BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER

    MDR report key: 12257624 · Received August 2, 2021

    Report

    Report Number
    2029046-2021-01229
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    July 7, 2021
    Report Date
    October 13, 2021
    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

    ON 13-AUG-2021, 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).

    Additional Manufacturer Narrative · 0

    ON 21-SEP-2021, BIOSENSE WEBSTER INC. (BWI) RECEIVED ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT. IT WAS CONFIRMED THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE WAS RESOLVED BY CHANGING TO ANOTHER CATHETER TO RESOLVE THE PROBLEM. THE DAMAGE DID NOT RESULT IN WIRES/INTERNAL COMPONENTS BEING EXPOSED OR LIFTED OR SHARP RINGS, HOWEVER, THERE WAS RESISTANCE DURING INSERTION OF THE CATHETER. THE CATHETER WAS NOT PRE-SHAPED AND THE SHEATH USED WAS AN ABBOTT L01 SHEATH. THE REPORTED ¿RESISTANCE WITH THE SHEATH¿ ISSUE IS NOT CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION SINCE INTERFERENCE OR FRICTION BETWEEN DEVICES IS A KNOWN OCCURRENCE. IF RESISTANCE IS ENCOUNTERED, THE SYSTEM MAY BE WITHDRAWN AS A UNIT. THIS IS A COMMON PRACTICE DURING PROCEDURES. SINCE THE VAST MAJORITY OF EP PROCEDURES UTILIZE MULTIPLE DEVICE EXCHANGES, AN INCREASED POTENTIAL FOR PATIENT INJURY IS REMOTE. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. ON 27-SEP-2021, THE DEVICE EVALUATION WAS COMPLETED. BWI CONDUCTED VISUAL INSPECTION, OUTER DIAMETER EVALUATION AND DEFLECTION TEST OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER. DEFLECTION TESTING WAS PERFORMED, IN ACCORDANCE WITH BWI PROCEDURES. THE DEFLECTION MECHANISM PASSED THE TEST; CURVE MET THE SPECIFICATION. OUTER DIAMETER OF POLYURETHANE MARGINS WAS MEASURED IN ACCORDANCE WITH BWI PROCEDURES. THE CATHETER WAS WORKING CORRECTLY, AND THE DEVICE WAS FOUND WITHIN SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [30538293M] NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. AS PART OF BWI¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. THE INSTRUCTION FOR USE CONTAINS THE FOLLOWING INFORMATION: IN ORDER TO PREVENT DAMAGE TO THE CATHETER TIP, USE THE INSERTION TUBE SUPPLIED WITH THE CATHETER TO ADVANCE OR RETRACT THE CATHETER THROUGH THE HEMOSTASIS VALVE OF THE SHEATH. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE WAS FOUND WITH THE DEFLECTION CURVE WITHIN SPECIFICATIONS. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. 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 · 1

    DEVICE INVESTIGATION DETAILS: THE CUSTOMER COMPLAINT WAS CONFIRMED FROM THE PHOTO ANALYSIS. HOWEVER, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SINCE NO DEVICE HAS BEEN RECEIVED, NO PRODUCT INVESTIGATION CAN BE PERFORMED. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT ANALYSIS WILL BE PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. 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 · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER WHEREIN THE CATHETER BECAME KNOTTED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE CATHETER WAS BENT AND A SECOND CATHETER WAS USED TO COMPLETED THE PROCEDURE. HOWEVER, THE CUSTOMER PROVIDED A PHOTO OF THE COMPLAINT CATHETER A REVIEW OF THE PHOTO SHOWS THE CATHETER IS KNOTTED. THIS EVENT HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155479 THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 LPB BIOSENSE WEBSTER INC 30538293M

    Patients

    Seq Age Sex Outcome Treatment
    1 ABBOTT L01 SHEATH.| THMCL SMARTTOUCH,TC,D,C3,OBL.| THMCL SMARTTOUCH,TC,D,C3,OBL