BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR XTRA CARDIAC CRYOABLATION CATHETER

    MDR report key: 12741136 · Received November 2, 2021

    Report

    Report Number
    3002648230-2021-00499
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    October 28, 2020
    Report Date
    November 2, 2021
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/56 YEARS OLD. 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: EFFICACY OF CRYO-ABLATION DURING ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA. HEART AND VESSELS. 2021. 36:541¿548. DOI.ORG/10.1007/S00380-020-01717-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING CRYOBALLOON ABLATION. THE ARTICLE REPORTS PATIENTS WHO DEVELOPED TRANSIENT ATRIOVENTRICULAR BLOCK DURING THE ABLATION PROCEDURE. IN ONE PATIENT, AV CONDUCTION PROMPTLY RECOVERED AFTER CRYOABLATION WAS STOPPED AND THEN IT WAS PERFORMED AT A HIGHER SITE. IN OTHER PATIENTS, THE ABLATION PROCEDURE WAS STOPPED AND THEN RESUMED AT THE SITE JUST BELOW THE TRANSIENT AV BLOCK OBSERVED SITE. THE STATUS/DISPOSITION OF THE CATHETERS IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636657 FREEZOR XTRA CARDIAC CRYOABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 227F3

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other