BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 17437694 · Received August 1, 2023

    Report

    Report Number
    2029046-2023-01654
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    May 5, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE: (B)(6). THE ¿SUSPECTED MEDICAL DEVICE¿ REPORTED IN SECTION D OF THIS REPORT IS NOT MARKETED IN USA OR APPROVED BY THE FDA. HOWEVER, IT IS BEING REPORTED AS BIOSENSE WEBSTER CONSIDERS THIS AS A SIMILAR DEVICE TO THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER APPROVED UNDER P030031/S053. THE INVESTIGATION WAS COMPLETED ON 03-JUL-2023. A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE TIP WAS OBSERVED SEMI-DEFLECTED; HOWEVER, THE PISTON POSITION WAS NOT OBSERVED. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED BASED ON THE PICTURE RECEIVED. THE PRODUCT ANALYSIS WAS PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. THE SMART TOUCH UNIDIRECTIONAL DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION AND DEFLECTION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THE DOME WAS FOUND BENT AND A HOLE IN THE PEBAX. A DEFLECTION TEST WAS PERFORMED, AND THE CURVE WAS DEFLECTING WITHIN SPECIFICATIONS. NO DEFLECTION ISSUES WERE OBSERVED. THE ROOT CAUSE OF THE DOME BENT AND THE HOLE IN THE PEBAX CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATIONS AND PROCEDURES, IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: APPROPRIATE TERM/CODE NOT AVAILABLE (C22) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE PHOTO PROVIDED. -INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19)/ INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED ¿DEFLECTION ISSUE¿. -INVESTIGATION FINDINGS: MATERIAL AND/OR CHEMICAL PROBLEM IDENTIFIED (C06) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: SLEEVE (G04115) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿HOLE IN THE PEBAX¿. -INVESTIGATION FINDINGS: STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: DOME (G04046) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE ¿DOME WAS FOUND BENT¿. MANUFACTURER'S REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A HOLE ON THE PEBAX. INITIALLY A DEFLECTION ISSUE WAS REPORTED. DURING THE PROCEDURE, THE CATHETER WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE DEFLECTION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 03-JUL-2023, THE DOME WAS FOUND BENT AND A HOLE IN THE PEBAX WAS OBSERVED. THE HOLE ON THE PEBAX WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 03-JUL-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697101 THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30785309M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND CATHETER