BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3890218 · Received June 24, 2014

    Report

    Report Number
    2029046-2014-00180
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. THE PRODUCT INVESTIGATION IS PENDING. CONCOMITANT BWI PRODUCTS: PRODUCT: STOCKERT 70 RF GENERATOR; US CATALOG # S7001; SERIAL # (B)(4). PRODUCT: COOLFLOW IRRIGATION PUMP; US CATALOG # CFP002; SERIAL # (B)(4). PRODUCT: CARTO 3 SYSTEM; US CATALOG # FG540000; SERIAL # (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Additional Manufacturer Narrative · 1

    AS THE LOT # 16076713M WAS PROVIDED, THE DEVICE HISTORY RECORD(S) 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.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. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT, UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA PROCEDURE WITH A THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT BECAME HYPOTENSIVE AND HAD A PERICARDIAL EFFUSION. THE PATIENT REQUIRED PERICARDIOCENTESIS, 200 CUBIC CENTIMETERS (CC) OF FLUID WERE REMOVED. NO FURTHER INFORMATION IS KNOWN REGARDING THE PATIENT STATUS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. PER 21 CFR, PART 803, THIS COMPLAINT IS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369145 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1327-05-S 16076713M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R