BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 10 - CERECYTE MICROCOIL

    MDR report key: 2921106 · Received January 17, 2013

    Report

    Report Number
    2954740-2013-00014
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    January 1, 2013
    Report Date
    December 26, 2012
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE AND LOT # ARE UNKNOWN. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER, IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS: PROWLER SELECT, ENVOY 100CM GUIDE CATHETER, ESCHELON MICROCATHETER, NEURO RENEGADE CATHETER, TRANSEND 182CM WIRE, ALLIGATOR RETRIEVAL DEVICE, .035 150CM GLIDEWIRE, AMPLATZ GOOSE NECK, STOPCOCK, THE BIG EASY, UNKNOWN PRESIDIO.

    Additional Manufacturer Narrative · 1

    DURING DELIVERY OF A PRESIDIO 6X26 COIL ((B)(4), LOT UNKNOWN), IT WAS DISCOVERED THAT THE COIL WAS DETACHED WITHOUT PUSHING THE DETACHMENT BUTTON. THE ECHELON MICROCATHETER WAS REMOVED AND A RENEGADE WAS PLACED AND THE COIL WAS RETRIEVED WITH A RETRIEVAL DEVICE (EITHER A GOOSE NECK OR ALLIGATOR). THE COIL WAS INSPECTED UPON REMOVAL AND APPEARED TO BE STRETCHED. THE RENEGADE WAS THEN REPLACED WITH A PROWLER AND COILING OF THE ANEURYSM WITH A SIMILAR COIL WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO DAMAGE NOTED ON THE COIL OR THE ECHELON MICROCATHETER PRIOR TO USE. IT IS UNKNOWN IF THERE WAS ANY DAMAGE TO THE MICROCATHETER AFTER USE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. IT IS UNKNOWN IF THE ENTIRE COIL PREMATURELY DETACHED FROM THE DELIVERY SYSTEM OR IF THE COIL BROKE IN TWO PIECES; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED IT APPEARED THAT PART OF THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY REPORTED. THE COIL WAS RETURNED SEVERELY DAMAGED AND STRETCHED AT THE PROXIMAL END. THE PROXIMAL END OF THE COIL UNRAVELED OUT OF THE SOLDERED SECTION. THE PART CONTAINING THE SOLDERED SECTION WITH THE COIL'S SOCKET RING WAS SEVERED AND NOT RETURNED. THE FRACTURE IS DUCTILE IN NATURE, WHICH REQUIRED EXTERNAL FORCE. NO MATERIAL DEFECTS WERE FOUND, AND THE DISTAL SECTION OF THE COIL WAS UNDAMAGED. THE DEVICE POSITIONING UNIT (DPU) WAS NOT RETURNED. DURING THE LABORATORY ANALYSIS, A BLOCKAGE CONSISTING OF ORGANIC (BLOOD MIXTURE) AND POLYMER MATERIAL WAS FOUND INSIDE THE MICROCATHETER BY INSERTING A 0.014 INCH GUIDE WIRE. IT WAS STATED THAT NO RESISTANCE WAS ENCOUNTERED DURING THE COILS ADVANCEMENT THROUGH THE MICROCATHETER; THEREFORE, THIS DEBRIS APPEARS TO HAVE BEEN POST-PROCEDURALLY INTRODUCED. AFTER THE BLOCKAGE WAS REMOVED, A TEST COIL WAS INTRODUCED INTO THE RETURNED ECHELON 14 MICROCATHETER MULTIPLE TIMES WITH NO PROBLEMS ENCOUNTERED. THE COIL WAS THEN ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE MICROCATHETER MULTIPLE TIMES WITH NO RESISTANCE ENCOUNTERED. AS THERE WAS NO RESISTANCE REGARDING ADVANCEMENT THROUGH THE MICROCATHETER REPORTED IN THE COMPLAINT, IT IS HIGHLY UNLIKELY THAT THIS MICROCATHETER OR THE DEBRIS FOUND INSIDE CONTRIBUTED TO THE COMPLAINT. THE EVIDENCE SUGGESTS THAT THE MOST LIKELY CONTRIBUTING FACTOR TO THE UNINTENDED DETACHMENT OF THE COIL INSIDE THE MICROCATHETER WAS THE COIL BECOMING ANCHORED. WHEN THE COIL WAS RETRACTED, THE ANCHORED PORTION WAS SEVERED FROM THE PROXIMAL END OF THE COIL THAT WAS ATTACHED TO THE DPU. HOWEVER, BASED ON LIMITED INFORMATION AVAILABLE, THE CIRCUMSTANCES OF HOW AND WHERE THE COIL BECAME ANCHORED DURING THE PROCEDURE CANNOT BE DETERMINED. IN ADDITION, WITHOUT THE RETURN OF THE DPU AND THE PROXIMAL END OF THE COIL, IT CANNOT BE DETERMINED IF THESE COMPONENTS CONTRIBUTED TO THE COMPLAINT EVENT. THE LOT NUMBER OF THE COMPLAINT PRODUCT IS REPORTED AS UNKNOWN; THEREFORE THE DHR REVIEW COULD BE COMPLETED. BASED ON THE FOREGOING ANALYSIS, THE ROOT CAUSE IS UNDETERMINED; THEREFORE, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    INITIAL MICROCATHETER USED WAS AN ESCHELON. DURING DELIVERY OF A PRESIDIO 6X26 COIL (PC41006263, LOT UNKNOWN), IT WAS DISCOVERED THAT THE COIL WAS DETACHED WITHOUT PUSHING THE DETACHMENT BUTTON. THE ESCHELON MICROCATHETER WAS REMOVED AND A RENEGADE WAS PLACED AND THE COIL WAS RETRIEVED WITH A RETRIEVAL DEVICE (EITHER THE GOOSE NECK OR THE ALLIGATOR). THE COIL WAS INSPECTED AND APPEARED TO BE STRETCHED. THE RENEGADE WAS THEN REPLACED WITH A PROWLER AND COILING OF THE ANEURYSM WAS COMPLETED WITHOUT FURTHER INCIDENT. A SIMILAR COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO DAMAGES NOTED ON THE COIL AND ESCHELON MICROCATHETER PRIOR TO USE. IT IS UNKNOWN IF THERE WERE ANY DAMAGES ON THE MICROCATHETER AFTER USE SINCE THIS WAS NOT NOTED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE WHEN THE COIL WAS ADVANCED THROUGH THE MICROCATHETER. IT IS UNKNOWN IF THE ENTIRE COIL PREMATURELY DETACHED FROM THE DELIVERY SYSTEM OR IF THE COIL BROKE IN TWO PIECES AND THE DELIVERY SYSTEM WAS REMOVED WITH PART OF THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26696 PRESIDIO 10 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention