BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENT - BALLOON CATHETER

    MDR report key: 4086523 · Received September 12, 2014

    Report

    Report Number
    1226348-2014-00535
    Event Type
    Malfunction
    Date Received
    September 12, 2014
    Date of Event
    August 29, 2011
    Report Date
    August 29, 2011
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    MJN
    PMA / PMN Number
    K080861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS REPORT 1 OF 2 FOR (B)(4). CONT FROM EVENT DESCRIPTION: THE DPU WAS REMOVED AND SAVED. THERE WAS A RADIOPAQUE DOT SEEN ON THE IMAGE WHICH WAS CONFUSING. AS THE NEXT COIL WAS ADVANCED A DELTAPLUSH 1.5X1CM THE COIL WAS ADVANCED IT SEEM TO PUSH DOT OUT END OF ASCENT AND THE DOCTOR STOPPED; IT SEEMS THE RADIOPAQUE DOT WAS NOW NEAR THE ANEURYSM NECK OUT OF THE END OF THE ASCENT. (RA2) I DO NOT KNOW WHAT THE RADIOPAQUE DOT COULD BE. THEY DECIDED TO ADVANCE A MICROCATHETER ECHELON 10 WITH AN XPEDION 14 WIRE INTO THE ANEURYSM BESIDE THE ASCENT AND REMOVE THE ASCENT. THE DELTAPLUSH 1.5X1CM THAT WAS RESHEATHED WAS ADVANCED AND DETACHED THROUGH THE ECHELON 10. ALSO 4 OTHER COILS WERE USED WITH NO PROBLEM. THE PROCEDURE WAS NEAR COMPLETE AND POST ANGIOS WERE DONE SHOWING ALL VESSELS TO BE PATENT AND ANEURYSM TO BE OCCLUSIVE. THE RADIOPAQUE DOT WAS STILL IN VESSEL BELOW ANEURYSM NECK (R A2 AREA). THIS MDR IS BEING SUBMITTED AS PART OF RETROSPECTIVE REVIEW AS A RESULT OF A RECENT FDA AUDIT AND WITH ACCORDANCE TO THE REQUIREMENTS OF CODE OF FEDERAL REGULATIONS ¿ 21 CFR PART 803, MEDICAL DEVICE REPORTING. THE COMPLAINT RECEIVED SATES THAT DURING USE THE ASCENT BALLOON CATHETER 4 MM X 7 CM (BRS00040700 / F61039) HAD MARKER BAND DETACHMENT AND MIGRATION AND THE MICRUSPHERE 10 PLATINUM MICROCOIL 2 MM X 2.5 CM (SPH10020020 / F65887) HAD POOR CONFORMABILITY. THE COMPLAINT RECEIVED STATES THAT DURING USE THE (B)(6) ER-CASE SAH GRADE 3 ¿ COIL EMBOLIZATION WITH BALLOON REMODELING POSSIBLE. A 6FR COOK SHUTTLE SHEATH 80CM WAS ADVANCED INTO THE RCCA. A CONCENTRIC DAC 6.3 FR 070 ID TO THE RICA ;ANGIOS WERE PERFORMED SHOWING A A-COM ANEURYSM MEASURING 2.3X 2.6 MM WITH A NECK AS WIDE AS THE ANEURYSM. A 4X7ASCENT BALLOON WAS PREPPED ON THE BACK TABLE WITH NO PROBLEM WITH A SYNCHRO WIRE STD (014¿) AND ADVANCED THROUGH THE DAC CATHETER TO THE ANEURYSM. A MICRUSPHERE 2.5X 3.3CM BP COIL WAS ADVANCED THROUGH THE ASCENT BALLOON BUT WOULD NOT TAKE A SHAPE AS IT CAME OUT THE TIP OF THE ASCENT STRAIGHT. THE BALLOON WAS INFLATED AT THIS TIME. THE BALLOON WAS DEFLATED AND THE COIL WAS REMOVED AND RESHEATHED. THE DOCTOR ASKED FOR A 2MM X 2.5CM MICRUSPHERE BP AT THIS TIME AND THE COIL WAS ADVANCED AND BALLOON INFLATED AND AGAIN THE COIL WOULD NOT TAKE SHAPE KEPT COMING OUT STRAIGHT AGAINST THE DOME; THE BALLOON WAS DEFLATED AND PULLED BACK SOME AND THE COIL THEN TOOK SHAPE IN ANEURYSM THE BALLOON WAS INFLATED AND THE COIL ADVANCED AND REPOSITIONED A FEW TIMES WHEN THE COIL WAS IN GOOD POSITION THE DOCTOR COMMENTED THE PROXIMAL MARKER WAS NOT MATCHING UP WITH THE ASCENT 3CM MARKER. WHEN LINED UP CORRECTLY IT LOOKED LIKE COIL WAS STILL IN TIP OF ASCENT. I DID NOT HAVE AN EXPLANATION AND HE ADVANCED THE COIL PAST THE PROXIMAL MARKER TO WHERE THE COIL LOOKED LIKE IT WAS NO LONGER IN THE TIP OF THE ASCENT. HE DECIDED TO DETACH HERE AND THE DPU WAS REMOVED AND THE COIL WAS IN THE ANEURYSM. THE DPU WAS REMOVED AND SAVED. THERE WAS A RADIOPAQUE DOT SEEN ON THE IMAGE WHICH WAS CONFUSING. AS THE NEXT COIL WAS ADVANCED A DELTAPLUSH 1.5X1CM THE COIL WAS ADVANCED IT SEEM TO PUSH DOT OUT END OF ASCENT AND THE DOCTOR STOPPED; IT SEEMS THE RADIOPAQUE DOT WAS NOW NEAR THE ANEURYSM NECK OUT OF THE END OF THE ASCENT. (RA2) I DO NOT KNOW WHAT THE RADIOPAQUE DOT COULD BE. THEY DECIDED TO ADVANCE A MICROCATHETER ECHELON 10 WITH AN XPEDION 14 WIRE INTO THE ANEURYSM BESIDE THE ASCENT AND REMOVE THE ASCENT. THE DELTAPLUSH 1.5X1CM THAT WAS RESHEATHED WAS ADVANCED AND DETACHED THROUGH THE ECHELON 10. ALSO 4 OTHER COILS WERE USED WITH NO PROBLEM. THE PROCEDURE WAS NEAR COMPLETE AND POST ANGIOS WERE DONE SHOWING ALL VESSELS TO BE PATENT AND ANEURYSM TO BE OCCLUSIVE. THE RADIOPAQUE DOT WAS STILL IN VESSEL BELOW ANEURYSM NECK (R A2 AREA). (B)(4). THE MOST LIKELY CAUSE OF THE FORWARD MOVEMENT OF THE ASCENT¿S MARKER BAND OCCURRED AFTER MULTIPLE INFLATIONS AND DEFLATIONS OF THE BALLOON CATHETER. THIS PRESSURE CAUSED THE INNER MEMBER OF THE BALLOON TO COLLAPSE WHICH CAUSED THE MARKER BAND TO MIGRATE. THIS CAUSED THE MISALIGNMENT OF THE MARKER BAND OF THE DEVICE POSITIONING UNIT (DPU) UNDER FLUOROSCOPY. (B)(4). THE COIL WAS DETACHED IN THE ANEURYSM. THE MARKER BAND WAS CORRECTLY POSITIONED. THEREFORE IT IS HIGHLY UNLIKELY THE MICROCOIL CONTRIBUTED TO THE REPORTED RADIOPAQUE DOT. ALTHOUGH, UNRELATED TO THE COMPLAINT, IT WAS FOUND THAT THE RESHEATHING TOOL WAS ADVANCED OVER THE PROXIMAL END OF THE RESHEATHING TOOL. FOR OPTIMUM PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE IFU RECOMMENDS ¿RETURN TO THE INFUSION MICROCATHETER¿S RHV. LOOSEN THE RHV AND GENTLY SLIDE THE INTRODUCER TIP OUT FROM THE RHV, OVER THE DPU WIRE. ONCE A SMALL SECTION OF THE EXPOSED DPU WIRE IS VISIBLE, TIGHTLY GRASP IT WITH THUMB AND FOREFINGER OF THE SAME HAND THAT IS HOLDING THE RHV. USING THE THUMB AND FOREFINGER OF YOUR OTHER HAND, GRASP THE INTRODUCER TIP, SLOWLY SLIDE IT AWAY FROM THE RHV OVER THE DPU WIRE. CONTINUE SLIDING THE INTRODUCER TIP UNTIL JUST BEFORE THE TIP REACHES THE DISTAL END OF THE RESHEATHING TOOL, LEAVING APPROXIMATELY 1 INCH ON THE UNSHEATHED INTRODUCER STILL VISIBLE¿ THE COMPLAINT OF MARKER BAND DISLODGEMENT WAS CONFIRMED ON ANALYSIS. THE POOR CONFORMABILITY OF THE COIL COULD NOT BE EVALUATED BECAUSE IT WAS SUCCESSFULLY USED. 100% INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT DEVICE AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED AND CONFIRMED EVENTS.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED SATES THAT DURING USE THE ASCENT BALLOON CATHETER 4 MM X 7 CM (BRS00040700 / F61039) HAD MARKER BAND DETACHMENT AND MIGRATION AND THE MICRUSPHERE 10 PLATINUM MICROCOIL 2 MM X 2.5 CM (SPH10020020 / F65887) HAD POOR CONFORMABILITY. THE COMPLAINT RECEIVED STATES THAT DURING USE THE (B)(6) ER-CASE SAH GRADE 3 ¿ COIL EMBOLIZATION WITH BALLOON REMODELING POSSIBLE. A 6FR COOK SHUTTLE SHEATH 80CM WAS ADVANCED INTO THE RCCA. A CONCENTRIC DAC 6.3 FR 070 ID TO THE RICA ;ANGIOS WERE PERFORMED SHOWING A A-COM ANEURYSM MEASURING 2.3X 2.6 MM WITH A NECK AS WIDE AS THE ANEURYSM. A 4X7ASCENT BALLOON WAS PREPPED ON THE BACK TABLE WITH NO PROBLEM WITH A SYNCHRO WIRE STD (014¿) AND ADVANCED THROUGH THE DAC CATHETER TO THE ANEURYSM. A MICRUSPHERE 2.5X 3.3CM BP COIL WAS ADVANCED THROUGH THE ASCENT BALLOON BUT WOULD NOT TAKE A SHAPE AS IT CAME OUT THE TIP OF THE ASCENT STRAIGHT. THE BALLOON WAS INFLATED AT THIS TIME. THE BALLOON WAS DEFLATED AND THE COIL WAS REMOVED AND RESHEATHED. THE DOCTOR ASKED FOR A 2MM X 2.5CM MICRUSPHERE BP AT THIS TIME AND THE COIL WAS ADVANCED AND BALLOON INFLATED AND AGAIN THE COIL WOULD NOT TAKE SHAPE KEPT COMING OUT STRAIGHT AGAINST THE DOME; THE BALLOON WAS DEFLATED AND PULLED BACK SOME AND THE COIL THEN TOOK SHAPE IN ANEURYSM THE BALLOON WAS INFLATED AND THE COIL ADVANCED AND REPOSITIONED A FEW TIMES WHEN THE COIL WAS IN GOOD POSITION THE DOCTOR COMMENTED THE PROXIMAL MARKER WAS NOT MATCHING UP WITH THE ASCENT 3CM MARKER. WHEN LINED UP CORRECTLY IT LOOKED LIKE COIL WAS STILL IN TIP OF ASCENT. I DID NOT HAVE AN EXPLANATION AND HE ADVANCED THE COIL PAST THE PROXIMAL MARKER TO WHERE THE COIL LOOKED LIKE IT WAS NO LONGER IN THE TIP OF THE ASCENT. HE DECIDED TO DETACH HERE AND THE DPU WAS REMOVED AND THE COIL WAS IN THE ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564393 ASCENT - BALLOON CATHETER CES BALLOON CATHETER MJN MICRUS ENDOVASCULAR, LLC NA F61039

    Patients

    Seq Age Sex Outcome Treatment
    1