BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MW5081021

    MDR report key: 8033015 · Received November 1, 2018

    Report

    Report Number
    MW5081021
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 29, 2018
    Report Date
    October 30, 2018
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PATIENT PRESENTED WITH ACUTE ISCHEMIC STROKE WITH THE LEFT HEMIPARESIS AND FOUND TO HAVE A LARGE UNRUPTURED 8 MM BASILAR TIP ANEURYSM. PATIENT TAKEN FOR DIAGNOSTIC CEREBRAL ANGIOGRAM AND FOR COIL EMBOLIZATION ARTERY TIP ANEURYSM WITH BALLOON ASSISTANCE. THE RIGHT COMMON FEMORAL ARTERY WAS ACCESSED USING MICROPUNCTURE NEEDLE, WHICH WAS EXCHANGED OUT FOR MICROSHEATH WHICH WAS THEN EXCHANGED OUT FOR AN 8-FRENCH 10 CM SHEATH OVER A J-WIRE. A SHEATH CONNECTED TO A CONTINUOUS HEPARINIZED SOLUTION. THROUGH THE SHEATH, WAS ADVANCED A TRIAXIAL SYSTEM OF NEURON MAX 80 MM OVER 125 BERNSTEIN DIAGNOSTIC CATHETER AND GLIDEWIRE. DIAGNOSTIC CATHETER AND GLIDEWIRE REMOVED AND BIPLANE ANGIOGRAPHY OVER THE HEAD SHOWED PREVIOUSLY DESCRIBED 5-MM BASILAR TIP ANEURYSM. NEXT, USING ROADMAP TECHNIQUE, ADVANCED A SCEPTER SC BALLOON MICROCATHETER OVER SYNCHRO-2 STRANDED MICROWIRE INTO THE BASILAR ARTERY WITH THE WIRE INTO THE RIGHT POSTERIOR CEREBRAL ARTERY. NEXT, WAS ADVANCED A HEADWAY 17 CURVED MICROCATHETER OVER SYNCHRO-2 MICROWAVE THROUGH THE GUIDE CATHETER FURTHER INTO THE BASILAR ARTERY AND CAREFULLY MICROCATHERIZED THE ANEURYSM. MICROWIRE WAS REMOVED. FOLLOW-UP ANGIOGRAM SHOWED EXCELLENT MICROCATHERIZATION WITH NO EVIDENCE OF INTRAPROCEDURAL RUPTURE. NEXT, ADVANCED A TOTAL OF 6 COILS SEQUENTIALLY INTO THE ANEURYSM. THE FIRST TWO DID NOT DETACH. HYDROFRAME 18, 8 MM X 27 MM, REMOVED AS IT DID NOT WANT TO GO THROUGH THE MICROCATHETER, HYDROFRAME 10, 8 MM X 33 CM, REMOVED, DID NOT DETACH DESPITE 2 DETACHMENT SYSTEMS USED. THE LAST 4 WERE PLACED INTO THE ANEURYSM WITHOUT DIFFICULTY. THE 8-MM BASILAR ARTERY TIP WAS SUCCESSFULLY EMBOLIZED WITH 4 LARGE COILS USING BALLOON ASSISTANCE WITH NO RESIDUAL.

    Patients

    Seq Age Sex Outcome Treatment
    0