BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA DILATATION CATHETER

    MDR report key: 2449659 · Received January 31, 2012

    Report

    Report Number
    3008950987-2012-00001
    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 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 SPECIFICATIONS PRIOR TO DISTRIBUTION. EVAL SUMMARY: THE PROXIMAL SHAFT (PTFE COATED HYPO-TUBE) WAS SEPARATED 17.8CM DISTAL FROM THE STRAIN RELIEF. THERE WAS A KINK IN THE PROXIMAL SHAFT 16 CM DISTAL FROM THE STRAIN RELIEF. THERE WERE TWO KINKS IN THE DISTAL SECTION OF THE DEVICE. ONCE KINK WAS LOCATED IN THE INTERMEDIATE SHAFT AND ONE IN THE DISTAL SHAFT. THERE WAS A SMALL WRINKLE NOTED 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. THE END VIEW OF THE BROKEN PROXIMAL HYPO-TUBE SHOWS ONE FACE AS OVAL, SUPPORTING A KINK PRIOR TO SEPARATION. 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. MFR REPORT # 3008950987-2012-00002 CONTAINS INFO ON A SECOND EMPIRA DEVICE USED DURING THIS PROCEDURE.

    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 GUIDE CATHETER WAS USED IN THE PROCEDURE. THE PHYSICIAN DID EXPERIENCE DIFFICULTY TRACKING THE DEVICE TO THE LESION. THE PHYSICIAN FIRST USED AN EMPIRA BALLOON THAT KINKED DURING ADVANCEMENT AND BROKE INTO TWO PIECES. THE DEVICE WAS SAFELY REMOVED. THERE WAS NO REPORTED INJURY TO THE PT. A SECOND EMPIRA BALLOON WAS USED REFER TO MFR REPORT # 3008950987-2012-00002. THE PT IS CURRENTLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPIRA RX PTCA DILATATION CATHETER PRODUCT CODE: LOX, CATHETERS PTCA LOX CREGANNA-TACTX MEDICAL 85R15200S DE0000352

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention