BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 7531087 · Received May 21, 2018

    Report

    Report Number
    2029046-2018-01572
    Event Type
    Death
    Date Received
    May 21, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835008982
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/19/2018 INDICATING THAT A DEATH OCCURRED AND IS RELATED TO THIS EVENT. MANUFACTURER REF NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED A VASCULAR DISSECTION REQUIRING NO MEDICAL OR SURGICAL INTERVENTION. DURING THE PROCEDURE, THE TRUNK OF THE AORTA WAS DISSECTED. THERE WERE NO INTERVENTIONS. REMAINDER OF PROCEDURE WAS ABORTED. IT HAS NOT BEEN CONFIRMED IF THE INJURY WAS CAUSED BY THE CATHETER. THERE WERE NO ISSUES OR ERRORS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. 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
    371254 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC UNK 10846835008982

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L