BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN

    MDR report key: 8896257 · Received August 15, 2019

    Report

    Report Number
    2030404-2019-00073
    Event Type
    Injury
    Date Received
    August 15, 2019
    Report Date
    August 15, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LPB
    PMA / PMN Number
    P110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY IN AN ARTICLE TITLED ¿CATHETER ABLATION FOR SUPRAVENTRICULAR TACHYCARDIA IN CHILDREN =20 KG USING AN ELECTROANATOMICAL SYSTEM BY KOCA S, AKDENIZ C, AND TUZCU V, 17 DECEMBER 2018. ¿CATHETER ABLATION IS THE ONLY CHOICE OF TREATMENT IN SOME SMALL CHILDREN WITH MEDICALLY REFRACTORY SUPRAVENTRICULAR TACHYCARDIA (SVT). ELECTROANATOMICAL MAPPING SYSTEMS (EMS) ARE MORE COMMONLY UTILIZED IN ELECTROPHYSIOLOGICAL PROCEDURES IN RECENT YEARS, WHICH RESULTED IN A SIGNIFICANT DECREASE IN FLUOROSCOPY EXPOSURE. THE POTENTIAL BENEFIT OF EMS IN SMALL CHILDREN HAS NOT BEEN STUDIED. THEREFORE, WE INVESTIGATED THE OUTCOMES OF CHILDREN UNDERGOING CATHETER ABLATION WEIGHING = 20 KG USING AN ELECTROANATOMICAL MAPPING SYSTEM. IN A 6-YEAR PERIOD, 1129 CHILDREN UNDERWENT SVT CATHETER ABLATION UNDER EMS GUIDANCE AT OUR INSTITUTION. A TOTAL OF 84 OF THEM WERE WEIGHING = 20 KG. THE ACUTE SUCCESS RATE WAS 97.6% IN 85 TACHYCARDIA SUBSTRATES. NO FLUOROSCOPY WAS USED IN 58 OF THE PATIENTS, WHILE A MEDIAN OF 5 (4¿14) MIN OF FLUOROSCOPY WAS USED IN THE REMAINING 26 PATIENTS. RECURRENCES WERE SEEN IN 4 PATIENTS (4.8%) AT A MEAN FOLLOW-UP OF 3.89 ± 2.08 YEARS. FIVE PATIENTS DEVELOPED NON-VITAL COMPLICATIONS (2 RIGHT BUNDLE BLOCK AND 3 TEMPORARY COMPLETE BLOCK THAT SPONTANEOUSLY RESOLVED DURING THE PROCEDURE). (HTTPS://DOI.ORG/10.1007/S10840-018-0499-8)¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689692 THERAPY¿ COOL FLEX¿ ABLATION CATHETER, UNKNOWN IRRIGATED ABLATION CATHETER LPB ST. JUDE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention