BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESIDIO 18 - CERECYTE MICROCOIL

    MDR report key: 4252454 · Received November 14, 2014

    Report

    Report Number
    2954740-2014-50036
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 22, 2014
    Report Date
    October 23, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    HCG
    PMA / PMN Number
    K002056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. WITHOUT THE DEVICE, THE REPORTED EVENT OF PREMATURE DETACHMENT COULD NOT BE CONFIRMED. WITH THE AVAILABLE TO DETERMINE THE CAUSE, BUT IT IS POSSIBLE THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY, RECORD REVIEW INDICATED THAT THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    DURING THE VRD-ASSISTED COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM AT THE PATIENT¿S ABDOMINAL AORTA, IT WAS REPORTED THAT THE PRESIDIO COIL (PC4181240-30/C23495) HAD ALREADY DETACHED WHEN ATTEMPTING TO INSERT THE DPU INTO THE PROWLER SELECT PLUS 2M 45° (LOT UNKNOWN) MICROCATHETER. SINCE THE COMPLAINT COIL COULD NOT BE INSERTED, IT WAS REPLACED WITH ANOTHER COIL WITH DIFFERENT LOT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY, AND THERE WERE ALSO NO PATIENT INJURY/COMPLICATIONS. ACCORDING TO THE PHYSICIAN, THE PREPARATION WAS CONDUCTED WITHOUT EXPERIENCING ANY PROBLEM. 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 TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICES AFTER THE EVENT. THE TORTUOSITY AND THE CALCIFICATION LEVEL OF THE PATIENT¿S VESSELS WERE ALSO UNKNOWN. NEITHER THE FURTHER DETAILS OF THE PATIENT NOR THE OTHER CONCOMITANT DEVICES ARE AVAILABLE. SINCE IT HAS ALREADY BEEN DISPOSED, THE COIL IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738475 PRESIDIO 18 - CERECYTE MICROCOIL CNV DCS COILS HCG CODMAN AND SHURTLEFF, INC PC418124030 C23495

    Patients

    Seq Age Sex Outcome Treatment
    1