BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 8694310 · Received June 13, 2019

    Report

    Report Number
    2029046-2019-03263
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON JUNE 13, 2019, IT WAS NOTED THAT "OUTCOMES ATTRIBUTED TO ADVERSE EVENT IS OTHER SERIOUS" WAS INADVERTENTLY MISSED, THEREFORE, IT HAS NOW BEEN SELECTED. ALSO, "MANUFACTURER STATE CODE" WAS INADVERTENTLY LEFT BLANK AND HAS NOW BEEN POPULATED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. MANUFACTURER'S REFERENCE : (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A SMART TOUCH UNIDIRECTIONAL CATHETER AND SUFFERED A DIAPHRAGMATIC PARALYSIS REQUIRING NO INTERVENTIONS. DURING THE PROCEDURE THE PHYSICIAN ISOLATED THE PULMONARY VEINS AND ISOLATED THE SUPERIOR VENA CAVA (SVC). THE PHYSICIAN THEN PACED FOR PHRENIC NERVE CAPTURE, AND THERE WAS NO CAPTURE. THE PHYSICIAN THEN PROCEEDED TO ISOLATE THE SVC AND CONFIRMED THE ISOLATION. THE PHYSICIAN STATED THAT THE PHRENIC NERVE WAS RESOLVED, AND THE PATIENT WAS REPORTED IN STABLE CONDITION. NO MEDICAL/SURGICAL INTERVENTION WAS PROVIDED. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE AND PATIENT¿S ANATOMY RELATED. NO BIOSENSE WEBSTER, INC. PRODUCT MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491855 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other