BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 4963212 · Received August 4, 2015

    Report

    Report Number
    9673241-2015-00501
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING A PROCEDURE, THE CUSTOMER EXPERIENCED FORCE ISSUE WITH A SMART TOUCH BIDIRECTIONAL SF CATHETER. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. THIS ISSUE IS NOT REPORTABLE. IN ADDITION, WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE CUSTOMER NOTICED BLOOD INSIDE THE TIP OF CATHETER. THIS ISSUE WAS NOT REPORTABLE SINCE THERE WAS NO EXPOSURE OF INTERNAL COMPONENTS OR ANY EVIDENCE THAT THE INTEGRITY OF THE CATHETER HAS BEEN COMPROMISED WAS REPORTED. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB ON JULY 17TH 2015, IT WAS NOTICED THAT CLEAR SENSOR SLEEVE HAS DAMAGE PU MARGIN ON PROXIMAL SIDE OF RING #1 ALLOWING REDDISH BROWN MATERIAL TO ENTER INSIDE THE SLEEVE. PU IS PEELING ON THE PROXIMAL SIDE OF RING #1, MAKING THIS EVENT REPORTABLE. UPON RECEIVED THE CATHETER WAS VISUALLY INSPECTED AND IT WAS FOUND THAT CLEAR SENSOR SLEEVE HAS DAMAGE PU MARGIN ON PROXIMAL SIDE OF RING #1 ALLOWING REDDISH BROWN MATERIAL TO ENTER INSIDE THE SLEEVE. PU IS PEELING ON THE PROXIMAL SIDE OF RING #1 SCANNING ELECTRON MICROSCOPE (SEM) RESULTS SHOWED THAT THE DAMAGE OBSERVED ON PU PRESENTED EVIDENCE OF DAMAGES BY A SHARP POINT OBJECT, IT COULD BE OBSERVED THAT THERE IS A KIND OF FISSURE, THE DAMAGE OBSERVED COULD PROBABLY CAUSE THE BLOOD FILTRATION INSIDE OF PEBAX THEN THE CATHETER WAS TESTED PER THE REPORTED EVENT ON EEPROM AND CALIBRATION TEST AND THE CATHETER PASSED EEPROM TEST BUT FAILED CARTO TEST. ERROR 106 APPEARS. THE CATHETER WAS THEN DISSECTED AND IT WAS DETERMINED THAT THE ROOT CAUSE WAS AN INTERNAL FAILURE OF THE SENSOR. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. IN ADDITION, THE DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. CUSTOMER COMPLAINT HAS BEEN CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE CUSTOMER EXPERIENCED FORCE ISSUE WITH A SMART TOUCH BIDIRECTIONAL SF CATHETER. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER WITHOUT ANY PATIENT CONSEQUENCE. THIS ISSUE IS NOT REPORTABLE. IN ADDITION, WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE CUSTOMER NOTICED BLOOD INSIDE THE TIP OF CATHETER. THIS ISSUE WAS NOT REPORTABLE SINCE THERE WAS NO EXPOSURE OF INTERNAL COMPONENTS OR ANY EVIDENCE THAT THE INTEGRITY OF THE CATHETER HAS BEEN COMPROMISED WAS REPORTED. UPON RECEIVING THE PRODUCT IN BIOSENSE WEBSTER LAB ON JULY 17TH 2015, IT WAS NOTICED THAT CLEAR SENSOR SLEEVE HAS DAMAGE PU MARGIN ON PROXIMAL SIDE OF RING #1 ALLOWING REDDISH BROWN MATERIAL TO ENTER INSIDE THE SLEEVE. PU IS PEELING ON THE PROXIMAL SIDE OF RING #1, MAKING THIS EVENT REPORTABLE. INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510299 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER SIMILAR DEVICE D132701, PMA # P030031/S053 LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S 17107295L

    Patients

    Seq Age Sex Outcome Treatment
    1