BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM

    MDR report key: 6344877 · Received February 21, 2017

    Report

    Report Number
    3002808486-2017-00545
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    November 26, 2012
    Report Date
    December 4, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002200265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) K063619. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: USED TDS RETURNED TO AID THE INVESTIGATION. VISUAL INSPECTION SHOWED NO PROBLEMS WITH THE TDS WIRE OR THREAD. NO PARTS OF THE COIL REMAINED AT THE TDS WIRE. A FUNCTIONAL TEST WAS PERFORMED BY CONNECTING A PDA COIL TO THE RETURNED DELIVERY WIRE AND NO ISSUES WAS FOUND WITH THIS PROCEDURE. SINCE NO PART OF THE COIL WAS LEFT ON THE WIRE IT IS PLAUSIBLE THAT THE PHYSICIAN DETACHED THE COIL INADVERTENTLY DUE TO COUNTERCLOCKWISE ROTATION OF THE WIRE DURING INSERTION. NO EVIDENCE TO SUGGEST DEVICE NOT MANUFACTURED TO CURRENT SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE WAS USED FOR PDA CLOSURE. THERE WAS NO PROBLEM IN VESSELS. THE COIL WAS ENTERED FROM PULMONARY ARTERY TO AORTA SIDE. WHEN THE PHYSICIAN WITHDREW A DELIVERY SYSTEM BEFORE DETACHING THE COIL, THE COIL WAS DETACHED. SINCE THE COIL WAS PLACED WITH NO PROBLEM THOUGH DETACHMENT OCCURRED UNEXPECTEDLY, THE PROCEDURE WAS COMPLETED. PATIENT OUTCOME: THERE HAS NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128504 FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002200265

    Patients

    Seq Age Sex Outcome Treatment
    1