BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3121269 · Received May 20, 2013

    Report

    Report Number
    9673241-2013-00168
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION WILL NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: CARTO 3 SYSTEM: MODEL #: M-4800-01, SERIAL #: (B)(4). STOCKERT 70 SYSTEM: MODEL #: M-5463-01, SERIAL #: (B)(4). COOLFLOW PUMP: MODEL #: M-5491-02, SERIAL #: (B)(4). SOUNDSTAR CATHETER: MODEL #: M-5723-05, LOT #: OEM_M-5723-05. DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. LASSO SAS CATHETER: MODEL #: D-1312-01-S, LOT #: 15801343L. DEVICE EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. NON BWI - AGILIS SHEATH. REGARDING THE BIOSENSE WEBSTER SYSTEMS, THE CUSTOMER WAS CONTACTED BY BWI FIELD REPRESENTATIVE. THE HOSPITAL EP LAB STAFF ADVISED THAT THIS ISSUE WAS NOT RELATED TO BWI SYSTEMS. THE CUSTOMER DECLINED SYSTEM SERVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    IN SUPPLEMENTAL FOLLOW-UP #1 (B)(4) 2013, REPORTED THAT THE PRODUCT INVESTIGATION WOULD NOT BE PERFORMED SINCE THE CATHETER WAS NOT RETURNED FOR ANALYSIS. HOWEVER, ON (B)(4) 2013 THE BWI FAILURE ANALYSIS LAB RECEIVED THE PRODUCT AND HAS ANALYZED. (B)(4). IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT HAD A DROP IN PRESSURE AND A POSSIBLE PERFORATION. AT THE TIME OF THE CALL, NO ADDITIONAL DETAILS COULD BE PROVIDED. UPON RECEIPT, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THIS EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION WAS THAT IT WAS RELATED TO THE ABLATION. THE ONLY OTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE PERFORATION ACCORDING TO THE PHYSICIAN WAS THAT HE HAD A CHALLENGING RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PHYSICIAN DID NOT HAVE ANY DIFFICULTY IN MANIPULATING THE CATHETER PRIOR TO THE EVENT. THERE WERE MORE THAN 15 ABLATION APPLICATIONS DELIVERED TO THE PATIENT BEFORE THE EVENT. THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE LEFT INFERIOR PULMONARY VEIN (LIPV) WERE COMPLETED. THEY WERE MORE THAN HALFWAY THROUGH THE (RSPV). THE RF GENERATOR WAS SET TO ¿POWER-CONTROL¿ MODE AT 35 W. THE TEMPERATURE CUT OFF SETTING WAS SET TO 50 W AND THE FLOW SETTING WAS SET TO 30 W. THE AGILIS SHEATH WAS USED WITH THE EZ STEER THERMOCOOL NAVIGATIONAL 4MM CATHETER. THE ACT WAS MAINTAINED AT 300-350. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND IT WAS FOUND IN NORMAL CONDITIONS. PER THE EVENT, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND STOCKERT COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. FURTHERMORE, AN IRRIGATION TEST WAS PERFORMED AND THE CATHETER PASSED, NO OCCLUSION WAS OBSERVED. THE CATHETER WAS ALSO EVALUATED FOR EEPROM, CARTO 3, 4 KHZ AND CALIBRATION FUNCTIONALITY. THE CATHETER WAS RECOGNIZED BY CARTO 3 SYSTEM, NO ERROR MESSAGES WERE DISPLAYED AND THE CATHETER WAS PROPERLY VISUALIZED. EEPROM DATA DEMONSTRATES THE CATHETER WAS PROPERLY CALIBRATED DURING MANUFACTURING. FINALLY, A DEFLECTION TEST WAS PERFORMED AND THE CATHETER PASSED. 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 PERFORATION REMAINS UNKNOWN. THE IFU STATES 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 DURING AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT HAD A DROP IN PRESSURE AND A POSSIBLE PERFORATION. AT THE TIME OF THE CALL, NO ADDITIONAL DETAILS COULD BE PROVIDED. UPON RECEIPT, THE BWI FIELD REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION ON THE EVENT. THIS EVENT OCCURRED DURING THE ABLATION PHASE. THE PHYSICIAN¿S OPINION REGARDING THE CAUSALITY OF THE PERFORATION WAS THAT IT WAS RELATED TO THE ABLATION. THE ONLY OTHER FACTOR THAT MIGHT HAVE CONTRIBUTED TO THE PERFORATION ACCORDING TO THE PHYSICIAN WAS THAT HE HAD A CHALLENGING RIGHT SUPERIOR PULMONARY VEIN (RSPV). THE PHYSICIAN DID NOT HAVE ANY DIFFICULTY IN MANIPULATING THE CATHETER PRIOR TO THE EVENT. THERE WERE MORE THAN 15 ABLATION APPLICATIONS DELIVERED TO THE PATIENT BEFORE THE EVENT. THE LEFT SUPERIOR PULMONARY VEIN (LSPV) AND THE LEFT INFERIOR PULMONARY VEIN (LIPV) WERE COMPLETED. THEY WERE MORE THAN HALFWAY THROUGH THE (RSPV). THE RF GENERATOR WAS SET TO ¿POWER-CONTROL¿ MODE AT 35 W. THE TEMPERATURE CUT OFF SETTING WAS SET TO 50 W AND THE FLOW SETTING WAS SET TO 30 W. THE AGILIS SHEATH WAS USED WITH THE EZ STEER THERMOCOOL NAVIGATIONAL 4MM CATHETER. THE ACT WAS MAINTAINED AT 300-350.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222324 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15797409M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening