BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER

    MDR report key: 16687432 · Received April 6, 2023

    Report

    Report Number
    2029046-2023-00737
    Event Type
    Injury
    Date Received
    April 6, 2023
    Date of Event
    March 9, 2023
    Report Date
    May 8, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OBJ
    UDI-DI
    10846835008869
    PMA / PMN Number
    K140318
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-00736 FOR PRODUCT CODE D134801 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). FOR PRODUCT CODE 10439236 (SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 12-APR-2023. IT WAS REPORTED THAT THE OUTCOME OF THE ADVERSE EVENT IS IMPROVED. PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT. ON 24-APR-2023, DURING AN INTERNAL REVIEW, IT WAS NOTED THAT THE HEART BLOCK IS ASSOCIATED WITH THE ABLATION CATHETER (STSF CATHETER) AS THE EVENT STATED THAT THE BLOCK OCCURRED DURING ABLATION. THE SOUNDSTAR HAD A RECOGNITION ISSUE AND IS NOT A CONTRIBUTOR TO THE HEART BLOCK. AS SUCH, THIS EVENT HAS BEEN REASSESSED AND IS NO LONGER CONSIDERED TO BE MDR REPORTABLE AGAINST THE SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER. THE H6. HEALTH EFFECT - CLINICAL CODE, H6. HEALTH EFFECT - IMPACT CODE AND H6. MEDICAL DEVICE PROBLEM CODE HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-00736 FOR PRODUCT CODE D134801 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). (2) MFR # 2029046-2023-00737 FOR PRODUCT CODE 10439236 (SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL CATHETER (STSF) AND SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER AND EXPERIENCED A HEART BLOCK ATRIOVENTRICULAR (AV). IT WAS REPORTED THAT THE PROBE WAS NOT RECOGNIZED ON THE ECHO (S70). TIMING WHEN COMPLAINTS OCCURRED WAS WHEN THE CATHETER WAS CONNECTED. THE CATHETER AND THE CABLE WERE RECONNECTED IN ACCORDANCE WITH THE CONNECTION PROCEDURE, BUT THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN CONFIRMED THAT THE PROBE WAS ABLE TO BE RECOGNIZED WITH THE TEST CATHETER. BECAUSE THE ISSUE WAS RESOLVED WITH THE SOUNDSTAR ECO CATHETER REPLACEMENT, THE PROCEDURE WAS CONTINUED AND COMPLETED. ADVERSE EVENT: AV CONDUCTION DISORDER. THIS EVENT OCCURRED DURING ABLATION WITH STSF FROM LEFT ATRIUM (LA) FOR SEPTAL ATRIAL TACHYCARDIA (AT) NEAR HIS. AV INTERVAL WAS 324 MSC WITH A PAGING RATE OF 140. WENCKEBACH AT 160, AND 2:1 BLOCK AT 180. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE IS NO RELATIONSHIP WITH THE PRODUCT. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. A SMART ABLATE GENERATOR WAS USED. PRODUCT CODE IS M4900207. SERIAL NUMBER IS (B)(4). NO ADDITIONAL MEDICAL INTERVENTION AND EXTENSION OF HOSPITALIZATION. THE PATIENT¿S STATE IS RECOVERING. RELEVANT MEDICAL HISTORY: NONE. ALLERGIES, SMOKING, ETC.: NONE. RELEVANT TESTS/LABORATORY DATA: NO PQ PROLONGATION ON THE 12-LEAD ECG AFTER THE PROCEDURE. THE ULTRASOUND RECOGNITION ISSUE IS NOT MDR REPORTABLE. THE INCIDENCE OF ¿CATHETER/ULTRASOUND RECOGNITION ISSUE¿ IS EASILY DETECTABLE BY THE USER. THIS HAS EITHER NO OR LOW IMPACT TO PATIENT SAFETY. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820304 SOUNDSTAR ECO 8FG ULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER CATHETER, ULTRASOUND, INTRAVASCULAR OBJ BIOSENSE WEBSTER INC 10439236 G9289785 10846835008869

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other 8.5F SHEATH WITH CURVE VIZ SMC| PENTARAY NAV ECO 7FR, D, 2-6-2| SMARTABLATE GEN. KIT (JAPAN)| THMCL SMTCH SF BID, TC, D-D| UNK BRAND CABLE