BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY STEERABLE DIAGNOSTIC CATHETER

    MDR report key: 10455564 · Received August 26, 2020

    Report

    Report Number
    2030404-2020-00063
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 15, 2020
    Report Date
    October 21, 2020
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    UDI-DI
    05414734302975
    PMA / PMN Number
    K961924
    Removal / Correction Number
    FA-Q320-EP-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 14-POLE, INQUIRY STEERABLE DIAGNOSTIC CATHETER WAS RECEIVED FOR EVALUATION. THE RETURNED CATHETER WAS A 14-POLE, INQUIRY STEERABLE DIAGNOSTIC CATHETER, HOWEVER, BATCH NUMBER 7397352 IS FOR A DECAPOLAR, INQUIRY STEERABLE DIAGNOSTIC CATHETER. NO OTHER VISUAL ANOMALIES WERE NOTED. A 14-POLE CATHETER WAS RECEIVED WITH A LABEL FOR A DECAPOLAR CATHETER, CONFIRMING THE INCORRECT CATHETER WAS PACKAGED IN THE BOX.

    Additional Manufacturer Narrative · 1

    THE RESULTS, METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00061, 2030404-2020-00062. DURING PREPARATION, IT WAS NOTED THAT THE INCORRECT CATHETER WAS IN THE PACKAGING ON THREE DIFFERENT CATHETERS. A FOURTH CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918321 INQUIRY STEERABLE DIAGNOSTIC CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. IBI-81104 7397352 05414734302975

    Patients

    Seq Age Sex Outcome Treatment
    1 INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2| INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER X2