BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER

    MDR report key: 6036586 · Received October 18, 2016

    Report

    Report Number
    2029046-2016-00226
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO SMART TOUCH UNIDIRECTIONAL APPROVED UNDER P030031/S053. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANTS USED DURING THIS STUDY: CARTO 3. METHOD: NO TESTING METHODS PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4).

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. THIS SUPPLEMENTAL IS A CORRECTION AS THE PRODUCT WAS FDA APPROVED. THEREFORE, PLEASE SEE THE CORRECTION IN COMMON DEVICE NAME. FDA PRODUCT CODE, COMMON DEVICE NAME, PMA/510(K) #. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED IN THE SURROUND FLOW CATHETER GROUP 2, 3 PATIENTS SHOWED ASYMPTOMATIC OESOPHAGEAL LESIONS (ERYTHEMA). BASED ON THE FACTS OF THE CASE AND THE AUTHOR¿S ASSESSMENT, THERE WERE NO REPORTED MALFUNCTION WITH ANY OF THE BWI CATHETERS AND SYSTEMS USED DURING THE CASE. THUS, THIS EVENT IS UNRELATED TO THE DEVICE AND MOST LIKELY RELATED TO THE PROCEDURE. TITLE: "IMPACT OF SURROUND FLOW CATHETER TIP IRRIGATION INCONTACT FORCE ABLATION ON THE INCIDENCE OF ASYMPTOMATIC OESOPHAGEAL LESIONS AFTER ATRIAL FIBRILLATION ABLATION: A PROSPECTIVE COMPARATIVE STUDY.¿ THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE IMPACT OF A RECENTLY INTRODUCED CONTACT FORCE ABLATION CATHETER WITH MODIFIED IRRIGATION TECHNOLOGY COMPARED WITH A CONVENTIONALLY IRRIGATED ABLATION CATHETER ON THE INCIDENCE OF ENDOSCOPICALLY DETECTED OESOPHAGEAL LESIONS (EDEL). HUNDRED PATIENTS WITH SYMPTOMATIC, DRUG-REFRACTORY PAROXYSMAL OR PERSISTENT ATRIAL FIBRILLATION (AF) WHO UNDERWENT LEFT ATRIAL RADIOFREQUENCY (RF) CATHETER ABLATION WERE PROSPECTIVELY ENROLLED. SUSPECTED DEVICE IS SMARTTOUCH THERMOCOOL SF ABLATION CATHETER, HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN. CONCOMITANTS USED DURING THIS STUDY: CARTO 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689953 THERMOCOOL® SMARTTOUCH® SF UNI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (IRWINDALE) D-1347-00 UNKNOWN_D-1347-00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other