BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY ABLATION CATHETER 7F, 1304-7-25-S

    MDR report key: 1970295 · Received January 14, 2011

    Report

    Report Number
    2030404-2011-00011
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P040014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONFIRMED THE COMPLAINT OF THE DISTAL TIP OF THE CATHETER BREAKING. THE CAUSE FOR THE REPORTED EVENT IS UNK. HOWEVER, ACCORDING TO THE COMPLAINT DESCRIPTION THE CATHETER WAS RESTERILIZED AND REUSED. THE IFU FOR THIS PRODUCT STATES "THIS CATHETER IS INTENDED FOR SINGLE USE ONLY. DO NOT RESTERILIZE OR AUTOCLAVE, AND REUSE. SINGLE-USE DEVICES ARE DESIGNED AND TESTED FOR ONLY ONE PT APPLICATION. THESE ARE DISPOSABLE ABLATION CATHETERS AND ARE NOT DESIGNED FOR REPROCESSING AND REUSE." REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 01/14/2011. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING THE PROCEDURE, THE DEVICE BROKE AND THE DISTAL TIP REMAINED INSIDE THE PT'S FEMORAL VEIN. THE DISTAL TIP WAS SUCCESSFULLY REMOVED BY A VASCULAR SURGEON. THIS DEVICE WAS A RESTERILIZED AND REUSED CATHETER. THE PT IS REPORTEDLY STABLE WITH NO FURTHER CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER 7F, 1304-7-25-S NONE OAD ST. JUDE MEDICAL, IRVINE 83432 REUSED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention