BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5217133 · Received November 11, 2015

    Report

    Report Number
    9673241-2015-00811
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 23, 2015
    Report Date
    October 26, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. SINCE THE LOT NUMBER IS UNKNOWN, THE FULL UDI NUMBER CANNOT BE PROVIDED. CONCOMITANT MEDICAL PRODUCTS: WEBSTER CS F-CURVE D132304, MOBICATH SHEATH D140010 LOT # W3141999, ACUNAV 8F CATHETER 10135910. (B)(4). METHODS: NO TESTING METHODS PERFORMED; RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED; CONCLUSION: DEVICE DISCARDED BY USER, UNABLE TO FOLLOW-UP. (B)(4). THE DEVICE WAS NOT RETURNED TO BWI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT ABLATION FOR AT-LEFT USING SMARTTOUCH THERMOCOOL ABLATION CATHETER AND SUFFERED CARDIAC PERFORATION DURING TRANS-SEPTAL PUNCTURE. THE PHYSICIAN MENTIONED THAT HE MAY HAVE BEEN TOO POSTERIOR DURING TRANS-SEPTAL PROCEDURE. THE PATIENT DEVELOPED POSTPROCEDURAL PERICARDIAL EFFUSION WHICH DID NOT REQUIRE SURGICAL INTERVENTION. THE PATIENT WAS REQUIRED EXTENDED HOSPITALIZATION AND DISCHARGED ONE DAY LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746930 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S UNK_D-1327-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O