BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 STEERABLE GUIDING CATHETER

    MDR report key: 15611260 · Received October 14, 2022

    Report

    Report Number
    2135147-2022-01633
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    September 21, 2022
    Report Date
    December 10, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRA
    UDI-DI
    08717648231025
    PMA / PMN Number
    K190167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    SUBSEQUENT TO THE INITIAL REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED THAT THIS WAS A DUPLICATE OF A PREVIOUSLY REPORTED EVENT, (B)(4). THE EVENT AND INVESTIGATION WILL BE CAPTURED IN (B)(4). (B)(4) INITIAL MEDWATCH REPORT NUMBER -- 2135147-2022-01624-00. (B)(4) SUPPLEMENTAL MEDWATCH REPORT NUMBER -- 2135147-2022-01624-01. (B)(4) FINAL REPORT NUMBER, CAPTURING THE EVENT, AND DEVICE RETURN ANALYSIS -- 2135147-2022-01624-02. D9: DEVICE RETURN DATE ADDED. THE DEVICE RETURN ANALYSIS, AND INVESTIGATION WILL BE REPORTED IN A DUPLICATE CN, (B)(4). E: PRIMARY OPERATOR NAME UPDATED. H3: DEVICE RETURN UPDATED TO YES. THE DEVICE RETURN ANALYSIS AND INVESTIGATION WILL BE REPORTED IN A DUPLICATE CN, (B)(4). H6: HEALTH EFFECT ¿ IMPACT CODE 4641 REMOVED AND REPLACED WITH 2199 AS THIS CN WAS DISCOVERED A DUPLICATE AND (B)(4) WILL CAPTURE THE EVENT. MEDICAL DEVICE PROBLEM CODE 1354 REMOVED AND REPLACED WITH 3189 AS THIS CN WAS DISCOVERED A DUPLICATE AND (B)(4) WILL CAPTURE THE EVENT.

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT A LEAK REQUIRING INTERVENTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITAION (MR) WITH A GRADE OF 4. WHILE INTRODUCING THE CLIP DELIVERY SYSTEM (CDS) INTO THE STEERABLE GUIDE CATHETER (SGC) THERE WAS LOSS OF FLUID COLUMN. THERE WAS AIR IN THE DEVICE AND ASPIRATION WAS PERFORMED TO REMOVE THE AIR. THE PHYSICIAN TRIED SEVERAL TIMES BUT IT KEPT LOOSING FLUID. THE SGC WAS REPLACED WITH A NEW ONE AND THE PROCEDURE CONTINUED. ONE CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO A GRADE OF <1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL REPORT, THE ADDITIONAL INFORMATION WAS RECEIVED THAT THIS WAS A DUPLICATE OF A PREVIOUSLY REPORTED EVENT, (B)(4). THE EVENT AND INVESTIGATION WILL BE CAPTURED IN (B)(4). (B)(4) INITIAL MEDWATCH REPORT NUMBER -- 2135147-2022-01624-00. (B)(4) SUPPLEMENTAL MEDWATCH REPORT NUMBER -- 2135147-2022-01624-01. (B)(4) FINAL REPORT NUMBER, CAPTURING THE EVENT, AND DEVICE RETURN ANALYSIS -- 2135147-2022-01624-02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2876867 G4 STEERABLE GUIDING CATHETER CATHETER, STEERABLE DRA ABBOTT MEDICAL SGC0701 20329R325 08717648231025

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention CLIP DELIVERY SYSTEM.