BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 3842050 · Received May 31, 2014

    Report

    Report Number
    1226348-2014-00119
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS REPORT 1 OF 2 FOR (B)(4). THE COMPLAINT RECEIVED STATES THAT THE PRESIDIO (PC4181447-30/M10229) HAD RESISTANCE/FRICTION AND THE COIL WAS UNRAVELED WHEN IT WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COIL EMBOLISATION ASSISTED WITH COMPETITOR¿S STENT FOR INTERNAL CAROTID TOP ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE PATIENT WAS A MALE OF (B)(6). DOB AND WEIGHT UNKNOWN. DURING THE PROCEDURE, WHILE INSERTING A PRESIDIO (PC4181447-30/M10229, COMPLAINT PRODUCT) IN AN UNSPECIFIED PROWLER SELECT PLUS (CATALOGUE AND LOT UNKNOWN), THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE ABOUT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. HOWEVER, WHEN THE PRESIDIO WAS WITHDRAWING FROM THE PATIENT, THE MICROCOIL OF THE PRESIDIO APPEARED TO BE UNRAVELED. THE REPORT DID NOT INDICATE WHERE ON THE MICROCOIL IT WAS LOCATED. THEREFORE BOTH THE PRESIDIO AND THE MICROCATHETER WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING AN UNSPECIFIED COMPETITOR¿S PRODUCT(BRAND NAME AND SIZE UNKNOWN). IT IS UNKNOWN IF THE MICROCATHETER WAS REPLACED OR NOT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. (B)(4). A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. (B)(4). NO CATALOGUE OR STERILE LOT NUMBER WERE PROVIDED THUS NO DHR COULD BE PERFORMED. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. 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 LIMITED INFORMATION SUGGESTS THAT PROCEDURAL, VESSEL AND TARGET SITE ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT THE PRESIDIO (PC4181447-30/M10229) HAD RESISTANCE/FRICTION AND THE COIL WAS UNRAVELED WHEN IT WAS REMOVED FROM THE MICROCATHETER. THE PROCEDURE WAS COIL EMBOLISATION ASSISTED WITH COMPETITOR¿S STENT FOR INTERNAL CAROTID TOP ARTERY ANEURYSM THAT WAS NOT CALCIFIED AND MILDLY TORTUOUS. THE PATIENT WAS A MALE OF (B)(6). DOB AND WEIGHT UNKNOWN. DURING THE PROCEDURE, WHILE INSERTING A PRESIDIO (PC4181447-30/M10229, COMPLAINT PRODUCT) IN AN UNSPECIFIED PROWLER SELECT PLUS (CATALOGUE AND LOT UNKNOWN), THE PHYSICIAN EXPERIENCED SEVERE RESISTANCE ABOUT 10CM FROM THE PROXIMAL END OF THE MICROCATHETER. HOWEVER, WHEN THE PRESIDIO WAS WITHDRAWING FROM THE PATIENT, THE MICROCOIL OF THE PRESIDIO APPEARED TO BE UNRAVELED. THE REPORT DID NOT INDICATE WHERE ON THE MICROCOIL IT WAS LOCATED. THEREFORE BOTH THE PRESIDIO AND THE MICROCATHETER WERE SAFELY REMOVED AS A UNIT FROM THE PATIENT. THE PROCEDURE WAS CONTINUED USING AN UNSPECIFIED COMPETITOR¿S PRODUCT (BRAND NAME AND SIZE UNKNOWN). IT IS UNKNOWN IF THE MICROCATHETER WAS REPLACED OR NOT. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. IT IS UNKNOWN IF THE MICROCATHETER WAS RE-SHAPED OR NOT. THE COMPLAINT PRODUCT IS UNAVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320493 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG MICRUS ENDOVASCULAR, LLC NA M10229

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR