BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6036580 · Received October 18, 2016

    Report

    Report Number
    9673241-2016-00704
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 1, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: SOUNDSTAR ECO CATHETER. PENTARAY NAV ECO CATHETER. THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN THIS REPORT IS NOT MARKETED IN THE USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS A SIMILAR DEVICE TO THE SMART TOUCH BIDIRECTIONAL CATHETER APPROVED UNDER P030031/S053. (B)(4). ARE RELATED TO THE SAME INCIDENT. EVENT DESCRIPTION CONTINUATION: IT WAS ALSO NOTED THAT THERE WERE NO ISSUES WITH THE PROCEDURAL TECHNIQUES OF PVI, BOX, AND GAP ABLATION. IT WAS CONCLUDED THAT THE INJURY OCCURRED DURING ABLATION PHASE, ALTHOUGH IT WAS NOT DIAGNOSED UNTIL SEVERAL WEEKS POST-PROCEDURE. THERE IS NO INFORMATION REGARDING TRANSSEPTAL PUNCTURE OR ANY SHEATHS USED. GENERATOR WAS SET ON POWER CONTROL MODE. THERE IS NO INFORMATION REGARDING POWER TITRATION. THERE WAS NO INFORMATION REGARDING OVERALL ABLATION TIME, LAST ABLATION CYCLE TIME AT THE SITE OF INJURY, OR IRRIGATED CATHETER FLOW SETTING. THERE IS NO INFORMATION REGARDING ANTICOAGULATION DURING THE PROCEDURE. IT HAS NOT BEEN CONFIRMED IF THE SOUNDSTAR AND PENTARAY CATHETERS WERE IN THE PATIENT¿S BODY AT THE TIME OF INJURY. THERE IS NO INFORMATION REGARDING SPI VALUE, CATHETER PROXIMITY, OR ZEROING OF THE CATHETER. THERE WERE NO ERRORS REPORTED ON ANY BWI PRODUCTS DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    ORIGINALLY, WE REPORTED THAT THE DEVICE IN THE 3500A INITIAL REPORT WAS NOT APPROVED BY THE FDA. HOWEVER, BIOSENSE WEBSTER INC. CONSIDERED IT A SIMILAR DEVICE AND WAS REPORTING THE EVENT. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI)/BOX/GAP ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A THERMOCOOL SF SMARTTOUCH BI-DIRECTIONAL CATHETER AND SUFFERED AN AIR EMBOLISM AND AN ESOPHAGEAL FISTULA (REQUIRING SURGICAL INTERVENTION). PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. AT SOME POINT, POST-DISCHARGE, THE PATIENT RETURNED TO THE HOSPITAL WITH ANOREXIA AND HEADACHE. COMPUTED TOMOGRAPHY CONFIRMED AN AIR EMBOLISM. FURTHER EVALUATION REVEALED AN ATRIO-ESOPHAGEAL FISTULA NEAR THE ABLATION SITE. GASTRIC DILATATION DID NOT RESULT IN HEMATEMESIS. TWENTY DAYS POST-PROCEDURE, A SURGICAL REPAIR OF THE FISTULA WAS PERFORMED. THE SURGEON INDICATED THAT THERE WAS A SIGNIFICANT ADHESION BETWEEN THE LEFT ATRIUM AND THE ESOPHAGUS. THE PATIENT WAS EVALUATED IN THE INTENSIVE CARE UNIT. PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT. THERE IS NO INFORMATION REGARDING PATIENT OUTCOME. THERE WERE NO FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. ALTHOUGH THE PHYSICIAN INDICATED THAT THE CAUSE OF THE ADVERSE EVENT WAS PROCEDURE-RELATED AND THAT THERE WERE NO BWI PRODUCT MALFUNCTIONS OBSERVED, HE COULD NOT BE CERTAIN IF THERE WAS AN ASSOCIATION BETWEEN THE ADVERSE EVENT AND THE THERMOCOOL SF SMARTTOUCH BI-DIRECTIONAL CATHETER. THE PHYSICIAN INDICATED THAT GIVEN THE INFORMATION IN THE EUROPACE ARTICLE, "IMPACT OF SURROUND FLOW CATHETER TIP IRRIGATION IN CONTACT FORCE ABLATION ON THE INCIDENCE OF ASYMPTOMATIC OESOPHAGEAL LESIONS AFTER ATRIAL FIBRILLATION ABLATION: A PROSPECTIVE COMPARATIVE STUDY", HE MAY RECONSIDER HIS USAGE OF THE THERMOCOOL SF SMARTTOUCH BI-DIRECTIONAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689242 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R