BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PV TRACKER GUIDE WIRE

    MDR report key: 7488929 · Received May 4, 2018

    Report

    Report Number
    3002648230-2018-00289
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    April 20, 2018
    Report Date
    May 4, 2018
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OF THE PATIENTS REPRESENTED IN THE ARTICLE WITH THE PULMONARY VEIN ABLATION CATHETER IS MALE/57 YEARS OLD. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE WITH THE CRYOBALLOON ABLATION CATHETER IS MALE/59 YEARS OLD. OF NOTE, MULTIPLE PATIENTS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. 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: ¿COMPARING LEARNING CURVES OF TWO ESTABLISHED ¿SINGLE-SHOT¿ DEVICES FOR ABLATION OF ATRIAL FIBRILLATION.¿ JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. HTTPS://DOI.ORG/10.1007/S10840-018-0361-Z. 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 WHILE USING EITHER A CRYOBALLOON ABLATION CATHETER OR A PULMONARY VEIN ABLATION CATHETER SYSTEM: THERE WAS ONE (1) PATIENT WITH PERICARDIAL EFFUSION, WITH UNKNOWN TREATMENT/RESOLUTION. THERE WERE FOUR (4) PATIENTS WHO HAD BLEEDING; WITH UNKNOWN TREATMENT/RESOLUTION. THERE WAS ONE (1) PATIENT EACH WITH THE FOLLOWING COMPLICATIONS: STROKE, PLEURITIS, AV BLOCK, AND ST ELEVATION. THERE WERE THREE (3) PATIENTS WHO HAD TRANSIENT PHRENIC NERVE PALSY (PNP). THE STATUS/LOCATION OF THE 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
    330159 PV TRACKER GUIDE WIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC CRYOCATH LP 990045

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R