BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® NAV ECO VARIABLE CATHETER

    MDR report key: 13538823 · Received February 15, 2022

    Report

    Report Number
    2029046-2022-00306
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 19, 2022
    Report Date
    May 6, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009637
    PMA / PMN Number
    K113213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 17-FEB-2022. DRAINAGE WAS NOT PERFORMED FOR PERICARDIAL EFFUSION. PRIOR TO NOTING THE PERICARDIAL EFFUSION, ABLATION WAS PERFORMED. THERE WAS NO EVIDENCE OF A STEAM POP. THIS EVENT OCCURRED DURING THE MAPPING PHASE. AS FAR AS AN ADVERSE EVENT, THE PATIENT HAD NO PROBLEM AT THAT TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION REGARDING THE EVENT OF THE PERICARDIAL EFFUSION AS IT IS UNCLEAR IF THE PATIENT SUFFERRED THIS ISSUE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, PERICARDIAL EFFUSION WILL BE CONSERVATIVELY CODED UNDER H6. HEALTH EFFECT - CLINICAL CODE. THE PERICARDIAL EFFUSION WAS ASSESSED AS NOT REPORTABLE AS IT IS PATIENT EVENT NON SERIOUS. ADDITIONAL INFORMATION WAS RECEIVED ON 03-MAR-2022. A TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A 71 CM LIFELINE NEEDLE. AN IRRIGATED CATHETER WAS USED IN THE EVENT, THE FLOW SETTING WAS AS USUAL. ADDITIONAL INFORMATION WAS RECEIVED ON 03-MAR-2022: AN ABLATION CATHETER WAS INSERTED THROUGH THE CAROTID ARTERY TO REMOVE THE STUCK LASSO. THERE WERE NO BLEEDING ISSUES. CLARIFICATION FOR WORD DORMANT USED PROVIDED BY BWI SALES CONSULTANT, THEY STATE IT MEANS TO CHECK IF SVC QUARANTINE IS COMPLETED. PER THE ADDITIONAL INFORMATION RECEIVED, UPDATED THE ¿D10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES¿ FIELD. THE INVESTIGATION WAS COMPLETED ON 01-MAR-2022. INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30623841L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER:(B)(4). DURING AN INTERNAL REVIEW ON 11-MAR-2022, NOTED A CORRECTION TO 3500A INITIAL. IN THE ¿H10. ADDITIONAL MANUFACTURER NARRATIVE¿ IT WAS REPORTED, ¿MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER.¿ IT SHOULD HAVE STATED, ¿INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED.¿

    Additional Manufacturer Narrative · 0

    IN THE 3500A FOLLOW-UP #1, IT WAS REPORTED, "MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION REGARDING THE EVENT OF THE PERICARDIAL EFFUSION AS IT IS UNCLEAR IF THE PATIENT SUFFERED THIS ISSUE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THEREFORE, PERICARDIAL EFFUSION WILL BE CONSERVATIVELY CODED UNDER H6. HEALTH EFFECT - CLINICAL CODE. THE PERICARDIAL EFFUSION WAS ASSESSED AS NOT REPORTABLE AS IT IS PATIENT EVENT NON SERIOUS." ADDITIONAL INFORMATION WAS RECEIVED ON 12-APRIL 12, 2022 CLARIFYING A PERICARDIAL EFFUSION WAS NOT REPORTED. THEREFORE, REMOVED THE H6. HEALTH EFFECT - CLINICAL CODE OF "PERICARDIAL EFFUSION". ADDED H6. HEALTH EFFECT - CLINICAL CODE OF "UNSPECIFIED TISSUE INJURY (E2015)" CODE. IN ADDITION, REMOVED H6. HEALTH EFFECT - IMPACT CODE OF "RECOGNISED DEVICE OR PROCEDURAL COMPLICATION (F15)" CODE. 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 · 0

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. THE LASSO® NAV ECO VARIABLE CATHETER BECAME STUCK IN THE CHIARI NETWORK REQUIRING INTERVENTION AS THE ABLATION CATHETER WAS INSERTED FROM THE JUGULAR VEIN AND PLACED ON THE RING TO HELP RELEASE THE LASSO® NAV ECO VARIABLE CATHETER. THE RING PART WAS CAUGHT IN CHIARI NETWORK. THIS OCCURRED AFTER SUPERIOR VENA CAVA (SVC) ISOLATION WHEN MOVED UP TO THE SVC TO CHECK THE DORMANT CONDUCTION. THE CAUSALITY WITH THE PRODUCT WAS UNKNOWN. IT MIGHT HAVE BEEN CAUGHT IN RAISING THE LASSO® NAV ECO VARIABLE CATHETER FROM RIGHT ATRIUM (RA) TO SVC. AN ABLATION CATHETER WAS INSERTED FROM THE JUGULAR VEIN AND PLACED ON THE RING. THE RING OF LASSO® NAV ECO VARIABLE CATHETER WAS SEPARATED FROM THE CHIARI NETWORK. SVC DORMANT CONDUCTION WAS NOT CONFIRMED AND WAS TERMINATED. IT WAS REMOVED PERCUTANEOUSLY FROM THE ROUTE PREVIOUSLY SECURED IN THE CAROTID ARTERY. THIS ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. PATIENT OUTCOME WAS REPORTED AS NO RESIDUAL EFFECTS. AFTER THE PROCEDURE, AN ECHO WAS PERFORMED, THERE WAS NO PERICARDIAL EFFUSION, THERE WAS NO PROBLEM AT THE MOMENT, BUT IF BLEEDING OCCURRED LITTLE BY LITTLE, DRAINAGE MAY BE PERFORMED. THE PATIENT'S CURRENT STATUS IS UNKNOWN AND THE PROLONGED HOSPITALIZATION IS ALSO UNKNOWN. THE CAUSALITY WITH THE PRODUCT WAS UNKNOWN, AND IT MIGHT HAVE BEEN CAUGHT IN RAISING THE LASSO® NAV ECO VARIABLE CATHETER FROM RA TO SVC. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. BASED ON THE AVAILABLE INFORMATION THAT THE ABLATION CATHETER WAS INSERTED FROM THE JUGULAR VEIN AND PLACED ON THE RING TO HELP RELEASE THE LASSO® NAV ECO VARIABLE CATHETER, THIS EVENT WILL BE CONSERVATIVELY REPORTED AS AN ADVERSE EVENT AND A MALFUNCTION. SINCE THE SURGICAL INTERVENTION IS REQUIRED OR A SERIOUS INJURY OCCURRED, THE EVENT IS REPORTABLE. THE MEDICAL DEVICE ENTRAPMENT DESCRIBED IN THIS EVENT WAS ASSESSED AS A MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528689 LASSO® NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC D134301 30623841L 10846835009637

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Required Intervention NON BWI-71 CM LIFELINE NEEDLE.| UNKNOWN BRAND ABLATION CATHETER.