BEUDAMED
    FDA Adverse Event Summary report: N

    THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 6211098 · Received December 28, 2016

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    Report

    Report Number
    9673241-2016-00912
    Date Received
    December 28, 2016
    Date of Event
    September 7, 2016
    Report Date
    September 7, 2016
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    UDI-DI
    10846835009200
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER. AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, BLOOD WAS NOTICED INSIDE THE COILS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE RETURNED DEVICE WAS VISUALLY INSPECTED UPON RECEIPT AND REDDISH MATERIAL WAS FOUND INSIDE THE PEBAX AND A SCRATCH WAS IDENTIFIED IN THIS AREA. PER THIS CONDITION A SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED OVER THE PEBAX AREA OF CATHETER AND IT WAS FOUND THAT THE EXTERNAL SURFACE EXHIBITED EVIDENCE OF SCRATCHES AND RUPTURE. IT IS POSSIBLE THAT AN UNKNOWN OBJECT HIT AND RUPTURED THE PEBAX. DURING MANUFACTURING ALL THE CATHETERS ARE INSPECTED FOR VISUAL DAMAGES BEFORE PACKAGING. ON LINE INSPECTIONS ARE IN PLACE TO PREVENT THIS TYPE OF DAMAGE/DEFECT FROM LEAVING THE FACILITY. PER THE EVENT REPORTED, THE CATHETER WAS TESTED FOR ELECTRICAL PERFORMANCE, TEMPERATURE RESPONSE AND GENERATOR COMPATIBILITY AND IT WAS FOUND WITHIN SPECIFICATIONS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE CUSTOMER COMPLAINT REGARDING BLOOD INSIDE THE COILS HAS BEEN CONFIRMED. BASED ON AVAILABLE ANALYSIS FINDING A RESULT, THE FAILURE MODE DOES NOT APPEAR TO BE CAUSED BY ANY INTERNAL BIOSENSE WEBSTER, INC. PROCESSES; SINCE SEVERAL INSPECTIONS ARE IN PLACE TO PREVENT THIS DEVICE CONDITION.

    Additional Manufacturer Narrative · 1

    THE BWI FAILURE ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) PROCEDURE WITH A SMART TOUCH BIDIRECTIONAL CATHETER. INITIALLY IT WAS REPORTED THAT WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, BLOOD WAS NOTICED INSIDE THE COILS. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE ISSUE WITH BLOOD INSIDE THE CATHETER TIP WAS ASSESSED AS NOT REPORTABLE AS IT IS AN EXPECTED FINDING DURING THESE PROCEDURES AND THERE WAS NO DAMAGE REPORTED TO THE PEBAX INTEGRITY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT WAS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR ANALYSIS. DURING THE ANALYSIS ON (B)(6) 2016, IT WAS FOUND THAT THERE WAS REDDISH BROWN MATERIAL OBSERVED INSIDE OF THE PEBAX. DURING THE INSPECTION, A PINHOLE WAS LOCATED AND CONFIRMED THROUGH SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS. THE PRESENCE OF REDDISH BROWN MATERIAL IS NOT REPORTABLE, AS IT IS AN EXPECTED FINDING AFTER THESE PROCEDURES. THE ISSUE WITH THE PINHOLE IS A REPORTABLE MALFUNCTION SINCE THE PATIENT CAN BE EXPOSED TO INTERNAL PARTS OF THE CATHETER. THIS CAN LEAD TO ISSUES SUCH AS THROMBUS. THE AWARENESS DATE WAS RESET TO (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860669 THERMOCOOL® SMARTTOUCH® BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1327-05-S 17519512M 10846835009200

    Patients

    Seq Age Sex Outcome Treatment
    1