BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR

    MDR report key: 5993503 · Received October 3, 2016

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    Report

    Report Number
    9612355-2016-00053
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 6, 2016
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    UDI-DI
    4260166371390
    PMA / PMN Number
    P990071/S017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR AN ATRIAL FLUTTER WITH A SMARTABLATE GENERATOR AND SUFFERED SECOND DEGREE BURNS (CONSERVATIVELY). THE BURN CLASSIFICATION HAS NOT YET BEEN CONFIRMED. THERE IS NO INFORMATION REGARDING ANY INTERVENTIONS OR IF THERE WAS ANY EXTENDED HOSPITALIZATION. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE PHYSICIAN WAS USING A MAESTRO CATHETER (NON BIOSENSE WEBSTER, INC.) AND THEN SWITCHED OVER TO A SMART TOUCH UNIDIRECTIONAL CATHETER. IT WAS NOTED THAT THE PHYSICIAN DOES NOT KNOW WHEN THE BURN OCCURRED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. THE DEVICE WAS EVALUATED AND NO ERROR WAS FOUND. THE DEVICE WAS WITHIN SPECIFICATION. THE DEVICE WAS SUBJECTED TO A PREVENTATIVE MAINTENANCE, SAFETY AND FUNCTIONAL TESTING AND ALL TESTS PASSED. NO DEVICE MALFUNCTION FOUND. THE DEVICE HISTORY RECORD (DHR) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR AN ATRIAL FLUTTER WITH A SMARTABLATE GENERATOR AND SUFFERED SECOND DEGREE BURNS (CONSERVATIVELY). THE BURN CLASSIFICATION HAS NOT YET BEEN CONFIRMED. THERE IS NO INFORMATION REGARDING ANY INTERVENTIONS OR IF THERE WAS ANY EXTENDED HOSPITALIZATION. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. THE PHYSICIAN WAS USING A MAESTRO CATHETER (NON BIOSENSE WEBSTER, INC.) AND THEN SWITCHED OVER TO A SMART TOUCH UNIDIRECTIONAL CATHETER. IT WAS NOTED THAT THE PHYSICIAN DOES NOT KNOW WHEN THE BURN OCCURRED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THIS ADVERSE EVENT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646749 SMARTABLATE¿ SYSTEM RF GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH M-4900-07 4260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 Other