BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONANCE STENT SET

    MDR report key: 8022863 · Received October 31, 2018

    Report

    Report Number
    3001845648-2018-00508
    Event Type
    Injury
    Date Received
    October 31, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 4, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FAD
    UDI-DI
    10827002341095
    PMA / PMN Number
    K063742
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER: K063742. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. CANCELLATION REPORT IS BEING SUBMITTED. COMPLAINT (B)(4) WAS RAISED FOLLOWING RECEIPT OF AN FDA VOLUNTARY EVENT REPORT ON 02 OCT 2018. FOLLOWING INVESTIGATION IT WAS FOUND THAT COMPLAINT REF # (B)(4) (MDR REPORT REF 3001845648-2018-00479) WAS RAISED FOR THE SAME EVENT.

    Description of Event or Problem · 0

    PER THE SUS REPORT, "WHILE ATTEMPTING TO PLACE A URETERAL STENT A PIECE OF THE PUSH SHEATHING BROKE OFF FOR UNKNOWN REASONS. THE BROKEN PIECE WAS CLEARLY VISIBLE UNDER FLUOROSCOPY. A URETEROSCOPY WAS PERFORMED AND THE FOREIGN BODY WAS REMOVED IN ITS ENTIRETY. FLUOROSCOPY AND DIRECT VISION WERE AGAIN UTILIZED TO VERIFY NO REMAINING PIECES WERE LEFT. THE STENT WAS PLACED AND THE CASE FINISHED WITHOUT FURTHER INCIDENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864921 RESONANCE STENT SET FAD STENT, URETERAL FAD COOK IRELAND LTD G34109 C1435503 10827002341095

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention