BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO 3 SYSTEM

    MDR report key: 11516936 · Received March 18, 2021

    Report

    Report Number
    2029046-2021-00381
    Event Type
    Injury
    Date Received
    March 18, 2021
    Date of Event
    February 19, 2021
    Report Date
    February 19, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DQK
    UDI-DI
    10846835000870
    PMA / PMN Number
    K133916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE COMPLETED MRE, THE H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED WITH 12/13/2009. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) -PERSISTENT ABLATION PROCEDURE WITH A CARTO 3 SYSTEM. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND A TRANSSEPTAL PUNCTURE HAD BEEN MADE WHEN THE CASE WAS CANCELLED DUE TO FAILURE OF THE CARTO 3 SYSTEM. DURING THE PROCEDURE, MAP 1-2 WAS DAMAGED, AND EVERY TIME THE CATHETER WAS PLUGGED IN, EVERYTHING WOULD SHUT DOWN, WITH NO SIGNAL OR NOISE ON EVERY SIGNAL CATHETER. AN ANESTHESIA MONITOR WAS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM (ECG SIGNAL). THE PROCEDURE COULD NOT BE FINISHED. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS AND NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS WAS A BIOSENSE WEBSTER, INC. (BWI) PRODUCT MALFUNCTION WHERE MAP 1-2 PORT (BACK PLANE) WAS DAMAGED. DEVICE EVALUATION DETAILS: THE BWI FIELD SERVICE ENGINEER (FSE), WHILE ON SITE, CONFIRMED A PHYSICALLY DAMAGED MAP PORT LOCATED ON THE BACKPLANE CARD. THE FSE REPLACED THE DAMAGED BACKPLANE CARD WITH A NEW ONE. PM/ATP TESTS WERE PERFORMED AFTER BACKPLANE CARD REPLACEMENT. ALL TESTS PASSED AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS IN SERVICE AND READY FOR USE. THE BACKPLANE CARD HTC RMA INVESTIGATION CANNOT BE PERFORMED DUE TO DAMAGED BACKPLANE CARD WAS SCRAPPED IN THE EMEA QUEST WAREHOUSE. THE HISTORY OF CUSTOMER COMPLAINTS REPORTED DURING THE LAST YEAR ASSOCIATED WITH CARTO 3 SYSTEM # 10233 WAS REVIEWED. NO SIMILAR COMPLAINTS WERE FOUND. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE CARTO 3 SYSTEM # 10233, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(6) ON 5/27/2021, DURING AN INTERNAL REVIEW OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE REPORTED EVENT OF "ABSENCE OF TREATMENT" IS TO BE CONSIDERED A NON-SERIOUS PATIENT EVENT AND NOT MDR REPORTABLE SINCE THE PHYSICIAN DID NOT CONSIDER THAT CANCELLING THE PROCEDURE (ABSENCE OF TREATMENT) REPRESENTED AN INCREASED RISK TO THE PATIENT. THERE WAS NO EXACERBATION OF PATIENT¿S DISEASE. NO ADDITIONAL INTERVENTION NOR PROLONGED HOSPITALIZATION WERE REQUIRED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) -PERSISTENT ABLATION PROCEDURE WITH A CARTO 3 SYSTEM. THE PATIENT WAS UNDER GENERAL ANESTHESIA AND A TRANSSEPTAL PUNCTURE HAD BEEN MADE WHEN THE CASE WAS CANCELLED DUE TO FAILURE OF THE CARTO 3 SYSTEM. DURING THE PROCEDURE, MAP 1-2 WAS DAMAGED, AND EVERY TIME THE CATHETER WAS PLUGGED IN, EVERYTHING WOULD SHUT DOWN, WITH NO SIGNAL OR NOISE ON EVERY SIGNAL CATHETER. AN ANESTHESIA MONITOR WAS AVAILABLE TO MONITOR THE PATIENT¿S HEART RHYTHM (ECG SIGNAL). THE PROCEDURE COULD NOT BE FINISHED. THE PATIENT FULLY RECOVERED WITH NO RESIDUAL EFFECTS AND NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS WAS A BIOSENSE WEBSTER, INC. (BWI) PRODUCT MALFUNCTION WHERE MAP 1-2 PORT (BACK PLANE) WAS DAMAGED. THE BWI FIELD SERVICE ENGINEER, WHILE ON SITE, DISCOVERED A PHYSICALLY DAMAGED SHORT LOCATION PAD CABLE. THE CABLE AND BACKPLANE CARD WAS REPLACED. ALSO, 2 PIN BOXES HAD BENT PINS INSIDE THE CONNECTOR. SINCE THE EVENT IS LIFE THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, THEN IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411723 CARTO 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER INC FG540000 10846835000870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN BRAND CATHETER| UNKNOWN BRAND CATHETER