BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLOCKING DETACHABLE COIL

    MDR report key: 4410363 · Received January 12, 2015

    Report

    Report Number
    2134265-2014-08380
    Event Type
    Injury
    Date Received
    January 12, 2015
    Report Date
    December 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KRD
    PMA / PMN Number
    K110295
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: GRONVALL, M. ET. AL. "PELVIC ARTERIAL EMBOLIZATION IN SEVERE OBSTETRIC HEMORRHAGE"; ACTA OBSTETRICIA ET GYNECOLOGICA SCANDINAVICA 93 (2014) 716¿719. IMPLANT DATE: BETWEEN (B)(6) 2001 AND (B)(6) 2011. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED; THEREFORE, DIRECT PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT FOLLOWING USE OF EMBOLIZATION AGENTS INGUINAL HEMATOMA, INGUINAL PAIN OCCURRED IN THREE WOMEN AND IATROGENIC RUPTURE OF ILIAC ARTERY OCCURRED IN ONE WOMAN. THE GOAL OF THE RETROSPECTIVE STUDY WAS A TO FIND OUT THE SUCCESS RATE OF PELVIC ARTERIAL EMBOLIZATION (PAE) IN CASES OF ACUTE POSTPARTUM HEMORRHAGE (PPH). DELIVERY WAS CLASSIFIED AS SECONDARY PPH. PPH WAS PRIMARILY MANAGED CONSERVATIVELY ACCORDING TO THE FACILITIES PRACTICE GUIDELINES. DEPENDING ON THE SITE OF BLEEDING, ALL NECESSARY SURGICAL PROCEDURES WERE PERFORMED TO STOP BLEEDING SUCH AS SUTURING OF THE TEARS, MANUAL EXTRACTION OF THE PLACENTA OR CURETTAGE, UTERINE COMPRESSIVE SUTURES, BILATERAL LIGATION OF UTERINE OR INTERNAL ILIAC ARTERIES, OR EMERGENCY PERIPARTUM HYSTERECTOMY. IF BLEEDING CONTINUED BUT THE WOMAN WAS HEMODYNAMICALLY STABLE, EMBOLIZATION WAS PERFORMED. THE PRIMARY EMBOLIZATION AGENT WAS GELATIN (NON-BSC). INTERLOCK COILS AND POLYVINYL ALCOHOL PARTICLE (NON BSC) AGENTS WERE ALSO USED IN COMBINATION WITH THE GELATIN IN FOUR WOMEN. THE RUPTURE OF ILIAC ARTERY OCCURRED DURING THE CATHETERIZATION PROCEDURE AND IMMEDIATE LAPAROTOMY WITH REPAIR WAS PERFORMED. IT WAS NOT SPECIFIED IN THE JOURNAL ARTICLE WHICH TYPE OF EMBOLIZATION AGENT WAS USED IN EACH OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25599 INTERLOCKING DETACHABLE COIL DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD BOSTON SCIENTIFIC - CORK UNK716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention