BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL

    MDR report key: 6321296 · Received February 10, 2017

    Report

    Report Number
    3002808486-2017-00382
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    December 3, 2013
    Report Date
    December 4, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    KRD
    UDI-DI
    00827002202337
    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: THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND NO IMAGES WERE PROVIDED. THE EVALUATION IS BASED ON THE EVENT DESCRIPTION ONLY. THE EVENT DESCRIPTION STATES THE USE OF A JR3 CATHETER WHICH DIAMETER SIZE IS 4FR. IFU STATES UNDER PRECAUTIONS: "IN ORDER TO OBTAIN STABILITY DURING COIL INTRODUCTION A 5.0 FRENCH, NON-TAPERED (NT) END HOLE, ONLY MULTIPURPOSE HEART CATHETER IS RECOMMENDED. MINIMUM LUMEN .041 INCHES." A 4FR CATHETER LACKS THE STABILITY NEEDED FOR THE PROCEDURE, AND IT IS UNKNOWN IF THE USED 4FR. CATHETER HAVE THE CORRECT MINIMUM LUMEN OF .041 INCHES. ADDITIONALLY, IT IS STATED IN THE DESCRIPTION OF EVENT, THAT THE TIP OF THE CATHETER WAS PLACED AT THE PATENT DUCTUS; HOWEVER IT IS UNKNOWN WHY THE COIL PROTRUDED INTO THE PULMONARY ARTERY IF THE TIP OF THE CATHETER WAS AT THE PATENT DUCTUS. FURTHERMORE IT IS STATED THAT "THE PHYSICIAN WITHDRAW THE DELIVERY WIRE, THE COIL WAS ALSO PULLED BACK TOWARDS THE AORTA AND BECAME STUCK." IFU STATES UNDER PRECAUTIONS THAT¿ IF DIFFICULTIES OCCUR THEN DETACHING THE EMBOLIZATION COIL, OF IF RESISTANCE IS WHEN WITHDRAWING THE DELIVERY WIRE, DO NOT ATTEMPT TO WITHDRAW THE DELIVERY WIRE. REMOVE THE GUIDING CATHETER AND THE DELIVERY WIRE WITH THE COIL SIMULTANEOUSLY AND REPLACE THE WHOLE SYSTEM. BASED ON THE DESCRIPTION OF EVENT IT IS LIKELY THAT THE COIL UNRAVELED SINCE THE PHYSICIAN TRIED TO WITHDRAW THE COIL BY ONLY PULLING THE DELIVERY WIRE. IT IS PLAUSIBLE THAT RESISTANCE WAS FELT DUE TO THE CATHETER USED. 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: A (B)(6) FEMALE PATIENT UNDERWENT COIL EMBOLIZATION OF PDA ON (B)(6) 2013. THE SMALLEST DIAMETER OF THE DUCTUS ARTERIOSUS WAS APPROX 0.6MM. A 5FR AND 4 FR MULTIPURPOSE CATHETERS AS WELL AS A JR3 CATHETER WOULD NOT BE ADVANCED TO THE PULMONARY ARTERY. THEREFORE A 0.035" WIRE GUIDE WAS ADVANCED TO THE PULMONARY ARTERY AND THE TIP OF THE JR3 CATHETER WAS PLACED AT THE PATENT DUCTUS. THEN THE PDA COIL WAS ADVANCED AND ABOUT ONE LOOP OF THE COIL WAS PROTRUDED INTO THE PULMONARY ARTERY. WHEN THE PHYSICIAN WITHDRAW THE DELIVERY WIRE, THE COIL WAS ALSO PULLED BACK TOWARDS THE AORTA AND BECAME STUCK. HE ATTEMPTED TO PULL THE COIL BACK INTO THE CATHETER BUT RESISTANCE WAS FELT AND THE COIL UNRAVELED. A 4MM SNARE CATHETER (GOOSENECK) WAS INSERTED FROM THE AORTA BUT THE COIL WOULD NOT BE RETRIEVED. THEN IT WAS INSERTED FROM THE PULMONARY ARTERY AND COIL WAS SUCCESSFULLY RETRIEVED. PATIENT OUTCOME: NO CHANGES IN THE CONDITIONS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105490 MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL KRD DEVICE, EMBOLIZATION, VASCULAR KRD WILLIAM COOK EUROPE 00827002202337

    Patients

    Seq Age Sex Outcome Treatment
    1 9 Required Intervention