BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH UNIDIRECTIONAL SF

    MDR report key: 10628014 · Received October 5, 2020

    Report

    Report Number
    2029046-2020-01388
    Event Type
    Injury
    Date Received
    October 5, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). 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 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.

    Description of Event or Problem · 1

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING COMPLICATIONS WERE REPORTED IN THIS PUBLICATION: IT WAS REPORTED THAT (B)(6) PATIENT UNDERWENT CATHETER ABLATION OF ATRIAL FIBRILLATION AND SUFFERED CORONARY ARTERY DISSECTION. INTERVENTION WAS PERCUTANEOUS CORONARY INTERVENTION. THERE ARE 0 DEATH EVENTS AND 0 DEVICE MALFUNCTIONS REPORTED IN THIS PUBLICATION. MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEVICE IS SMARTTOUCH SURROUND FLOW D/F CURVE ABLATION CATHETER OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: NONE NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: ACQMAP TECHNOLOGY, JOSEPHSON CATHETER, SL SHEATH, BRK1 NEEDLE. PUBLICATION DETAILS: TITLE: CORONARY ARTERY DISSECTION FOLLOWING RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION: CASE REPORT AND REVIEW OF THE LITERATURE. OBJECTIVE: CORONARY ARTERY INJURY FOLLOWING CATHETER ABLATION FOR CARDIAC ARRHYTHMIAS IS VERY RARE. HEREIN WE PRESENT A CASE OF CORONARY ARTERY DISSECTION FOLLOWING RF ABLATION IN A PATIENT WITHOUT PREEXISTING CORONARY ARTERY DISEASE, WHO WAS SUCCESSFULLY TREATED WITH PRIMARY PCI AND MADE A GOOD RECOVERY. WE GO ON TO DISCUSS ANATOMICAL AND PROCEDURAL ASPECTS PERTINENT TO THE MECHANISM OF INJURY, REFERENCING PREVIOUSLY REPORTED CASES AND STUDIES WHERE APPROPRIATE, TO IDENTIFY MEANS OF PREVENTING THIS FROM OCCURRING IN THE FUTURE. METHODS:(B)(6) HOSPITAL IS A HIGH-THROUGHPUT TERTIARY CARDIAC CENTER, PERFORMING MANY HUNDRED ABLATION AND CORONARY INTERVENTION PROCEDURES PER YEAR. HEREIN WE PRESENT A CASE OF CORONARY ARTERY DISSECTION FOLLOWING RF ABLATION IN A PATIENT WITHOUT PREEXISTING CORONARY ARTERY DISEASE, WHO WAS SUCCESSFULLY TREATED WITH PRIMARY PCI AND MADE A GOOD RECOVERY. WE GO ON TO DISCUSS ANATOMICAL AND PROCEDURAL ASPECTS PERTINENT TO THE MECHANISM OF INJURY, REFERENCING PREVIOUSLY REPORTED CASES AND STUDIES WHERE APPROPRIATE, TO IDENTIFY MEANS OF PREVENTING THIS FROM OCCURRING IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096565 UNK_SMART TOUCH UNIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R