BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIT-OCCLUD PDA

    MDR report key: 6938883 · Received October 10, 2017

    Report

    Report Number
    2032582-2017-00004
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 28, 2017
    Report Date
    October 10, 2017
    Manufacturer
    PFM MEDICAL INC.
    Product Code
    MAE
    UDI-DI
    04042301159991
    PMA / PMN Number
    P120009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN THE COIL WAS EXTRUDED INTO THE PROXIMAL DESCENDING AORTA, THE LEADING EDGE LODGED ITSELF INTO THE AORTA. IT WAS EXTREMELY DIFFICULT TO GET OUT. DURING THE PROCESS OF ATTEMPTING TO REMOVE IT (USING CATHETERS FROM THE ARTERIAL SIDE TO PRY IT AWAY FROM THE AORTA, AS WELL AS PULLING WITH A SNARE), THERE WAS PREMATURE RELEASE OF THE DELIVERY SYSTEM FROM THE DEVICE. AT THAT POINT, DEVICE WAS HALF WITHIN THE CATHETER AND HALF OUTSIDE. PHYSICIAN WAS ABLE TO SNARE IT AND PULL IT OFF THE AORTA, AND SUBSEQUENTLY PULLED BOTH THE SNARE AND DELIVERY CATHETER BACK THROUGH THE PDA INTO THE MAIN PULMONARY ARTERY AND THEN TO THE IVC WHERE IT COULD BE DEALT WITH BETTER WITHOUT RISK OF DANGEROUS EMBOLIZATION. ONCE THERE WITHIN THE IVC, PHYSICIAN WAS ABLE TO GET A BETTER HOLD WITH THE SNARE AND PULLED IT INTO THE SHEATH. SOME CAME THROUGH AND THEN, WHILE PULLING, THE COIL BROKE IN HALF. PHYSICIAN WAS ABLE TO WITHDRAW FIRST HALF, AND THEN RE-SNARE THE REMAINING HALF AND REMOVE IT. PHYSICIAN THEN PLACED THE NEXT SIZE NIT-OCCLUD COIL AND EXTRUDED IT INTO DESCENDING AORTA. UPON PULLING BACK INTO THE AMPULLA, IT EASILY PULLED ACROSS THE PDA INTO THE PULMONARY ARTERY DESPITE HAVING REPEATED AN ANGIOGRAM AND APPROPRIATELY SIZING TO THE NEW DIAMETER. PHYSICIAN THINKS HAVING PULLED THE PREVIOUS DEVICE ALL THE WAY THROUGH WITH A SECOND CATHETER AND THE SNARE, DILATED THE PDA. PHYSICIAN THEN REMOVED THE SECOND NIT-OCCLUD COIL, AND REPLACED IT WITH AN AMPLATZER DEVICE. PATIENT (B)(6), MEASURED DUCTUS SIZE (MM): AORTIC - 2, PULMONARY - 5, LENGTH - 7. PROCEDURE DURATION: 196 MINS. PDA ACCESS: VENOUS. A 5FR INTRODUCER SHEATH WAS USED. PHYSICIAN DID NOT NOTICE HIGH RESISTANCE DURING FORWARDING OF THE SYSTEM INTO THE IMPLANTATION CATHETER. PHYSICIAN NOTICED HIGH RESISTANCE DURING RETRIEVAL OF THE SYSTEM INTO THE IMPLANTATION CATHETER. CURVATURE OF IMPLANTATION CATHETER IN THE VESSEL: MILD. PHYSICIAN DID NOT NOTICE A GAP BETWEEN PUSHER AND COIL PRIOR TO RELEASE. THE NUMBER OF REVOLUTIONS THE PHYSICIAN MOVED THE ROTATION SCREW FORWARD FOR RELEASE WAS NOT NOTED. PHYSICIAN STATED THAT THE FIRST ANGIOGRAM (BEFORE THE FIRST DEVICE) THE DUCTUS MEASURED AS NOTED, SO A 7X6 WAS USED. AN ANGIOGRAM BEFORE ATTEMPTING THE SECOND NIT-OCCLUD DEVICE SHOWED A MINIMAL DIAMETER OF 2.5 MM. PHYSICIAN USED A 9X6 FOR THAT AND IT PULLED RIGHT THROUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717355 NIT-OCCLUD PDA OCCLUDER, PATENT DUCTUS, ARTERIOSUS MAE PFM MEDICAL INC. 145076V2 1020429 04042301159991

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention