BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 5917610 · Received August 31, 2016

    Report

    Report Number
    9673241-2016-00540
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 9, 2016
    Report Date
    August 9, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009019
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 8/31/2016, THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    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. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, MODEL # M-4800-01, S/N: (B)(4); SMARTABLATE GENERATOR (1 OF 2), MODEL # M-4900-07, S/N: (B)(4); SMARTABLATE GENERATOR (2 OF 2), MODEL # M-4900-07, S/N: (B)(4); TWO (2) EZ STEER NAVIGATIONAL CATHETERS, MODEL # D-1260-04-S, LOT # 17419131M. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. THE RETURNED DEVICE WAS VISUALLY INSPECTED AND WAS FOUND IN GOOD CONDITION. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND A GENERATOR TEST. THE CATHETER WAS FOUND WITHIN SPECIFICATIONS. A DEFLECTION TEST WAS PERFORMED, WHICH THE CATHETER PASSED. THE CATHETER WAS EVALUATED FOR EEPROM AND SENSOR FUNCTIONALITY ON THE CARTO SYSTEM. THE CATHETER WAS RECOGNIZED BY THE CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. THE FORCE FEATURE WAS EVALUATED AND PASSED. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER PASSED; NO OCCLUSION WAS OBSERVED. 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 TAMPONADE REMAINS UNKNOWN. THE INSTRUCTIONS FOR USE STATE THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION OR TAMPONADE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) WITH A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, THE SMARTABLATE GENERATOR WOULD NOT DISPLAY IMPEDANCE FOR THE TWO (2) 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS. THE CABLES WERE REPLACED, GENERATOR WAS RE-BOOTED, GENERATOR WAS EXCHANGED, AND PACE ROUTING WAS CONFIRMED TO BE DISABLED WITHOUT SUCCESS. THE 8MM NAVIGATIONAL BI-DIRECTIONAL CATHETERS WERE EXCHANGED FOR A THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL CATHETER. THE SMARTABLATE GENERATOR INITIALLY DID NOT DISPLAY IMPEDANCE FOR THE SMARTTOUCH. THE CATHETER CONNECTOR WAS RE-SEATED INTO THE GENERATOR AND THE ISSUE WAS RESOLVED. DURING MAPPING WITH THE SMARTTOUCH CATHETER, THE PATIENT BECAME HYPOTENSIVE AND TAMPONADE WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM. PERICARDIOCENTESIS YIELDED 150-200CC. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568971 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-03-S 17464981M 10846835009019

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R