BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERIC - LASSO

    MDR report key: 6294899 · Received February 1, 2017

    Report

    Report Number
    2029046-2017-00023
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 9, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON APRIL 17, 2017. THE PATIENT SUFFERED A URINARY RETENTION POSTOPERATIVE (REQUIRING URINARY CATHETER RE-INSERTION AND AN UNSPECIFIED MEDICATION), URINARY TRACT INJURY/POST-PROCEDURAL HEMATURIA (REQUIRING NO MEDICAL OR SURGICAL INTERVENTION), AND HEMATURIA (REQUIRING AN UNSPECIFIED MEDICATION). CARDIOVASCULAR MEDICAL HISTORY INCLUDES HYPERLIPIDEMIA. LESS THAN 7 DAYS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INJURY. ISSUE RESOLVED WITHOUT SEQUELAE. NO INTERVENTION WAS ADMINISTERED. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. MORE THAN 7 DAYS POST-PROCEDURE, AFTER URINARY CATHETER REMOVAL, THE PATIENT EXPERIENCED HEMATURIA. MEDICATION (UNSPECIFIED) WAS ADMINISTERED. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, NOT DEVICE-RELATED, AND POSSIBLY INDEX PROCEDURE-RELATED. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON FEBRUARY 8, 2017 STATING THAT INTERVENTION TAKEN WAS TO RE-INSERT A FOLEY CATHETER AND FLOMAX MEDICATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANT PRODUCTS: CIRCULAR ABLATION CIRC LOOP CATHETER: MODEL #: D-1322-14-SI, LOT #: 17533023L. CIRCULAR ABLATION CIRC LOOP CATHETER: MODEL #: D-1322-14-SI, LOT #:17532611L. NMARQ GENERATOR: MODEL #: D-1341-07-I, SERIAL #: (B)(4). COOLFLOW PUMP: MODEL #: M-5491-131-I. SERIAL #: (B)(4).

    Description of Event or Problem · 1

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER, INC., DURING AN ABLATION PROCEDURE FOR SYMPTOMATIC ATRIAL FIBRILLATION WITH A LASSO CATHETER A (B)(6) MALE PATIENT SUFFERED URINARY RETENTION POSTOPERATIVE REQUIRING EXTENDED HOSPITALIZATION. THERE IS NO CARDIOVASCULAR MEDICAL HISTORY NOTED. LESS THAN 7 DAYS POST-PROCEDURE, THE PATIENT WAS DIAGNOSED WITH URINARY RETENTION. NO INTERVENTION WAS NECESSARY. PATIENT REQUIRED 1 DAY OF EXTENDED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT. ISSUE RESOLVED WITHOUT SEQUELAE. PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MILD IN SEVERITY, SERIOUS, NOT DEVICE-RELATED, AND POSSIBLY PROCEDURE-RELATED. IT WAS ALSO REPORTED THAT THERE WAS A NOT REPORTABLE TEMPERATURE ISSUE THAT OCCURRED WITH THE CIRCULAR ABLATION CIRC LOOP CATHETER DURING THE PROCEDURE. THIS CATHETER WAS NEVER INSERTED INTO THE PATIENT. THE CIRCULAR ABLATION CIRC LOOP CATHETER WAS REPLACED AND THE ISSUE RESOLVED. SINCE THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A RESULT OF THIS ADVERSE EVENT, THIS IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77021 GENERIC - LASSO DRF BIOSENSE WEBSTER, INC. (IRWINDALE) D-1220-00 UNKNOWN_LASSO

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization