BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WOVEN DIAGNOSTIC ELECTRODE CATHETER

    MDR report key: 6371816 · Received March 2, 2017

    Report

    Report Number
    2134265-2017-01634
    Event Type
    Injury
    Date Received
    March 2, 2017
    Date of Event
    February 10, 2017
    Report Date
    February 10, 2017
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DRF
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UNDER 18 YEARS. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TACHYCARDIA OCCURRED. PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION WAS PERFORMED IN THE HIGH RIGHT ATRIUM (HRA) WITH THE 4F,110CM,JOS.4E,5MM,SLC WOVEN DIAGNOSTIC ELECTRODE CATHETER. PATIENT WAS DIAGNOSED WITH ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) BY EPS AND STARTED THE TREATMENT. TREATMENT WAS PERFORMED USING NON-BSC NON-IRRIGATION ABLATION CATHETER, BUT IT WAS UNABLE TO PERFORM THE TREATMENT SUCCESSFULLY. THEN, THE TREATMENT WAS PERFORMED AGAIN BY A NON-BSC IRRIGATION CATHETER, AND AFTER THE FIRST CURRENT DELIVERY WAS PERFORMED IT PROGRESSED TO A-V BLOCK. THE 4F,110CM,JOS.4E,5MM,SLC WOVEN DIAGNOSTIC ELECTRODE CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE TREATMENT WAS ENDED AND PATIENT WAS SENT FOR FOLLOW-UP OBSERVATION. PATIENT LEFT THE CATHETER LABORATORY WITH CURRENT 2:1 TRANSMISSION. NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154676 WOVEN DIAGNOSTIC ELECTRODE CATHETER CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BOSTON SCIENTIFIC - COSTA RICA (COYOL) H3014FMC007151

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention