MICRUSFRAME MFR100305Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886704077800), received between Aug 16, 2018 and Nov 4, 2023 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2023Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE COMPLAINT COIL, A 3MM X 5.4CM MICRUSFRAME 10 COIL (MFR100305 / 30810134) FAILED TO DETACH. IT WAS REPORTED THAT THE COIL WAS IN THE ANEURYSM BUT THE DETACHMENT SYSTEM FAILED SO THE COIL COULD NOT SEPARATE FROM THE DELIVERY WIRE. THEY CHANGED THREE (3) CABLES AND TWO (2) DETACHMENT BOXES, BUT IT DID NOT DETACH. THEY HAD TO REMOVE THE COIL. THE PROCEDURE WAS DELAYED; HOWEVER, THE DURATION WAS NOT REPORTED. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18070330 ↗
• MalfunctionJan 26, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION AND DURING THE RESHEATHING OF A 3MM X 5.4CM MICRUSFRAME10 COIL (MFR100305, L16030), THE INTRODUCER FAILED TO BE REZIPPED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228791 ↗
• MalfunctionAug 18, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FILED, DURING A COIL EMBOLIZATION, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT OF A 3MM X 5.4CM MICRUSFRAME10 (MFR 100305, L15956) AND DECIDED TO PULL IT OUT. DURING RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NOT PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10419763 ↗
• MalfunctionAug 6, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING THE PREPPING OF A 3MM X 5.4CM MICRUSFRAME10 COIL (MFR100305, L14989), THE SHEATH SPLIT. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED BY A COMPETITOR¿S COIL. THE PRODUCT WAS STORED ACCORDING TO LABELING INSTRUCTIONS. THE DEVICE WAS ADEQUATELY USED. THERE WAS NO EXCESSIVE FORCE APPLIED AT ANY TIME DURING THE PROCEDURE. THE COIL DEVICE WAS ATTEMPTED TO BE INSERTED INTO THE SL10 MICROCATHETER (MC). THERE WAS NO RESISTANCE/FRICTION ENCOUNTERED WHEN INSERTING THE COIL DELIVERY SYSTEM INTO THE MICROCATHETER. THERE WERE NO KINKS ON THE MC THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO EVIDENCE OF DAMAGE TO THE ACTUAL COIL (I.E. STRETCHING, KINKED, DETACHED, SEPARATED). BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865393 ↗
• InjuryJun 5, 2019Entrapment of Device; Migration; Entrapment of Device; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING THE ANEURYSM ON THE TERMINAL INTERNAL CAROTID ARTERY (ICA), A LOOP OF THE 3MM X 5.4CM MICRUSFRAME 10 COIL (MFR100305 / UNK LOT) IMPLANTED IN THE TARGET LESION WAS PUSHED OUT INTO THE PARENT VESSEL BY THE REPORTED STIFFNESS OF THE 2MM X 2CM DELTAPLUSH 10 COIL (DPL10020220/S10016). AS A RESULT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER) WAS SUBSEQUENTLY PLACED OVER THE PROTRUDING COIL LOOP TO SECURE THE COIL TO THE PARENT VESSEL WALL. A 2 MM X 2 CM BARRICADE¿ HELICAL COIL (BLOCKADE MEDICAL) WAS USED TO REPLACE THE DELTAPLUSH COIL AFTER THE STENT PLACEMENT WITHOUT INCIDENT; THE COIL WAS PLACED THROUGH THE STRUTS OF THE ATLAS STENT. THE COIL LOOP DID NOT CAUSE ANY RESTRICTION OR REDUCTION IN BLOOD FLOW; THERE WAS NO THROMBOSIS REPORTED AS A RESULT OF THE EVENT. THERE IS NO ADDITIONAL INTERVENTION PLANNED TO ADDRESS THE REMAINING COIL LOOP IN THE PARENT VESSEL; THE COIL LOOP WAS SECURED TO THE PARENT VESSEL WALL BY THE STENT. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE REPORTED EVENT. THE MICRUSFRAME COIL REMAINS IMPLANTED IN THE PATIENT AND IS THUS,

  Patient problems: No Code Available

  MAUDE report 8670595 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED VIA THE (B)(6) REGISTRY, A (B)(6) FEMALE (PATIENT (B)(6)), WITH A HISTORY OF CARDIAC ARRHYTHMIA, HEADACHES, SMOKING, AND CONTROLLED HYPERTENSION EXPERIENCED SEVERE INTRAOPERATIVE TARGET ANEURYSM RUPTURE DURING DEPLOYMENT OF A 3MM X 5.4CM MICRUSFRAME10 (MFR100305/L10115) THERMO-MECHANICAL COIL. LATER, A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L12447) THERMO-MECHANICAL COIL PARTIALLY PROTRUDED INTO THE ANEURYSM NECK AND PARENT VESSEL WITH CLOT, RESULTING IN NEAR VESSEL OCCLUSION FOR ONE MINUTE, BUT DID NOT RESULT IN PATIENT INJURY. AT THE TIME OF THE ANEURYSM RUPTURE, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE IMMEDIATELY DROPPED TO BELOW 100 AND THE PATIENT WAS ADMINISTERED 50MG OF PROTAMINE FOR HEPARIN REVERSAL AND A 250CC BOLUS OF 3% HYPERTONIC SALINE. THE PATIENT WAS HYPERVENTILATED, AND NEUROSURGERY WAS CONTACTED IMMEDIATELY. THEY WERE ABLE TO FINISH DEPLOYING THE NEUROFORM ATLAS (STRYKER) STENT WITH DETACHMENT AND RAPID COILING OF THE REMAINING COILS. THE SL-10 (STRYKER) MICROCATHETER WAS ADVANCED OVER THE TRAXCESS 14 (MICROVENTION) MICROWIRE ACROSS THE ANEURYSM NECK, SPANNING INTO THE RIGHT PERICALLOSAL ARTERY AND THE SECOND NEUROFORM ATLAS STENT WAS ADVANCED AND DEPLOYED

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 8071647 ↗
• MalfunctionAug 16, 2018Entrapment of Device; Positioning Problem; Entrapment of Device; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A 3.5 X 2.8 X 2.7MM RUPTURED ANEURYSM, THE 3MM X 5.4CM MICRUSFRAME10 (MFR100305/UNK LOT) THERMO-MECHANICAL FRAMING COIL APPEARED TO FIT PERFECTLY IN THE BEGINNING OF THE CASE, BUT THE PROXIMAL PORTION OF THE EMBOLIC COIL FAILED TO BREAK. THE COIL WAS SUPPLIED WITH A 3MM NON-CERENOVUS COIL, WHICH WAS CONSIDERED TOO SMALL. IT WAS FURTHER STATED THAT "THE LAST PART OF THE COIL DID NOT PERFORM LOOPS ANYMORE". THERE WAS NO REPORT OF CONSEQUENCE OF IMPACT TO THE PATIENT. IMAGING WAS PROVIDED BY THE CUSTOMER. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7789337 ↗