BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH STEERABLE SHEATH

    MDR report key: 5452432 · Received February 22, 2016

    Report

    Report Number
    3002648230-2016-00057
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    December 23, 2015
    Report Date
    February 9, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K081049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC CRYOCATH WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE LITERATURE PUBLICATION OR TO MATCH THE EVENT WITH PREVIOUSLY REPORTED EVENTS. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 62 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: EVALUATION OF THE ACHIEVE MAPPING CATHETER IN CRYOABLATION FOR ATRIAL FIBRILLATION: A PROSPECTIVE RANDOMIZED TRIAL. J INTERV CARD ELECTROPHYSIOL. PUBLISHED ONLINE 23DECEMBER 2015. DOI 10.1007/S10840-015-0092-3. (B)(4)

    Description of Event or Problem · 1

    YI GANG <(>&<)> HANNEY GONNA <(>&<)> GIULIA DOMENICHINI <(>&<)> MICHAEL SAMPSON <(>&<)> NILOUFAR ARYAN <(>&<)> MARK NORMAN <(>&<)> ELIJAH R. BEHR <(>&<)> ZIA ZUBERI <(>&<)> PARAMDEEP DHILLON <(>&<)> MARK M. GALLAGHER. "EVALUATION OF THE ACHIEVE MAPPING CATHETER IN CRYOABLATION FOR ATRIAL FIBRILLATION: A PROSPECTIVE RANDOMIZED TRIAL." J INTERV CARD ELECTROPHYSIOL. PUBLISHED ONLINE 23DECEMBER 2015. DOI 10.1007/S10840-015-0092-3. ABSTRACT: PURPOSE THE PURPOSE OF THIS STUDY IS TO ESTABLISH THE ROLE OF ACHIEVE MAPPING CATHETER IN CRYOABLATION FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF) IN A RANDOMIZED TRIAL. METHODS A TOTAL OF 102 PATIENTS UNDERGOING THEIR FIRST ABLATION FOR PAF WERE RANDOMIZED AT 2:1 TO AN ACHIEVE- OR LASSO GUIDED PROCEDURE. STUDY PATIENTS WERE SYSTEMATICALLY FOLLOWED UP FOR 12 MONTHS WITH HOLTER MONITORING. PRIMARY STUDY ENDPOINT WAS ACUTE PROCEDURE SUCCESS. SECONDARY ENDPOINT WAS CLINICAL OUTCOMES ASSESSED BY AF FREE AT 6 AND 12 MONTHS AFTER THE PROCEDURE. RESULTS OF 102 PARTICIPANTS, 99 % OF ACUTE PROCEDURE SUCCESS WAS ACHIEVED. SIGNIFICANTLY SHORTER PROCEDURE DURATION WITH THE ACHIEVE-GUIDED GROUP THAN WITH THE LASSO-GUIDED GROUP (118+-8 VS. 129 &#6194;1 MIN, P <(><<)> 0.05) WAS OBSERVED AS WAS THE DURATION OF FLUOROSCOPY (17+- 5 VS. 20 +- 7 MIN, P <(><<)> 0.05) BY SUBGROUP ANALYSIS FOCUSED ON PROCEDURES PERFORMED BY EXPERIENCED OPERATORS. IN THE WHOLE STUDY PATIENTS, PROCEDURE AND FLUOROSCOPIC DURATIONS WERE SIMILAR IN THE ACHIEVE- (N=68) AND LASSO-GUIDED GROUPS (N = 34). TRANSIENT PHRENIC NERVE WEAKENING WAS EQUALLY PREVALENT WITH THE ACHIEVE AND LASSO. NO ASSOCIATION WAS FOUND BETWEEN CLINICAL OUTCOMES AND THE MAPPING CATHETER USED. THE USE OF SECOND-GENERATION CRYOBALLOON (N = 68) REDUCED PROCEDURE TIME SIGNIFICANTLY COMPARED TO THE FIRST-GENERATION BALLOON (N = 34); MORE PATIENTS WERE FREE OF AF IN THE FORMER THAN THE LATTER GROUP DURING FOLLOW-UP. CONCLUSIONS THE USE OF THE ACHIEVE MAPPING CATHETER CAN REDUCE PROCEDURE AND FLUOROSCOPIC DURATIONS COMPARED WITH LASSO CATHETERS IN CRYOABLATION FOR PAF AFTER OPERATORS GAINED SUFFICIENT EXPERIENCE. THE TYPE OF MAPPING CATHETER USED DOES NOT AFFECT PROCEDURE EFFICIENCY AND SAFETY BY MODELS OF CRYOBALLOON. THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATION: THERE WERE TWO PATIENTS WITH A FEMORAL HEMATOMA/PSEUDOANEURYSM WHICH REQUIRED A THROMBIN INJECTION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107868 FLEXCATH STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention