BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 4161856 · Received October 10, 2014

    Report

    Report Number
    1058196-2014-00259
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING COIL EMBOLIZATION OF THE PATIENT¿S PAVF AT THE CAROTID CAVERNOUS FISTULA, WHEN THE PHYSICIAN INSERTED THE PRESIDIO18 (PC4181240-30/C22636) INTO THE PROWLER SELECT PLUS (606-S255X/15866786), HE EXPERIENCED A RESISTANCE AROUND THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RECOVER THE COIL; HOWEVER, HE ALSO EXPERIENCED A RESISTANCE DURING WITHDRAWAL. THUS, THE COIL AND MICROCATHETER WERE BOTH WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES, AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU), AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS, ETC.) WAS NOTED ON THE PRODUCTS BY VISUAL INSPECTION, AND NO DAMAGES WERE REPORTED ON THE OTHER DEVICES AFTER THE EVENT. FURTHERMORE, NO UNINTENDED DEPLOYMENT OF THE COIL WAS OBSERVED IN EITHER THE VESSEL OR IN THE MICROCATHETER. SINCE THE COMPLAINT PRODUCTS HAVE ALREADY BEEN DISPOSED, THEY ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE RESISTANCE BETWEEN THE COIL AND MICROCATHETER COULD NOT BE CONFIRMED WITHOUT PRODUCT RETURN. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED AND FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT CANNOT BE IDENTIFIED WITHOUT ANALYSIS OF THE DEVICES. BASED ON THE INFORMATION PROVIDED AND THE REVIEW OF MANUFACTURING DOCUMENTATION, THERE IS NO EVIDENCE THE COMPLAINT WAS RELATED TO A MANUFACTURING ISSUE. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS 1 OF 2 MDRS SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MANUFACTURER REPORT NUMBERS OF 1058196-2014-00259 AND 2954740-2014-50008.

    Additional Manufacturer Narrative · 1

    INFORMATION REGARDING PATIENT DEMOGRAPHICS WERE NOT AVAILABLE. THIS IS 1 OF 2 MDRS SUBMITTED FOR PATIENT IDENTIFIER (B)(6). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF THE PATIENT¿S PAVF AT THE CAROTID CAVERNOUS FISTULA, WHEN THE PHYSICIAN INSERTED THE PRESIDIO18 (PC4181240-30/C22636) INTO THE PROWLER SELECT PLUS (606-S255X/15866786), HE EXPERIENCED A RESISTANCE AROUND THE PROXIMAL END OF THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO RECOVER THE COIL, HOWEVER HE ALSO EXPERIENCED A RESISTANCE DURING WITHDRAWAL. THUS, THE COIL AND MICROCATHETER WERE BOTH WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES, AND THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE COMPLAINT PRODUCTS WERE 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 PRODUCTS BY VISUAL INSPECTION, AND NO DAMAGES WERE REPORTED ON THE OTHER DEVICES AFTER THE EVENT. FURTHERMORE, NO UNINTENDED DEPLOYMENT OF THE COIL WAS OBSERVED IN EITHER THE VESSEL OR IN THE MICROCATHETER. SINCE THE COMPLAINT PRODUCTS HAVE ALREADY BEEN DISPOSED, THEY ARE NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639868 PROWLER SELECT MICROCATHETERS CES MICROCATHETERS (KRA) KRA CODMAN AND SHURTLEFF, INC 606S255X 15866768

    Patients

    Seq Age Sex Outcome Treatment
    1