BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 4F, 45 CM, MULTIPACK

    MDR report key: 21312444 · Received February 5, 2025

    Report

    Report Number
    3003637635-2025-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    November 25, 2024
    Report Date
    March 26, 2025
    Manufacturer
    CONTRACT MEDICAL INTERNATIONAL
    Product Code
    DYB
    UDI-DI
    04251244503604
    PMA / PMN Number
    K100799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT SUBMITTED ON 05 FEBRUARY 2025, PER MFR REPORT #: 3003637635-2025-00002. THE COMPLAINT DEVICES WAS NOT RETURNED. THEREFORE TESTING OF THE ACTUAL DEVICE IN THE REPORTED ADVERSE EVENT IS NOT POSSIBLE. THE DHR/BATCH RECORD REVIEW SHOWED THAT THERE IS NO PRODUCTION OR DESIGN ISSUE THAT CAN LEAD TO THE DEFECT WHICH CAUSED THE COMPLAINT CASE. ROOT CAUSE IS UNDERMINABLE.

    Additional Manufacturer Narrative · 0

    THE PROBLEM DESCRIPTION INDICATES THAT MULTIPLE DEVICES (2) WERE INVOLVED IN THE INCIDENT. IT SHOULD THEREFORE BE NOTED THAT THE MANUFACTURER HAS CONCLUDED THAT ONLY ONE OF THE TWO DEVICES MAY HAVE CONTRIBUTED TO THIS MDR REPORTABLE EVENT. THEREFORE, A SEPARATE REPORT RELATED TO THE OTHER DEVICE WILL NOT BE SUBMITTED. THE COMPLAINT DEVICE WILL NOT BE RETURNED FOR AN EVALUATION. IT WAS DISCARDED BY THE HEALTHCARE FACILITY. THE DHR REVIEW, WHICH EXAMINES THE DHR, NCRS, AND ECOS WILL BE DONE AS PART OF ROOT CAUSE INVESTIGATION. THE ROOT CAUSE OF THE INCIDENT IS UNKNOWN AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 0

    THE PROBLEM WAS DESCRIBED AS: "DURANT UNE INTERVENTION ENDOVASCULAIRE, NOUS AVONS UTILISÉ DEUX INTRODUCTEURS DE 4F LONGS FORTRESS (MÊME LOT: 800441), LE PREMIER ÉTAIT DÉFECTUEUX CAR LE MANDRIN DE RENTRAIT PAS AISÉMENT DANS L'INTRODUCTEUR ET LE DEUXIÈME S'EST COMPLÈTEMENT DÉTRUIT LORSQUE LA CHIRURGIENNE A TENTÉ DE LE RETIRER DE L'ARTÈRE ILIAQUE GAUCHE. IL NOUS SEMBLE QUE LE DISPOSITIF EST COMPLÈTEMENT RESSORTI, BIEN QUE EN PLUSIEURS MORCEAUX MAIS POSSIBILITÉ DE DÉBRIS RESTANTS DANS LA PATIENTE. DURING AN ENDOVASCULAR PROCEDURE, WE USED TWO FORTRESSES LONG 4F INTRODUCERS (SAME LOT: 800441), THE FIRST OF WHICH WAS DEFECTIVE BECAUSE THE DILATOR DID NOT FIT EASILY INTO THE INTRODUCER AND THE SECOND WAS COMPLETELY DESTROYED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE LEFT ILIAC ARTERY. IT SEEMS TO US THAT THE DEVICE CAME OUT COMPLETELY, ALBEIT IN SEVERAL PIECES, BUT THERE IS A POSSIBILITY OF DEBRIS REMAINING IN THE PATIENT." L'INCIDENT A-T-IL EFFECTIVEMENT EU DES CONSÉQUENCES GRAVES POUR LE PATIENT, L'UTILISATEUR OU UN TIERS? NON. DID THE INCIDENT HAVE SERIOUS CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY? NO. VEUILLEZ DÉCRIRE LES CONSEQUENCES GRAVES POSSIBLES ET INDIQUER LA RAISON POUR LAQUELLE L'INCIDENT EST CONSIDÉRÉ COME GRAVE: RISQUE DE CORPS ÉTRANGER. RISQUE DE CONVERSION EN CHIRURGIE OUVERTE. RISQUE D'EMBOLIE. PLEASE DESCRIBE THE POSSIBLE SERIOUS CONSEQUENCES AND INDICATE THE WHY THE INCIDENT IS CONSIDERED SERIOUS: RISK OF FOREIGN BODY. RISK OF CONVERSION TO OPEN SURGERY. RISK OF EMBOLISM. ON 22.01.2025, CUSTOMER PROVIDED ADDITIONAL INFORMATION AS BELOW: "UNFORTUNATELY, THEY (HOSPITAL) HAVEN'T KEPT THE DEVICES. I DON'T HAVE MORE INFORMATION THAN THE INTRODUCERS BROKE, BUT NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT."

