BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO

    MDR report key: 6193987 · Received December 21, 2016

    Report

    Report Number
    2029046-2016-00259
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 29, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    PMA / PMN Number
    K031161
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IN THE 3500A INITIAL REPORT, THE LOT# WAS REPORTED AS UNKNOWN. ON DECEMBER 15, 2016, THE LOT# WAS RECEIVED AND UPDATED FROM "UNKNOWN_D-1237-02-S " TO "17563530L" (B)(4). THE MANUFACTURE DATES HAVE BEEN UPDATED IN THE CORRESPONDING FIELDS OF THIS REPORT. ADDITIONAL INFORMATION WAS ALSO RECEIVED DECEMBER 21, 2016. THE PATIENT HAD PAROXYSMAL ATRIAL FIBRILLATION. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A ST. JUDE MEDICAL BRK NEEDLE. THE PATIENT RECEIVED ANTICOAGULANT DURING THE PROCEDURE WHICH WAS MAINTAINED AT 300-350 SECONDS. THE TAMPONADE OCCURRED DURING THE MAPPING PHASE, NO ABLATION HAD YET OCCURRED. THE EVENT WAS CONSIDERED LIFE THREATENING AND REQUIRED EXTENDED HOSPITALIZATION DUE TO THE LEFT ATRIAL APPENDAGE PERFORATION. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS PROCEDURE RELATED DURING COLLECTION OF THE FAST ANATOMICAL MAP. THERE ARE NO KNOWN FACTORS THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A LASSO VARIABLE CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THE PATIENT GRADUALLY BECOMING HYPOTENSIVE OVER SEVERAL HOURS. TAMPONADE WAS CONFIRMED VIA ULTRASOUND. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNKNOWN AMOUNT OF FLUID. REMAINDER OF PROCEDURE WAS ABORTED. PATIENT WAS STABILIZED AND TRANSFERRED TO THE OPERATING ROOM FOR A LEFT ATRIAL APPENDAGE (LAA) REPAIR. PATIENT CONDITION IMMEDIATELY AFTER THE EVENT WAS CRITICAL. PATIENT REQUIRED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. AT THE TIME THE COMPLAINT WAS REPORTED TO BIOSENSE WEBSTER INC, THE PATIENT REMAINED IN THE HOSPITAL AND WAS NOTED TO BE RECOVERING WELL. CARDIOVASCULAR MEDICAL HISTORY INCLUDES HYPERTENSION. IT IS BELIEVED THAT THE CATHETER PERFORATED THE LAA DURING FAST ANATOMICAL MAPPING (FAM). MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843223 LASSO CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1237-02-S UNKNOWN_D-1237-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O| R