BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3010635 · Received March 19, 2013

    Report

    Report Number
    9673241-2013-00078
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) IT WAS REPORTED THAT DURING ABLATION OF A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (WPW-A TYPE) PROCEDURE, UPON CONNECTING THE CATHETER, THERE WAS SIGNAL NOISE AT THE ELECTRICAL POTENTIALS. ABLATION WAS ATTEMPTED ALTHOUGH THE ISSUE WAS LEFT, BUT THE WAVEFORMS OF THE ELECTRICAL POTENTIALS DID NOT SHOW VARIATION AT ALL. UPON FURTHER FOLLOW-UP IT WAS UNKNOWN IF THE SIGNALS NOISE WAS CONFIRMED TO ON ALL CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE ECG¿S AND ALL INTRACARDIAL (IC) RECORDINGS ON BOTH CARTO 3 AND EP RECORDING SYSTEMS SIMULTANEOUSLY. THE PHYSICIAN WAS UNABLE TO INTERPRET THE SIGNALS. THE USER PROCEEDED BY CHANGING TO A NEW CATHETER. NO PATIENT CONSEQUENCE WAS REPORTED. UPON RECEIPT, THE DEVICE WAS VISUALLY INSPECTED AND IT WAS FOUND IN NORMAL CONDITIONS. THE CATHETER WAS ELECTRICALLY TESTED AND IT PASSED SPECIFICATIONS. THE DEVICE HISTORY RECORD 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 CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ABLATION OF A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (WPW-A TYPE) PROCEDURE, UPON CONNECTING THE CATHETER, THERE WAS SIGNAL NOISE AT THE ELECTRICAL POTENTIALS. ABLATION WAS ATTEMPTED ALTHOUGH THE ISSUE WAS LEFT, BUT THE WAVEFORMS OF THE ELECTRICAL POTENTIALS DID NOT SHOW VARIATION AT ALL. UPON FURTHER FOLLOW-UP IT WAS UNKNOWN IF THE SIGNALS NOISE WAS CONFIRMED TO ON ALL CHANNELS, INCLUDING THE 12 LEADS OF BODY SURFACE ECG'S AND ALL INTRACARDIAL (IC) RECORDINGS ON BOTH CARTO 3 AND EP RECORDING SYSTEMS SIMULTANEOUSLY. THE PHYSICIAN WAS UNABLE TO INTERPRET THE SIGNALS. THE USER PROCEEDED BY CHANGING TO A NEW CATHETER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113467 NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1197-15-S 15671067M

    Patients

    Seq Age Sex Outcome Treatment
    1