIL. THE EVENT PROLONGED THE PROCEDURE BY A FEW MINUTES, IT WAS NOT SIGNIFICANT. THERE WAS NO CALCIFICATION AT THE TARGETED VESSEL, THERE WAS NORMAL TORTUOSITY AND THE DIAMETER OF THE VESSEL WAS 4.5MM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843203 ↗
• MalfunctionMay 4, 2018Physical Resistance; Physical Resistance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE INTERNAL CAROTID ARTERY, THE PHYSICIANS INTRODUCED THE GALAXY G3 9 MM X 25 CM COIL (GLY120925 / L10569) THROUGH A MICROCATHETER (EXCELSIOR SL 10 STRYKER). THIS COIL FAILED TO DETACH AFTER SEVERAL ATTEMPTS WERE MADE BY THE PHYSICIANS TO DETACH IT. IT WAS REMOVED FROM THE PATIENT AND WAS DETERMINED TO HAVE A FAULTY CONNECTION TO THE DELIVERY SYSTEM. THE PHYSICIANS CHOSE ANOTHER COIL, A MICRUSFRAME10 8 MM X 29 CM (MRF100829 / L10132), THIS COIL WAS CHECKED AND DETERMINED TO HAVE NO ISSUE WITH BEING CONNECTED TO THE CABLE OR THE DETACHMENT BOXES. THE PHYSICIANS MADE SEVERAL ATTEMPTS TO INTRODUCE THE COIL TO THE SAME MICROCATHETER (EXCELSIOR SL 10, STRYKER) THAT WAS USED WITH THE GALAXY G3 COIL, BUT THE COIL COULD NOT BE INTRODUCED INTO THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE PATIENT AND ANOTHER ATTEMPT TO INTRODUCE THE COIL INTO THE MICROCATHETER WAS MADE OUTSIDE OF THE PATIENT¿S BODY WITH SALINE FLUSH. THE COIL WAS ABLE TO ADVANCE THROUGH THE MICROCATHETER BUT WITH DIFFICULTY AND RESISTANCE. THE PHYSICIANS USED TWO TARGET COILS (STRYKER) AND ONE COIL (DERIVO)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488881 ↗
• InjuryApr 19, 2017Fracture; Stretched; Physical Resistance; Fracture; Stretched; Physical Resistance

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT RESISTANCE WAS EXPERIENCED WHEN A MICRUSFRAME COIL WAS USED AND THE COIL SEPARATED IN PATIENT. THE PROCEDURE WAS STENT-ASSISTED COIL EMBOLIZATION FOR TREATMENT OF AN 9 MM INTERNAL CAROTID ARTERY ANEURYSM. THE PATIENT HAD VERY TORTUOUS VESSELS. A 3 MM ENTERPRISE STENT (LOT UNKNOWN) WAS PLACED ACROSS THE NECK OF THE ANEURYSM. THE PHYSICIAN THEN TRIED TO ADVANCE A PROWLER LPES 150 CM, HOWEVER DUE TO TORTUOSITY THE CATHETER WOULD NOT CROSS THE STENT INTO THE ANEURYSM. IT WAS THEN DECIDED TO USE A PROWLER14 170 CM CATHETER WHICH SUCCESSFULLY ENTERED THE ANEURYSM. THEN A MICRUSFRAME 8 X 29 CM COIL WAS USED WHICH WAS DEPLOYING WELL UNTIL IT WAS HUBBED. THE COIL WAS PARTIALLY DEPLOYED IN THE ANEURYSM WHEN THE COIL COULD NOT BE ADVANCED ANY FURTHER, 3 CM WAS LEFT INSIDE THE CATHETER. WHEN AN ATTEMPT WAS MADE TO REMOVE THE COIL, THE COIL GOT STUCK. AS THE PHYSICIAN PULLED THE COIL, BACK HALF OF THE COIL BECAME LODGED BEHIND THE STENT AND THE OTHER HALF STRETCHED INSIDE THE ICA DOWN TO THE FEMORAL AND BROKE INTO 2 SEPARATE PIECES. IT WAS REPORTED THAT THE FIRST TWO LOOPS GOT LODGED BEHIND THE STENT. IT WAS REPORTED THAT THE SURGERY WAS DELAYED

  Patient problems: No Code Available

  MAUDE report 6504564 ↗