BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARTO® 3 SYSTEM

    MDR report key: 5494149 · Received March 10, 2016

    Report

    Report Number
    3008203003-2016-00008
    Event Type
    Death
    Date Received
    March 10, 2016
    Date of Event
    February 10, 2016
    Report Date
    March 2, 2016
    Manufacturer
    BIOSENSE WEBSTER (ISRAEL) LTD.
    Product Code
    DQK
    PMA / PMN Number
    K133916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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. CONTACT OFFICE AND MANUFACTURING SITE SHOULD REFLECT: (B)(4). MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS (B)(6) MALE. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. HOWEVER, IT WAS REPORTED THAT THE EVENT WAS RELATED TO EP MED AND NOT CARTO. MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT THE TM JUST FOUND OUT THAT ON (B)(6) 2016 THAT AFTER THE PROCEDURE A HEMATOMA AT THE GROIN ACCESS SITE. CARTO 11820, PUMP G4CP-0654 , AND GENERATOR G4C-0638. CATHETERS USED ARE UNKNOWN AND CATHETERS WERE DISPOSED OF. AN ARTERIOGRAM WAS PERFORMED ON THE ACCESS SITE BUT IT IS UNKNOWN WHAT INTERVENTIONS WERE PERFORMED. PATIENT DIED AFTER SOMETIME AFTER THE ANGIOGRAM. ISSUE IS NOT RELATED TO CARTO SYSTEM, JUST WITH VASCULAR ACCESS. UNKNOWN WHOSE SHEATH WAS USED BUT THOUGHT TO BE ST. JUDE. NO ERRORS ON EQUIPMENT. CALLER DOES NOT WANT CARTO EVALUATED. SERVICE DECLINED. THE HISTORY OF CUSTOMER COMPLAINTS ASSOCIATED WITH CARTO 3 SYSTEM # 11820 WAS REVIEWED. THERE WAS NO ANY ADDITIONAL COMPLAINT OUT OF (B)(4) ADDITIONAL REPORTED COMPLAINTS THAT MAY BE RELATED TO THE REPORTED ISSUE. DHR REVIEW WAS PERFORMED BY THE MANUFACTURER AND NO ANOMALIES WERE NOTED IN MANUFACTURING OR SERVICING OF THIS EQUIPMENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT BWI EMPLOYEE BECAME AWARE THAT ONE PATIENT SUFFERED A HEMATOMA AT THE GROIN ACCESS SITE AFTER THE PROCEDURE AND DIED ON (B)(6) 2016. NO ERRORS WITH EQUIPMENT. AN ARTERIOGRAM WAS PERFORMED ON THE ACCESS SITE BUT IT IS UNKNOWN WHAT INTERVENTIONS WERE PERFORMED. BRAND OF SHEATH WAS UNKNOWN BUT SUSPECTED TO BE ST. JUDE. PATIENT DIED SOMETIME AFTER THE ANGIOGRAM. NO FURTHER INFORMATION WAS AVAILABLE. CARTO 11820, PUMP G4CP-0654 , AND GENERATOR G4C-0638 WERE USED IN THE PROCEDURE. BRAND OF CATHETERS USED ARE UNKNOWN AND CATHETERS WERE DISPOSED. BWI TAKES CONSERVATIVE APPROACH TO REPORT THIS EVENT UNDER CARTO MAPPING SYSTEM AS BRAND OF CATHETERS OR SHEATH USED IN THIS PROCEDURE ARE UNKNOWN. SHOULD MORE INFORMATION BE RECEIVED, THIS COMPLAINT WILL BE RE-ASSESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149315 CARTO® 3 SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BIOSENSE WEBSTER (ISRAEL) LTD. M-4800-01

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death