MICRUSFRAME MFR141025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704077916), received between Nov 15, 2017 and May 11, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2018Unraveled Material; Unraveled Material

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A SPLENIC ARTERY ANEURYSM, THE PHYSICIAN USED THE 4F ANGIO-CATHETER AND INSERTED THE MICROCATHETER (CARNELIAN SI, TOKAI MEDICAL PRODUCTS) AND WAS ABLE TO DELIVER THE FIRST COIL, A 12 MM MICRUSFRAME18 COIL TO THE TARGET VESSEL AT THE PERIPHERAL SPLENIC ARTERY. WHEN THE MICRUSFRAME14 10 MM X 25 CM (MFR141025 / S12423) WAS INSERTED INTO THE MICROCATHETER, IT BECAME STUCK AND BECAME UNRAVELED WHEN IT WAS BEING REMOVED FROM THE MICROCATHETER. ANOTHER MICRUSFRAME14 10 MM X 25 CM COIL (MFR141025 / S13354) WAS FLUSHED AND INSERTED INTO THE MICROCATHETER. IT BECAME STUCK AND THE SHEATH INTRODUCER BECAME DAMAGED DURING REMOVAL. THE CARNELIAN SI MICROCATHETER WAS REPLACED WITH THE PROWLER SELECT PLUS MICROCATHETER AND ANOTHER MICRO COIL OF THE SAME SIZE WAS DELIVERED TO THE TARGET SITE WITHOUT ANY ISSUE. A TRUFILL COMPLEX PUSH COIL (633350X / 17274196) WAS INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER AND IT BECAME STUCK IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED FROM THE TARGET SITE AND FLUSHED TO REMOVE THE TRUFILL COIL. WITH CONTINUOUS RE-FLUSHING, ANOTHER TRUFILL COIL WAS DELIVER AND IMPLANT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7508417 ↗
• MalfunctionFeb 26, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  A REPORT WAS RECEIVED THAT DURING A COIL EMBOLIZATION FOR A SUBARACHNOID HEMORRHAGE AT THE 11 MM MIDDLE CEREBRAL ARTERY ANEURYSM, THE 10 MM X 25 CM MICRUSFRAME14 THERMO-MECHANICAL DETACHABLE COIL DELIVERY SYSTEM (DCS) (MFR141025/S13431) WAS SELECTED AS FIRST COIL, INSERTED, AND USED, BUT ¿IT WAS MADE A SMALL COMPARTMENT¿. THEREFORE, THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL BUT THE ZIPPER COULD NOT BE SHUT. IT WAS FLUSHED WITH SALINE AND ZIPPING WAS CONDUCTED, BUT THE INTRODUCER SPLIT OPEN AND THE COIL FAILED TO RESHEATH. THE COIL WAS SUBSEQUENTLY REPLACED. 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 NEITHER TORTUOUS NOR CALCIFIED. A FUBUKI (ASAHI INTECC), A HEADWAY (TERUMO) MICROCATHETER, A Y-CONNECTOR (TERUMO), A SCEPTER (TERUMO) BALLOON CATHETER, AN ENPOWER, AND DCB02 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. AN APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THE SCEPTER (TERUMO) BALLOON CATHETER AND MICROCATHETER WERE INSERTED INTO THE GUIDING CATHETER AS A UNIT AND APPROACHED TO THE TARGET LESION. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELIN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295847 ↗
• MalfunctionNov 15, 2017Premature Activation; Physical Resistance; Premature Activation; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF A RIGHT INTERNAL ILIAC ANEURYSM, THERE WAS RESISTANCE BETWEEN A MICRUSFRAME 14 (MFR141025, S13011) AND A LIGHTHOUSE MICROCATHETER, AND THE DELIVERY WIRE KINKED AND DURING PRODUCT ANALYSIS, THE COIL WAS FOUND TO BE DETACHED. THE FIRST COIL (MICRUSFRAMES18 13 MM X 43 CM) AND SECOND COIL (MICRUSFRAMES18 12 MM X 40 CM) WERE SELECTED AND THEY WERE PREPARED ACCORDING TO IFU AND WERE PLACED WITHOUT ANY PROBLEM. NEXT, THE MICRUSFRAME14 (COMPLAINT PRODUCT) WAS INSERTED ACCORDING TO IFU, BUT THERE WAS RESISTANCE FELT AT THE PORTION WHERE THE TIP OF THE COIL ENTERS INTO THE MICROCATHETER. FURTHERMORE, THE RESISTANCE BECAME STRONGER ON THE WAY AND THE DELIVERY WIRE KINKED. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. HOWEVER, DUE TO THE EVENT IT WAS DELAYED FOR 5 MINUTES. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7032798 ↗