BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED INTRODUCER, 8.5F, SL1

    MDR report key: 3062924 · Received April 12, 2013

    Report

    Report Number
    3005188751-2013-00056
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS AN INHERENT RISK OF ANY TRANSSEPTAL PROCEDURE.

    Description of Event or Problem · 1

    RELATED TO MFR REFERENCE 2030404-2013-00029, 3005188751-2013-00054. DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE USING A THERAPY COOL FLEX ABLATION CATHETER, A CARDIAC PERFORATION OCCURRED. DURING SETUP AND WHILE CREATING GEOMETRY WITH THE VELOCITY SYSTEM, THE PHYSICIAN ENCOUNTERED SEVERAL ERROR MESSAGES AND A CATHETER DRIFT. RESPIRATORY COMPENSATION DID NOT RESOLVE THE CATHETER DRIFT, SO THE PHYSICIAN CONTINUED THE PROCEDURE USING FLUOROSCOPY AS WELL. THE PATIENT BECAME HYPOTENSIVE AND THEIR RESPIRATORY PATTERN CHANGED. ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION. THE PHYSICIAN STOPPED THE PROCEDURE AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. NO FURTHER INTERVENTION WAS REQUIRED. THE PHYSICIAN BELIEVES THE CARDIAC PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE OR WHILE MANIPULATING THE CATHETER NEAR THE MITRAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157833 SWARTZ BRAIDED INTRODUCER, 8.5F, SL1 TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407453 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention BARD DYNAMIC DECA CATHETER ((B)(4)/LOT UNKNOWN)| SUPREME EP CATHETER ((B)(4)/LOT UNKNOWN)| THERAPY COOL FLEX CATHETER ((B)(4)/LOT UNKNOWN)| SUPREME EP CATHETER ((B)(4)/LOT UNKNOWN)| BRK TRANSSEPTAL NEEDLE ((B)(4)/LOT UNKNOWN)| ENSITE VELOCITY SYSTEM (V3.0.1.1)