BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRUSFRAME COIL

    MDR report key: 7133208 · Received December 20, 2017

    Report

    Report Number
    3013875781-2017-00048
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    October 10, 2017
    Report Date
    October 10, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    UDI-DI
    10886704078173
    PMA / PMN Number
    K150319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT MET MDR REPORTING CRITERIA WHEN DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS KINKED. MFG NAME: CODMAN & SHURTLEFF, INC. DBA DEPUY SYNTHES PRODUCTS, INC. CUSTOMER INFORMATION COULD NOT BE PROVIDED. INFORMATION IS FOR THE (B)(4) AFFILIATE. INFORMATION REGARDING AGE, WEIGHT, GENDER, MEDICAL HISTORY AND CONCOMITANT DEVICES WERE NOT AVAILABLE. CONCLUSION: THE DEVICE WAS RETURNED WITH ITS INNER POUCH. LABELING ON THE INNER POUCH MATCHES THE PRODUCT DOCUMENTED IN THE COMPLAINT. THE EMBOLIC COIL IS TANGLED AROUND THE REST OF THE DEVICE. THE EMBOLIC COIL WAS GENTLY UNTANGLED. THE EMBOLIC COIL AND DISTAL END OF THE DEVICE POSITIONING UNIT (DPU) PROTRUDE FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. THERE ARE BENDS IN THE DPU CORE WIRE APPROXIMATELY 48 CM AND 75 CM FROM THE PROXIMAL END. THE BALL TIP IS INTACT. THERE IS BLOOD ON THE EMBOLIC COIL. THE EMBOLIC COIL IS KINKED. THE ARTICULATING JOINT IS INTACT. THE RESISTANCE HEATING (RH) COIL HAS NOT RECEIVED HEAT. THE TIP COIL SECTION OF THE DPU PROTRUDES FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH PROXIMAL TO THE MARKER BAND. THE V-NOTCH OF THE RESHEATHING TOOL IS UNDAMAGED. THERE IS BLOOD IN THE GREEN INTRODUCER. THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH IS PARTIALLY OPEN. THERE IS BLOOD IN THE TRANSLUCENT INTRODUCER SHEATH. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT THAT THE PRESCORE WAS RUPTURED WAS CONFIRMED. THE DISTAL END OF THE DPU AND THE EMBOLIC COIL PROTRUDED FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH. WHILE THE EXACT CIRCUMSTANCES OF THE EVENT ARE UNKNOWN, THE KINKED EMBOLIC COIL, BENDS IN THE DPU CORE WIRE, AND PROTRUSION OF THE DISTAL END OF THE DEVICE FROM THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH SUGGEST THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE, POSSIBLY IN AN ATTEMPT TO OVERCOME RESISTANCE. THE APPLIED FORCE MAY HAVE CAUSED THE DPU CORE WIRE TO PROTRUDE THROUGH THE SKIVE OF THE TRANSLUCENT INTRODUCER SHEATH TO THE POINT WHERE THE EMBOLIC COIL WAS FREED FROM THE INTRODUCER. AT THAT POINT, THE DPU CORE WIRE MAY HAVE BEEN RETRACTED TO THE POINT WHERE THE TIP COIL RE-ENTERED THE TRANSLUCENT INTRODUCER SHEATH. THE KINK IN THE TIP COIL WHERE IT PROTRUDES THROUGH THE TRANSLUCENT INTRODUCER SHEATH WOULD HAVE PREVENTED ANY ADDITIONAL PARTS OF THE DPU FROM RE-ENTERING THE SHEATH. RESISTANCE MAY HAVE BEEN DUE TO INSUFFICIENT MAINTENANCE OF FLUSH, AS EVIDENCED BY THE PRESENCE OF BLOOD IN THE INTRODUCER AND ON THE EMBOLIC COIL. THE IFU STATES THAT CONTINUOUS INFUSION OF AN APPROPRIATE FLUSH SOLUTION IS REQUIRED FOR OPTIMAL PERFORMANCE, AND ALSO INDICATES THAT THE FLUSH SHOULD BE VERIFIED IN THE EVENT OF RESISTANCE. INSUFFICIENT FLUSH ALLOWS BLOOD TO BACK-FLOW INTO THE MICROCATHETER, WHICH CAN CAUSE RESISTANCE. THERE ARE NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM, A MICRUSFRAME 18 (MFR182050/ S13741) SHEATH INTRODUCER SPLIT OPEN EXPOSING THE DELIVERY WIRE AND DURING PRODUCT ANALYSIS, THE COIL WAS FOUND TO BE KINKED. THE SHEATH INTRODUCER WAS INSERTED INTO THE UNSPECIFIED MICROCATHETER AND THE DELIVERY WIRE WAS ADVANCED, BUT THE SHEATH INTRODUCER WAS SPILT OPEN AND THE DELIVERY WIRE EXPOSED. THERE HAD BEEN NO RESISTANCE BETWEEN THE COIL AND MICROCATHETER. EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. NO REPORT OF THE OTHER DEVICE USED IN THE PROCEDURE IS AVAILABLE. 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 PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR INVESTIGATION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913096 MICRUSFRAME COIL NEUROVASCULAR EMBOLIZATION DEVICE HCG MEDOS INTERNATIONAL SARL NA S13741 10886704078173

    Patients

    Seq Age Sex Outcome Treatment
    1