BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMARTTOUCH SF

    MDR report key: 20253196 · Received September 18, 2024

    Report

    Report Number
    2029046-2024-03152
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 26, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND WATER FLOW FROM THE HOLE WAS WEAK. 70 MINUTES AFTER INSERTION OF THE CATHETER INTO THE PATIENT'S BODY, AT THE TIME OF TRANSITION FROM LEFT PULMONARY VEIN (LPV) ABLATION TO RIGHT PULMONARY VEIN (RPV) ABLATION, THE AMOUNT OF REMAINING SALINE SOLUTION IN THE IRRIGATION BAG WAS LOW SO THE BAG WAS REPLACED. HOWEVER, DESPITE FLUSHING, WATER FLOW FROM THE HOLE WAS WEAK. THERE WERE NO ERRORS IN THE IRRIGATION PUMP. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A BENT MARK IN THE SHAFT CLOSE TO THE HANDLE AREA. AN IRRIGATION TEST WAS PERFORMED, AND THE DEVICE WAS IRRIGATING CORRECTLY, NO OBSTRUCTED HOLES WERE OBSERVED. NO IRRIGATION ISSUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTION WERE IDENTIFIED. THE BENT CONDITION OBSERVED CLOSE TO THE HANDLE COULD BE RELATED TO THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER SINCE THE MARK COULD CAUSE AN OCCLUSION; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE BENT MARK COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: BEFORE USE, VERIFY THAT THE IRRIGATION PORTS ARE PATENT BY INFUSING HEPARINIZED NORMAL SALINE THROUGH THE CATHETER AND THE IRRIGATION TUBING. FLUSH THE CATHETER AND TUBING PER STANDARD TECHNIQUE TO ENSURE PURGING OF TRAPPED AIR BUBBLES AND TO VERIFY THAT THE IRRIGATION HOLES ARE PATENT. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND WATER FLOW FROM THE HOLE WAS WEAK. 70 MINUTES AFTER INSERTION OF THE CATHETER INTO THE PATIENT'S BODY, AT THE TIME OF TRANSITION FROM LEFT PULMONARY VEIN (LPV) ABLATION TO RIGHT PULMONARY VEIN (RPV) ABLATION, THE AMOUNT OF REMAINING SALINE SOLUTION IN THE IRRIGATION BAG WAS LOW SO THE BAG WAS REPLACED. HOWEVER, DESPITE FLUSHING, WATER FLOW FROM THE HOLE WAS WEAK. THERE WERE NO ERRORS IN THE IRRIGATION PUMP. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527264 THERMOCOOL SMARTTOUCH SF CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31314376L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SMARTABLATE PUMP KIT-WW.| UNKNOWN GENERATOR.