BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXCATH ADVANCE STEERABLE SHEATH

    MDR report key: 7735814 · Received July 31, 2018

    Report

    Report Number
    3002648230-2018-00515
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    January 1, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONTINUATION OF CONCOMITANT PRODUCTS: ACHIEVE MAPPING 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. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LOT NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/57 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. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ¿SINGLE 3-MIN FREEZE PER VEIN ABLATION STRATEGY WITH THE SECOND-GENERATION CRYOBALLOON FOR ATRIAL FIBRILLATION IN A LARGE COHORT OF PATIENTS: LONG TERM OUTCOME AFTER A SINGLE PROCEDURE.¿ JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. PUBLISHED ONLINE 13JUNE2018. HTTPS://DOI.ORG/10.1007/S10840-018-0393-4. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE LITERATURE PUBLICATION REPORTS THE FOLLOWING PATIENT COMPLICATIONS WHILE USING A CRYOABLATION BALLOON ABLATION SYSTEM: THERE WERE EIGHT (8) PATIENTS WHO EXPERIENCED PHRENIC NERVE PALSY (PNP); ALL, BUT ONE, CASES HAD RESOLVED BY HOSPITAL DISCHARGE. THE ONE (1) PATIENT HAD PERSISTENT PNP AT THE FINAL FOLLOW UP. THERE WERE TEN (10) PATIENTS WHO EXPERIENCED VASCULAR ACCESS COMPLICATIONS; SOME OF WHICH RESULTED IN A LONGER HOSPITALIZATION, ALONG WITH ONE SURGICAL INTERVENTION. THE STATUS/LOCATION OF THE CRYOBALLOON 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
    578305 FLEXCATH ADVANCE STEERABLE SHEATH CATHETER, STEERABLE DRA MEDTRONIC CRYOCATH LP 4FC12

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER