BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 8057603 · Received November 9, 2018

    Report

    Report Number
    3002648230-2018-00804
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DRA
    PMA / PMN Number
    K123591
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF MEDICAL DEVICES: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER MEDTRONIC 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 EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/65 YEARS OLD. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT/SERIAL NUMBERS. 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: NOVEL SPIRAL MAPPING CATHETER FACILITATES OBSERVATION OF THE TIME-TO-PULMONARY VEIN ISOLATION DURING CRYOBALLOON ABLATION.¿ HEART AND VESSELS. PUBLISHED ONLINE 2018-10-09. HTTPS://DOI.OR G/10.1007/S00380-018-1254-X . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTED THE FOLLOWING PATIENT COMPLICATIONS DURING THE USE OF A CRYOBALLOON ABLATION SYSTEM: THERE WAS ONE (1) PATIENT WHO DEVELOPED CARDIAC TAMPONADE; WITH UNKNOWN TREATMENT/RESOLUTION. THERE WERE ALSO ELEVEN (11) PATIENTS WHICH HAD PHRENIC NERVE PALSY (PNP); ALL OF WHICH RESOLVED BY THE END OF THE PROCEDURE. THERE WERE EIGHT (8) PATIENTS WHO HAD GROIN-SITE COMPLICATIONS (HEMATOMAS); WITH NO NEED FOR BLOOD TRANSFUSIONS. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT LOT NUMBERS. THE STATUS/LOCATION OF THE CRYOABLATION SYSTEM IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896648 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R