BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMART TOUCH BIDIRECTIONAL SF

    MDR report key: 21113472 · Received January 9, 2025

    Report

    Report Number
    2029046-2025-00087
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    October 17, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031/S078
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. NOTE: FIELD B4. CATALOG SHOULD BE UNK_SMART TOUCH BIDIRECTIONAL SF NOTE: FOR FIELD D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. NOTE: NO INITIAL REPORTER INFORMATION IS AVAILABLE. 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. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL SF AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGICAL INTERVENTION. A CARDIAC PERFORATION WAS DISCOVERED AT THE RIGHT VENTRICULAR (RV) APEX WHERE A J&J MEDTECH BIOSENSE WEBSTER PACING CATHETER HAD BEEN PLACED AND WAS VISUALIZED AT THE AREA OF INJURY. A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A BOSTON SCIENTIFIC BI-VENTRICULAR SYSTEM DUE TO NON-FUNCTION. THERE WERE THREE ACTIVE LEADS, AND FOUR ABANDONED LEADS (IMPLANTED AS FAR BACK AS 2002) PRESENT IN THE PATIENT. A "J&J MEDTECH BIOSENSE WEBSTER PACING CATHETER" WAS INSERTED TO TEMPORARILY PACE THE PATIENT. WITH USE OF SPECTRANETICS LEAD LOCKING DEVICES AND A SPECTRANETICS GLIDELIGHT LASER SHEATH, THE THREE ACTIVE LEADS WERE SUCCESSFULLY EXTRACTED, AND THEN THE ABANDONED RIGHT VENTRICULAR (RV) LEAD WAS REMOVED. IMMEDIATELY AFTER THE ABANDONED RV LEAD WAS TAKEN OUT, THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP AND AN EFFUSION WAS DETECTED. A STERNOTOMY FOLLOWED. AN RV APEX MICRO-PERFORATION WAS DISCOVERED, AND THE BIOSENSE WEBSTER PACING CATHETER WAS VISUALIZED IN THE AREA OF THE PERFORATION. NO OTHER AREA OF INJURY WAS IDENTIFIED. THE PERFORATION WAS REPAIRED, THE PATIENT WAS PLACED ON BYPASS, AND THE REMAINING LEADS WERE MANUALLY REMOVED WHILE THE CHEST WAS OPEN. THE PATIENT SURVIVED THE PROCEDURE. IT WAS REPORTED THAT ALTHOUGH SPECTRANETICS DEVICES WERE USED DURING THE LEAD EXTRACTION, THE GLIDELIGHT DID NOT LASE AT THE RV LEAD TIP, NOR WAS THERE ANY OTHER EVIDENCE OF INJURY OTHER THAN WHERE THE BIOSENSE CATHETER WAS VISUALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379406 SMART TOUCH BIDIRECTIONAL SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| L BOSTON SCIENTIFIC BI-VENTRICULAR SYSTEM.| GLIDELIGHT LASER SHEATH.