BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL

    MDR report key: 11606473 · Received April 1, 2021

    Report

    Report Number
    2029046-2021-00486
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    December 31, 2014
    Report Date
    March 23, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REPORT NUMBER: 2029046-2021-00487 IS RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATION WAS REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT 1 PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED A PSEUDOANEURYSM IN THE GROIN, THIS EVENT REQUIRED ULTRASOUND GUIDED COMPRESSION WHICH PROLONGED THE HOSPITAL STAY ONE DAY. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS SMARTTOUCHTM THERMOCOOL. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: LASSO, CARTO 3 NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: PRUCKA CARDIOLABTM, EP SHUTTLE ST-3077. PUBLICATION DETAILS: TITLE: REPEAT PULMONARY VEIN ISOLATION IN PATIENTS WITH ATRIAL FIBRILLATION: LOW ABLATION INDEX IS ASSOCIATED WITH INCREASED RISK OF RECURRENT ARRHYTHMIA. OBJECTIVE: WE AIMED TO INVESTIGATE THE PREDICTORS OF RECURRENT ARRHYTHMIA AFTER REPEATED PULMONARY VEIN ISOLATION (PVI) PERFORMED IN THE ERA OF CONTACT FORCE WITHOUT ADDITIONAL SUBSTRATE ABLATION. ONE OF THE PREDICTORS STUDIED, ABLATION INDEX (AI), INCORPORATES POWER, CONTACT FORCE, AND TIME IN A WEIGHTED FORMULA AND IS REPORTED TO PREDICT LESION SIZE IN ANIMALS. METHODS: CONSECUTIVE PATIENTS (N ¼ 108) UNDERGOING REPEAT PVI WITHOUT ADDITIONAL SUBSTRATE MODIFICATION USING A CONTACT FORCE SENSING CATHETER WERE INCLUDED RETROSPECTIVELY AT A TERTIARY CENTER. ALL ABLATION POINTS WERE ANALYZED OFFLINE. A NEW VARIABLE, NORMALIZED AI (AI CORRECTED FOR THE LOCATION OF THE LESION¿ANTERIOR VS. POSTERIOR) WAS CALCULATED. THE PATIENTS WERE SYSTEMATICALLY FOLLOWED WITH CLINICAL VISIT AND 12-LEAD ECG AS WELL AS REVIEW OF THE REGIONAL ELECTRONIC PATIENT FILES AT 3 AND 12 MONTHS AFTER THE PROCEDURE WITH 5-DAY HOLTER AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501897 UNK_SMART TOUCH BIDIRECTIONAL SIMILAR DEVICE D132701, PMA # P030031/S053 OAD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization EP SHUTTLE ST-3077| PRUCKA CARDIOLABTM| UNK_CARTO 3| UNK_LASSO