BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SF UNI-DIRECTIONAL CATHETER

    MDR report key: 6041820 · Received October 19, 2016

    Report

    Report Number
    9673241-2016-00712
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    June 30, 2016
    Report Date
    September 25, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. CONCOMITANTS USED DURING THIS STUDY: 10 F SOUND STARPROBE; LASSO; THERMOCOOL SF. OTHER COMPANY'S WERE USED IN THIS STUDY: A 10 F ACUNAV PROBE (SIEMENS MEDICAL SOLUTIONS, DISTRIBUTED BY BIOSENSE WEBSTER); VIVID I SYSTEM (GE HEALTHCARE, (B)(4)); CYPRESS SYSTEM (ACUSON CORP, (B)(4)). MANUFACTURER'S REF. NO: (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. IT WAS REPORTED ONE STROKE/THROMBOEMBOLIC EVENT (TRANSIENT ISCHEMIC ATTACK) WITH POSITIVE DMRI OCCURRED IN A PATIENT ON UNINTERRUPTED RIVAROXABAN (20 MG ONCE A DAY) HAVING LONG-STANDING PERSISTENT TYPE OF AF. THE PATIENT WAS ELECTRICALLY CARDIOVERTED DURING THE ABLATION PROCEDURE TO ACHIEVE SINUS RHYTHM. HE HAD ALREADY UNDERGONE 2 ABLATIONS IN THE PAST, AND MISSED THE DOSE OF RIVAROXABAN BEFORE THE CURRENT ABLATION. THERE WAS AN ACUTE INFARCTION IN THE RIGHT CORPUS STRIATUM AND A SMALL PUNCTUATE FOCI OF ACUTE ISCHEMIA IN THE RIGHT PREFRONTAL CORTEX ON MRI. THE PATIENT WAS TRANSITIONED FROM RIVAROXABAN TO APIXABAN AND FULLY RECOVERED AT FOLLOW-UP. 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: "IS TRANSESOPHAGEAL ECHOCARDIOGRAM MANDATORY IN PATIENTS UNDERGOING ABLATION OF ATRIAL FIBRILLATION WITH UNINTERRUPTED NOVEL ORAL ANTICOAGULANTS? RESULTS FROM A PROSPECTIVE MULTICENTER REGISTRY". THE PURPOSE OF THIS STUDY WAS TO EVALUATE WHETHER TEE IS NECESSARY BEFORE AF ABLATION IN PATIENTS TREATED WITH NOVEL ORAL ANTICOAGULANTS (NOACS). A TOTAL OF 970 PATIENTS (514 APIXABAN PATIENTS AND 456 RIVAROXABAN PATIENTS) WERE ENROLLED FOR THIS STUDY. SUSPECTED DEVICE IS THERMOCOOL SF CATHETER; HOWEVER CATALOG AND LOT NUMBER ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690556 THERMOCOOL® SF UNI-DIRECTIONAL CATHETER SIMILAR DEVICE D131601, PMA # P030031/S034 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1316-00 UNKNOWN_D-1316-00-S

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening