BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 7680206 · Received July 11, 2018

    Report

    Report Number
    2029046-2018-01788
    Event Type
    Death
    Date Received
    July 11, 2018
    Date of Event
    June 14, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD, MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED ON JULY 13, 2018 THEREFORE, EXPIRATION DATE AND MANUFACTURED DATE HAVE BEEN POPULATED. THE DEVICE HISTORY RECORD (DHR) FOR THE LOT NUMBER 17755520L HAS BEEN REVIEWED AND IT WAS VERIFIED THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES. (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2018. IT WAS DISCOVERED ON (B)(6) 2018 THAT THERE WAS A KINK FOUND ON CATHETER SHAFT AT APPROXIMATELY 5.5 CM FROM THE CATHETER HANDLE. NO OTHER VISUAL DAMAGES WERE FOUND. THIS RETURNED CONDITION WAS ASSESSED AS NOT REPORTABLE SINCE THE DEVICE INTEGRITY WAS MAINTAINED AND NO INTERNAL COMPONENTS WERE EXPOSED. THE POTENTIAL RISK THAT IT COULD CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. AFTER FURTHER REVIEW, IT WAS ASSESSED TO ADD THE PATIENT CODE (B)(4). THEREFORE, PATIENT CODES HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: IT WAS REPORTED THAT A MALE PATIENT, APPROXIMATELY 60 YEARS OF AGE, UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. LEFT VENTRICULAR ACCESS WAS OBTAINED VIA RETROGRADE AORTIC APPROACH USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. MAPPING WAS PERFORMED FOR APPROXIMATELY 30 MINUTES. ACTIVATION MAPPING WAS PERFORMED FOR 45 MINUTES DURING TACHYCARDIA. SOUNDSTAR CATHETER AND CARTOSOUND WERE IN USE. BLOOD PRESSURE WAS REPORTED TO BE STABLE. AFTER MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PHYSICIAN PROCEEDED TO MAP USING THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER. AFTER APPROXIMATELY 7 MINUTES, THE PATIENT WENT INTO SINUS RHYTHM. PHYSICIAN REMOVED THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND RESUMED MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER IN ORDER TO CREATE A BIPOLAR MAP DURING SINUS RHYTHM. THE LEFT VENTRICLE WAS ACCESSED USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. AFTER APPROXIMATELY 10 MINUTES OF BIPOLAR MAPPING, THE PATIENT BECAME HYPOTENSIVE AND THE STRENGTH OF CONTRACTIONS WAS REDUCED. RESUSCITATIVE MANEUVERS (UNSPECIFIED) WERE PERFORMED WHILE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS IN THE RIGHT VENTRICLE, SOUNDSTAR CATHETER WAS IN THE RIGHT ATRIUM, AND THE TETRAPOLAR CATHETER WAS IN THE RIGHT VENTRICLE. SOUNDSTAR CATHETER RULED OUT PERICARDIAL EFFUSION. CORONARY ANGIOGRAPHY REVEALED A LEFT CORONARY ARTERY TRUNK OBSTRUCTION. VASCULAR OBSTRUCTION WAS RESOLVED VIA CORONARY ANGIOPLASTY. PATIENT EXPIRED AT APPROXIMATELY MIDNIGHT. IT WAS NOTED THAT NO ABLATION WAS PERFORMED. THE DEVICE WAS VISUALLY INSPECTED AND A KINK WAS OBSERVED ON THE SHAFT. THE MAGNETIC SENSOR WAS TESTED ON CARTO AND THE CATHETER WAS PROPERLY VISUALIZED AND NO ERRORS WERE OBSERVED. THEN, THE FORCE SENSOR WAS TESTED AND IT WAS WORKING PROPERLY, THE FORCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, ELECTRICAL TEST WAS PERFORMED ON THE CATHETER AND IT WAS FOUND WITHIN SPECIFICATIONS. NO ELECTRICAL MALFUNCTION WAS OBSERVED. ADDITIONALLY, THE CATHETER WAS TESTED ON THE GENERATOR AND THE TEMPERATURE AND IMPEDANCE VALUES WERE OBSERVED WITHIN SPECIFICATIONS. THEN, THE IRRIGATION AND DEFLECTION TEST WERE PERFORMED AND IT WAS FOUND WITHIN SPECIFICATIONS, THE CATHETER WAS IRRIGATING AND DEFLECTING CORRECTLY. THE DEVICE HISTORY RECORD (DHR) 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. THE CATHETER PASSED ALL SPECIFICATIONS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE. THE ROOT CAUSE OF THE BENT ON THE SHAFT COULD BE RELATED TO THE HANDLING OF THE DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS. 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. THEREFORE, REASON FOR NON- EVALUATION HAS BEEN UPDATED. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    STILL PENDING IS THE MANUFACTURED DATE AND THE EXPIRATION DATE. THEREFORE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO UPDATE THE. EXPIRATION DATE AND MANUFACTURED DATE. CONCOMITANT PRODUCTS: SOUNDSTAR, US CATALOG #: SNDSTR10G, LOT #: UNKNOWN. PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, US CATALOG #: D128208, LOT #: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT, APPROXIMATELY 60 YEARS OF AGE, UNDERWENT AN ABLATION PROCEDURE FOR ISCHEMIC VENTRICULAR TACHYCARDIA WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CORONARY ARTERY STENOSIS (REQUIRING SURGICAL INTERVENTION) AND DEATH. LEFT VENTRICULAR ACCESS WAS OBTAINED VIA RETROGRADE AORTIC APPROACH USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. MAPPING WAS PERFORMED FOR APPROXIMATELY 30 MINUTES. ACTIVATION MAPPING WAS PERFORMED FOR 45 MINUTES DURING TACHYCARDIA. SOUNDSTAR CATHETER AND CARTOSOUND WERE IN USE. BLOOD PRESSURE WAS REPORTED TO BE STABLE. AFTER MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PHYSICIAN PROCEEDED TO MAP USING THE SMART TOUCH UNIDIRECTIONAL SF CATHETER. AFTER APPROXIMATELY 7 MINUTES, THE PATIENT WENT INTO SINUS RHYTHM. PHYSICIAN REMOVED THE SMART TOUCH UNIDIRECTIONAL SF CATHETER AND RESUMED MAPPING WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER IN ORDER TO CREATE A BIPOLAR MAP DURING SINUS RHYTHM. THE LEFT VENTRICLE WAS ACCESSED USING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. AFTER APPROXIMATELY 10 MINUTES OF BIPOLAR MAPPING, THE PATIENT BECAME HYPOTENSIVE AND THE STRENGTH OF CONTRACTIONS WAS REDUCED. RESUSCITATIVE MANEUVERS (UNSPECIFIED) WERE PERFORMED WHILE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS IN THE RIGHT VENTRICLE, SOUNDSTAR CATHETER WAS IN THE RIGHT ATRIUM, AND THE TETRAPOLAR CATHETER WAS IN THE RIGHT VENTRICLE. SOUNDSTAR CATHETER RULED OUT PERICARDIAL EFFUSION. CORONARY ANGIOGRAPHY REVEALED A LEFT CORONARY ARTERY TRUNK OBSTRUCTION. VASCULAR OBSTRUCTION WAS RESOLVED VIA CORONARY ANGIOPLASTY. PATIENT EXPIRED AT APPROXIMATELY MIDNIGHT. IT WAS NOTED THAT NO ABLATION WAS PERFORMED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE PATIENT¿S CONDITION. THERE IS NO AUTOPSY INFORMATION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION REGARDING THE PATIENT¿S DEATH. FORCE VISUALIZATION FEATURES INCLUDED DASHBOARD AND VECTOR. VISITAG MODULE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518656 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 17755520L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R