BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 19423173 · Received May 30, 2024

    Report

    Report Number
    2029046-2024-01752
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    May 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835009781
    PMA / PMN Number
    P030031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER TIP WAS DAMAGED. IT WAS ALSO REPORTED THAT THE OUTER TABS WERE NOT ATTACHED INSIDE THE CATHETER PACKAGING SO THE CATHETER IS NOT HELD IN PLACE PROPERLY. CALLER STATED THE CATHETER WAS SMASHED INTO THE BOTTOM OF THE PACKAGING, WHICH GAVE THE CATHETER A BENT AND THE TIP WAS ALSO "SMASHED" INTO THE CATHETER. IT WAS UNKNOWN IF THE TIP WAS DAMAGED DUE TO IT FALLING OUT OF ITS PACKAGING. THERE WERE NO WIRES EXPOSED OR SHARP/LIFTED RINGS. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE WAS PERFORMED AND NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE DEVICE. THE PACKAGE OF THE DEVICE WAS NOT RETURNED BY THE CUSTOMER, HOWEVER, PHOTOS WERE RECEIVED WHICH SHOWED EVIDENCE OF THE PACKAGE ISSUE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE PACKAGING AND BENT SHAFT ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED BY THE PHOTOS RECEIVED. THE BROKEN TIP ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: THE STERILE PACKAGING AND CATHETER SHOULD BE INSPECTED PRIOR TO USE. DO NOT USE THE CATHETER IF THE PACKAGING OR CATHETER APPEARS DAMAGED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. EXPLANATION OF CODES: INVESTIGATION FINDINGS: PACKAGING PROBLEM IDENTIFIED (C1605) AND MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: PACKAGING (G04094) AND ROD/SHAFT (G04112) WERE SELECTED AS RELATED TO THE PACKAGING AND BENT ISSUES REPORTED BY THE CUSTOMER. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19) / INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER'S REPORTED BROKEN (SMASHED) TIP ISSUE REPORTED BY THE CUSTOMER. 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

    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

    ON 10-JUN-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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND THE CATHETER TIP WAS DAMAGED. IT WAS ALSO REPORTED THAT THE OUTER TABS WERE NOT ATTACHED INSIDE THE CATHETER PACKAGING SO THE CATHETER IS NOT HELD IN PLACE PROPERLY. CALLER STATED THE CATHETER WAS SMASHED INTO THE BOTTOM OF THE PACKAGING, WHICH GAVE THE CATHETER A BENT AND THE TIP WAS ALSO "SMASHED" INTO THE CATHETER. IT WAS UNKNOWN IF THE TIP WAS DAMAGED DUE TO IT FALLING OUT OF ITS PACKAGING. THERE WERE NO WIRES EXPOSED OR SHARP/LIFTED RINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580453 THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 31220642L 10846835009781

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown