BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROWLER MICROCATHETERS

    MDR report key: 5225303 · Received November 16, 2015

    Report

    Report Number
    1058196-2015-00204
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 23, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    KRA
    PMA / PMN Number
    K993266
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS ANTICIPATED THAT THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, THE DEVICE HAS NOT YET BEEN RETURNED. INFORMATION REGARDING PATIENT AGE, GENDER AND WEIGHT WERE NOT AVAILABLE. (B)(4). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS WAS COMPLETED ON 12/8/2015. AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF AN UNSPECIFIED HEMORRHAGE (PROCEDURE/TARGET VESSEL INFORMATION NOT AVAILABLE), THE PHYSICIAN EXPERIENCED RESISTANCE BETWEEN THE PROWLER PLUS ((B)(4)/16070470) AND THE GUIDEWIRE, AND THE GUIDEWIRE BECAME STUCK. IT WAS REPLACED WITH A TRANSIT TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURY/COMPLICATIONS. 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. NO VISIBLE DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO OR AFTER THE EVENT. IT WAS REPORTED THAT THE COMPLAINT DEVICE WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE. A NON-STERILE PROWLER PLUS 45CM TIP, 150CM WAS RECEIVED COILED INSIDE OF A PLASTIC BAG. THE DEVICE WAS INSPECTED AND IT WAS FOUND COMPRESSED. THE MICROCATHETER WAS INSPECTED UNDER MICROSCOPE, AND IT WAS FOUND COMPRESSED. THE ID OF THE MICROCATHETER WAS MEASURED AND FOUND WITHIN SPECIFICATION. THE RECEIVED MICROCATHETER WAS FLUSHED USING A LAB SAMPLE SYRINGE ((B)(4)), AND A GUIDE WIRE .018¿ LAB SAMPLE WAS INTRODUCED INTO THE MICROCATHETER AND COULD BE ADVANCE THROUGH OF THE DEVICE; HOWEVER, FRICTION WAS FELT WHEN THE GUIDE WIRE WAS PASSED THROUGH THE COMPRESSED SECTION FOUND ON THE MICROCATHETER. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT 16070470 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE MICROCATHETER OBSTRUCTION WAS NOT CONFIRMED AS THE DEVICE COULD BE FLUSHED AND A GUIDEWIRE WAS ABLE TO PASS THROUGH THE DEVICE; HOWEVER, THERE WAS RESISTANCE IN THE AREA OF THE MICROCATHETER COMPRESSION FOUND DURING ANALYSIS. THE RESISTANCE APPEARS TO BE DUE TO THE COMPRESSED SECTION NOTED ON THE RECEIVED MICROCATHETER. THE COMPRESSED SECTION FOUND ON THE MICROCATHETER WAS APPARENTLY CAUSED BY APPLYING EXCESSIVE FORCE ON THE DEVICE, BUT IT COULD NOT BE CONCLUSIVELY DETERMINED. NEITHER THE ANALYSIS NOR THE DHR SUGGEST THAT THE FAILURE REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS, AND PROCEDURAL FACTORS APPEAR TO HAVE CONTRIBUTED TO THIS FAILURE. ADDITIONALLY, INSPECTIONS ARE IN PLACE THAT PREVENTS THIS KIND OF FAILURE FROM LEAVING FROM THE MANUFACTURING FACILITY. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON 10/28/2015 THAT NO ADDITIONAL INFORMATION COULD BE PROVIDED. THE DEVICE WAS RETURNED FOR ANALYSIS ON 11/23/2015; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING TREATMENT OF AN UNSPECIFIED HEMORRHAGE (PROCEDURE/TARGET VESSEL INFORMATION NOT AVAILABLE), THE PHYSICIAN EXPERIENCED RESISTANCE BETWEEN THE PROWLER PLUS (6062511/16070470) AND THE GUIDEWIRE, AND THE GUIDEWIRE BECAME STUCK. IT WAS REPLACED WITH A TRANSIT TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WERE NO PATIENT INJURY/COMPLICATIONS. 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. NO VISIBLE DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO OR AFTER THE EVENT. IT WAS REPORTED THAT THE COMPLAINT DEVICE WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756797 PROWLER MICROCATHETERS CES MICROCATHETERS (KRA) KRA CODMAN AND SHURTLEFF, INC 16070470

    Patients

    Seq Age Sex Outcome Treatment
    1