BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER SELECT MICROCATHETERS

    MDR report key: 6544667 · Received May 4, 2017

    Report

    Report Number
    3008264254-2017-00049
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 14, 2017
    Report Date
    April 14, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    UDI-DI
    10886704028857
    PMA / PMN Number
    K021591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL/FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #3008264254-2017-00049. (B)(4). CONCOMITANT PRODUCT: GUIDEWIRE (CHIKAI14, ASAHI INTECC), GUIDING CATHETER (6FR SHUTTLE SHEATH, COOK INC/ 6FR ROADMASTER, GOODMAN), BALLOON CATHETER (SCEPTER XC). CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; HOWEVER 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. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT THERE WAS RESISTANCE FELT BETWEEN THE PROWLER SELECT PLUS (606-S255FX/17542524) AND THE GUIDEWIRE DURING A COIL EMBOLIZATION PROCEDURE AT THE MIDDLE CEREBRAL ARTERY. THE PROWLER SELECT PLUS (COMPLAINT PRODUCT) WAS ATTEMPTED TO BE USED BUT THERE WAS RESISTANCE ENCOUNTERED AT THE PROXIMAL PORTION WITH THE GUIDEWIRE WHEN IT WAS TREATED WITH STENT ASSIST. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS AND MILDLY CALCIFIED. REPORTEDLY, THE PATIENT¿S INFORMATION IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY/COMPLICATION REPORTED. 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 TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO (AND AFTER) THE EVENT. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326701 PROWLER SELECT MICROCATHETERS CATHETER, CONTINOUS FLUSH KRA CODMAN AND SHURTLEFF, INC NA 17542524 10886704028857

    Patients

    Seq Age Sex Outcome Treatment
    1