BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7931206 · Received October 3, 2018

    Report

    Report Number
    3002648230-2018-00713
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 3, 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

    CONCOMITANT MEDICAL PRODUCTS: 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/WEIGHT FOR THE ¿ELDERLY GROUP¿ CHARACTERISTICS IS FEMALE/78 YEARS OLD/79 KG; BASELINE GENDER/AGE/WEIGHT FOR THE ¿CONTROL GROUP¿ CHARACTERISTICS IS MALE/60 YEARS OLD/91 KG. 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: SAFETY AND EFFICACY OF CRYOBALLOON ABLATION FOR THE TREATMENT OF ATRIAL FIBRILLATION IN ELDERLY PATIENTS.¿ CLINICAL RESEARCH IN CARDIOLOGY. HTTPS://DOI.ORG/10.1007/S00392-018-1336-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 WERE TWO (2) PATIENTS WHO EXPERIENCED PERICARDIAL TAMPONADE; WITH PERICARDIAL PUNCTURE TREATMENT, BUT NO SURGICAL TREATMENT WAS REQUIRED. THERE WERE ALSO PATIENTS WHO EXPERIENCED HEMATOMAS, AND AV FISTULAS; WITH UNKNOWN TREATMENT/RESOLUTION. EXTENDED HOSPITAL STAYS WERE REQUIRED FOR SOME PATIENTS. THERE WERE ALSO SEVEN (7) PATIENTS WHO HAD TRANSIENT PHRENIC NERVE PALSY (PNP); ALL OF WHICH RESOLVED ¿SPONTANEOUSLY¿ DURING FOLLOW UP. 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
    771946 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ACHIEVE MAPPING CATHETER