BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 17279995 · Received July 7, 2023

    Report

    Report Number
    2029046-2023-01460
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 7, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER RECORD EVALUATION CANNOT BE CONDUCTED BECAUSE THE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. 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 PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN UNKNOWN SMART TOUCH BIDIRECTIONAL SF. THE PATIENT SUFFERED A PHRENIC NERVE DAMAGE. IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION PROCEDURE, THEY WERE USING THE CARDIOFOCUS LASER BALLOON CATHETER AND THEY HIT THE PHRENIC NERVE. THE MEDICAL TEAM REPORTED THAT THEY DISCOVERED THE ISSUE BECAUSE WHEN THEY USUALLY PACE IN AN AREA THAT THEY ARE ABLE TO ACTIVATE THE PHRENIC NERVES AND THE NERVES NORMALLY PULSATE, BUT THEY STOPPED PULSATING. THE REPORTED NO FURTHER PATIENT SYMPTOMS AND NO MEDICAL INTERVENTION WAS PROVIDED AT THE TIME. THE PATIENT IS NOW STABLE. THE CALLER DID REPORT THAT THEY WILL BE PERFORMING A FOLLOW-UP INTERVENTION BY COMPLETING TESTS IN A COUPLE OF WEEKS TO SEE IT THE NERVES HAVE RECOVERED. THE CARDIOFOCUS LASER BALLOON CATHETER WAS BEING USED WHEN THE EVENT OCCURRED. THE SOUNDSTAR CATHETER, THE PENTARAY CATHETER, AND THE SMARTTOUCH SF CATHETER WERE ALL USED DURING THE PROCEDURE. THE CALLER COULD ONLY PROVIDE CATHETER INFORMATION FOR THE PENTARAY CATHETER. PENTARAY CATHETER: REFERENCE: D128208 LOT# 31048751L THE ADVERSE EVENT OCCURRED ON (B)(6) 2023. IT WAS DISCOVERED IN BETWEEN, THEY HAD DONE RF ABLATION ON THE RIGHT SIDE OF THE HEART PREVIOUSLY BUT AT THE TIME OF THE EVENT THE ONLY BWI CATHETER IN THE BODY WAS THE SOUNDSTAR CATHETER. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THE PROCEDURE-FROM THE CARDIOFOCUS LASER BALLOON. NO FURTHER ABLATION DONE IN THAT AREA. NO OTHER INTERVENTION AT THAT TIME. OUTCOME OF THE ADVERSE EVENT WAS UNKNOWN-PATIENT STABLE. RELEVANT TESTS/LABORATORY DATA - NONE. OTHER RELEVANT HISTORY- NONE. SMARTABLATE G4C-4276-A WAS THE GENERATOR USED. THE LOT NUMBER OF DEVICE INVOLVED SMART TOUCH BIDIRECTIONAL SF WAS UNKNOWN, PRODUCT PACKAGING ALREADY DISPOSED OF. PRODUCT NOT AVAILABLE FOR RETURN. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613456 UNK_SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R CARDIOFOCUS LASER BALLOON CATHETER| PENTARAY NAV CATHETER| SMARTABLATE GENERATOR| SOUNDSTAR CATHETER