    Description of Event or Problem · 0

    THE PROBLEM WAS DESCRIBED AS: "DURANT UNE INTERVENTION ENDOVASCULAIRE, NOUS AVONS UTILISÉ DEUX INTRODUCTEURS DE 4F LONGS FORTRESS (MÊME LOT: 800441), LE PREMIER ÉTAIT DÉFECTUEUX CAR LE MANDRIN DE RENTRAIT PAS AISÉMENT DANS L'INTRODUCTEUR ET LE DEUXIÈME S'EST COMPLÈTEMENT DÉTRUIT LORSQUE LA CHIRURGIENNE A TENTÉ DE LE RETIRER DE L'ARTÈRE ILIAQUE GAUCHE. IL NOUS SEMBLE QUE LE DISPOSITIF EST COMPLÈTEMENT RESSORTI, BIEN QUE EN PLUSIEURS MORCEAUX MAIS POSSIBILITÉ DE DÉBRIS RESTANTS DANS LA PATIENTE. DURING AN ENDOVASCULAR PROCEDURE, WE USED TWO FORTRESS LONG 4F INTRODUCERS (SAME LOT: 800441), THE FIRST OF WHICH WAS DEFECTIVE BECAUSE THE DILATOR DID NOT FIT EASILY INTO THE INTRODUCER AND THE SECOND WAS COMPLETELY DESTROYED WHEN THE SURGEON TRIED TO REMOVE IT FROM THE LEFT ILIAC ARTERY. IT SEEMS TO US THAT THE DEVICE CAME OUT COMPLETELY, ALBEIT IN SEVERAL PIECES, BUT THERE IS A POSSIBILITY OF DEBRIS REMAINING IN THE PATIENT. "L'INCIDENT A-T-IL EFFECTIVEMENT EU DES CONSÉQUENCES GRAVES POUR LE PATIENT, L'UTILISATEUR OU UN TIERS ?: NON . DID THE INCIDENT HAVE SERIOUS CONSEQUENCES FOR THE PATIENT, USER OR THIRD PARTY?: NO . VEUILLEZ DÉCRIRE LES CONSEQUENCES GRAVES POSSIBLES ET INDIQUER LA RAISON POUR LAQUELLE L'INCIDENT EST CONSIDÉRÉ COME GRAVE: RISQUE DE CORPS ÉTRANGER. RISQUE DE CONVERSION EN CHIRURGIE OUVERTE. RISQUE D'EMBOLIE. PLEASE DESCRIBE THE POSSIBLE SERIOUS CONSEQUENCES AND INDICATE THE WHY THE INCIDENT IS CONSIDERED SERIOUS: RISK OF FOREIGN BODY. RISK OF CONVERSION TO OPEN SURGERY. RISK OF EMBOLISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135058 BIOTRONIK FORTRESS INTRODUCER SHEATH SYSTEM, 4F, 45 CM, MULTIPACK INTRODUCER SHEATH DYB CONTRACT MEDICAL INTERNATIONAL FG-04551-101 800441 04251244503604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention