BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 5039185 · Received August 28, 2015

    Report

    Report Number
    9673241-2015-00571
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 4, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. AS LOT # 17115595L WAS PROVIDED, THE DEVICE HISTORY RECORD(S) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. BWI CONCOMITANT PRODUCTS USED: PRODUCT NAME: LASSO NAV ECO VARIABLE CATHETER, US CATALOG #: D134301, SERIAL #: (B)(4). PRODUCT NAME: WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID, US CATALOG #: BD710FJ282CT, SERIAL #: (B)(4). (B)(4) THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL SMART TOUCH BI-DIRECTIONAL NAVIGATION CATHETER APPROVED UNDER P030031/S053. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT, UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF BI-DIRECTIONAL NAV CATHETER AND EXPERIENCED VASCULAR COMPLICATION AT THE PUNCTURE SITE WHICH REQUIRED HOSPITALIZATION. APPROXIMATELY 15 DAYS AFTER THE PROCEDURE, WHEN SHE WAS GOING TO BE DISCHARGE FROM THE HOSPITAL, PATIENT SUFFERED RETROSTERNAL PAIN WHICH REQUIRED COMPUTED TOMOGRAPHY SCANNING AND AN ATRIOESOPHAGEAL FISTULA WAS DIAGNOSED REQUIRING SURGICAL INTERVENTION AS WELL AS EXTENDED HOSPITALIZATION. FOLLOW UP INVESTIGATION WAS PERFORMED TO CLARIFY THE EVENT AND IT WAS INFORMED THAT COMPLICATION AT PUNCTURE SITE WAS A TEAR OF THE INTERNAL ILIAC VEIN WHICH REQUIRED STITCHES. FURTHERMORE, PATIENT ALSO EXPERIENCED PLEURAL EFFUSION, CARDIAC PERIDECTOMY SYNDROME AS WELL AS GASTROPARESIS REQUIRING RIGHT AND LEFT PLEURAL DRAINAGE, ANTI-INFLAMMATORY MEDICATION AND DIGESTIVE CATHETER FEEDING, RESPECTIVELY. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT WAS REPORTED TO BE RECOVERED AT THE TIME BWI FOLLOWED-UP. THE PHYSICIAN'S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THEY DAMAGED THE INTERNAL ILIAC VEIN WITH THE J GUIDE WIRE AT THE VERY BEGINNING WHEN THEY INSERTED THE WIRE DURING THE ACCESS PUNCTURE. ABLATION WAS CONDUCTED AT LOW POWER (20 WATTS) FOR 5 MINUTES IN THE LEFT POSTERIOR WALL AND 3 MINUTES IN THE RIGHT POSTERIOR WALL. NEVERTHELESS, THIS EVENT IS BEING REPORTED CONSERVATIVELY SINCE WE CANNOT RULE OUT THAT THE BWI CATHETER MAY HAVE BEEN INVOLVED IN THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572245 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17115595L

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R