BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVISTAR® THERMOCOOL®

    MDR report key: 3821854 · Received May 20, 2014

    Report

    Report Number
    2029046-2014-00145
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT DURING THIS PROCEDURE, THE NAVISTAR THERMOCOOL CATHETER COULD NOT APPERCEIVE MAGNETIC SIGNAL ON THE CARTO 3 SYSTEM. THE CATHETER WAS EXCHANGED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER, IT WAS NOTED THAT THE PEEK HOUSING WAS BENT AND CRACKED OPEN BETWEEN ELECTRODE RINGS #1 AND #2 LEAVING INTERNAL PARTS EXPOSED. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THE RETURNED CATHETER CONDITION WAS INDICATIVE OF A REPORTABLE EVENT. THE DEVICE WAS TESTED AND IT PASSED EEPROM DATA TEST, HOWEVER RE-CALIBRATION TEST COULD NOT BE PERFORMED DUE TO THE CATHETER TIP DAMAGED CONDITION. ALSO, AN ELECTRICAL TEST WAS PERFORMED AND THE CATHETER FAILED, NO READINGS WERE OBSERVED ON ELECTRODE #1 DUE TO A CRACKED CONDITION PRESENTED ON THE PEEK HOUSING. BASED ON THE CONTINUITY TEST, NO DAMAGE OR DEFECT WAS FOUND WITH THE WIRING, SENSOR COILS, SOLDERING, OR SHORTS. THIS CONCLUDES THAT THE FAILURE IS RELATED TO THE PCB BOARD MALFUNCTION. THE CATHETER WAS SENT TO SEM (SCANNING ELECTRON MICROSCOPE) ANALYSIS TO DETERMINE THE CAUSE OF THE FRACTURE ON THE PEEK HOUSING AND RESULTS SHOWED THAT THE SAMPLE RECEIVED PRESENTED EVIDENCE ELONGATIONS AND STRESS MARKS WERE ALSO OBSERVED. THE REST OF THE PEEK HOUSING PRESENTED EVIDENCE OF FATIGUE. THE ELONGATIONS FOUND SUGGESTED THAT THE SAMPLE WAS PULLED OFF UNTIL RUPTURE. NO OTHER ANOMALIES WERE OBSERVED DURING ANALYSIS. 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 HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION STILL IN PROGRESS. A SUPPLEMENTAL REPORT OR DEVICE EVALUATION WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THIS PROCEDURE, THE NAVISTAR THERMOCOOL CATHETER COULD NOT APPERCEIVE MAGNETIC SIGNAL ON THE CARTO 3 SYSTEM. THE CATHETER WAS EXCHANGED. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT INJURY REPORTED. THE INITIAL REPORTED COMPLAINT ITSELF WAS NOT INDICATIVE OF A REPORTABLE EVENT. UPON VISUAL INSPECTION OF THE RETURNED COMPLAINT CATHETER ON APRIL 30, 2014, THE BWI FAILURE ANALYSIS LAB NOTED THAT THE PEEK HOUSING WAS BENT AND CRACKED OPEN BETWEEN ELECTRODE RINGS #1 AND #2 LEAVING INTERNAL PARTS EXPOSED. THIS CONDITION WAS NOT REPORTED BY THE CUSTOMER. THE RETURNED CATHETER CONDITION IS INDICATIVE OF A REPORTABLE EVENT, THUS MARKING APRIL 30, 2014 AS THE AWARENESS DATE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300323 NAVISTAR® THERMOCOOL® CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-16-S UNKNOWN_D-1197-16-S IRW

    Patients

    Seq Age Sex Outcome Treatment
    1