BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA DILATATION CATHETER

    MDR report key: 2449683 · Received January 31, 2012

    Report

    Report Number
    3008950987-2012-00002
    Event Type
    Malfunction
    Date Received
    January 31, 2012
    Date of Event
    December 27, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT FOR THE FIRST EMPIRA BALLOON USED TO TREAT THIS PT CAN BE FOUND IN MFR REPORT # 3008950987-2012-00001. THE RETURNED DEVICE WAS ANALYZED VISUALLY AND UNDER MAGNIFICATION. THE DEVICE ANALYSIS CONFIRMS THAT THE PROXIMAL HYPO-TUBE SHAFT WAS BROKEN AND KINKED. THERE IS NO OBJECTIVE EVIDENCE THAT THE DEVICE DID NOT MEET SPECIFICATION PRIOR TO DISTRIBUTION. THE CATHETER WAS SEPARATED AND BROKE 17.8CM DISTAL FROM THE STRAIN RELIEF. THERE WAS A KINK IN THE PROXIMAL SHAFT 16 CM DISTAL FROM THE STRAIN RELIEF. BOTH SIDES OF THE SHAFT ARE OVAL WHEN VIEWING THE BROKEN FACE, SUPPORTING A KINK PRIOR TO SEPARATION. THERE IS A KINK IN THE DISTAL SHAFT AND A SMALL WRINKLE IN THE DISTAL TIP. DEVICE ANALYSIS CONCLUDES THE LIKELY ROOT CAUSE IS THE CATHETER WAS KINKED DURING ADVANCEMENT THROUGHOUT THE VASCULATURE, THEN STRAIGHTENED, CAUSING THE SHAFT TO BREAK. DUE TO THE PROXIMAL LOCATION OF THE SHAFT SEPARATION IT IS LIKELY THAT THE SHAFT WAS NOT WITHIN THE GUIDE CATHETER AND NOT SUPPORTED DURING ADVANCEMENT. THERE IS NO CONCLUSIVE ROOT CAUSE FOR WHY THERE WAS DIFFICULTY WITH ADVANCEMENT. ALL INSPECTED AREAS MET SPECIFICATION. THE LEAKAGE REPORTED DURING INFLATION OCCURRED DUE TO THE SHAFT KINK AND SEPARATION.

    Description of Event or Problem · 1

    THE REPORT RECEIVED STATES THAT DURING ATTEMPTED PRE-DILATATION OF THE TARGET LESION THE HYPO-TUBE OF THE CATHETER KINKED (OR BENT) AND BROKE DURING TRACKING TO THE LESION. THE TARGET LESION LOCATION WAS THE CIRCUMFLEX ARTERY. THE LESION WAS DESCRIBED AS A MILDLY CALCIFIED, NOT TORTUOUS, TYPE B LESION. THE PRODUCT LOOKED PERFECT WHEN TAKEN FROM THE PACKAGING. THE PRODUCT WAS PREPPED AS PER THE IFU. THERE WAS NO LEAKAGE NOTICED IN THE SHAFT DURING PREPARATION. RIGHT RADIAL ACCESS WAS MADE WITH A 6FR SHEATH. A BMW WIRE WAS USED TO ACCESS THE LESION. A 6F GUIDEWIRE WAS USED. AFTER FAILING TO CROSS THE LESION WITH THE FIRST CATHETER, THE PHYSICIAN ATTEMPTED WITH AN EMPIRA BALLOON WHICH DID CROSS THE LESION, ALTHOUGH, IT ALSO KINKED DURING ADVANCEMENT. WHEN THE PHYSICIAN STARTED INFLATION, SHE NOTICED THAT THERE WAS A LEAK IN THE DISTAL PORTION OF THE HYPOTUBE, EXTERNAL TO THE PT. IT WAS NOTICED THAT THE CATHETER WAS BROKEN AT THE LOCATION OF THE KINK. IT WAS NOTED THAT NO EXCESSIVE FORCE WAS USED TO ADVANCE THE BALLOONS OVER THE GUIDEWIRE. THE DEVICE WAS SAFELY REMOVED FROM THE PT WITH THE BALLOON PARTIALLY INFLATED. THERE WAS NO REPORTED INJURY TO THE PT. THE PT IS CURRENTLY IN STABLE CONDITION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA RX PTCA DILATATION CATHETER LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 85R10150S CE0000245

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention