BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMPIRA RX PTCA DILATATION CATHETER

    MDR report key: 3633892 · Received January 18, 2014

    Report

    Report Number
    3004036480-2013-00013
    Event Type
    Malfunction
    Date Received
    January 18, 2014
    Date of Event
    November 5, 2013
    Report Date
    November 18, 2013
    Manufacturer
    CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
    Product Code
    LOX
    PMA / PMN Number
    K110133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED ALONG WITH THE BOSTON SCIENTIFIC DEFLATOR. THE FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED A SLIGHTLY FLARED SOFT TIP; A SMALL KINK LOCATED 3.6 DISTAL OF THE GRAFT LINE OF THE COATING AT HYPO-TUBE. IT APPEARED THAT THE BALLOON WAS INFLATED. DURING THE INVESTIGATION, THE BALLOON WAS SUCCESSFULLY INFLATED AND DEFLATED USING BOTH CTM'S AND BOSTON SCIENTIFIC'S DEFLATORS. THE SHIPPING MANDRELS WAS ABLE TO PASS THROUGH THE GUIDE WIRE LUMEN WITHOUT ANY RESISTANCE. THE DISTAL, PROXIMAL AND RX BONDS MEASUREMENTS MEET MANUFACTURING SPECIFICATIONS. UNABLE TO CONDUCT LOT HISTORY REVIEW DUE TO LOT NUMBER WAS NOT AVAILABLE. THE ANALYSIS DID NOT CONCLUDE THAT DEVICE MALFUNCTIONED. THE ROOT CAUSE IS INCONCLUSIVE. THE COMPLAINT TRENDING RATE FOR BALLOON DEFLATION DIFFICULTY OVER 18 MONTHS IS AT (B)(4). CREGANNA - TACTX MEDICAL WILL CONTINUE TO MONITOR THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED INDICATED THAT DURING PRE-DILATATION OF THE RIGHT CORONARY ARTERY (RCA), A 15 X 2.00 EMPIRA RX PTCA CATHETER BALLOON WOULD NOT DEFLATE AFTER INFLATION. THIS CAUSED THE UNKNOWN GUIDE CATHETER TO GET SUCKED DEEP INTO THE CORONARY ARTERY CAUSING DISSECTION OF THE ORIGIN. STENT PLACEMENT ALONG THE ARTERY WAS CONDUCTED TO FIX THE DISSECTION. THE PHYSICIAN STATED THAT THERE WAS NOT TOO MUCH DYE IN THE BALLOON. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE PROCEDURE WAS DELAYED BY 30 MINUTES. SINCE THE ORIGIN AND PROXIMAL AREA OF THE RCA WAS DISSECTED THE PHYSICIAN HAD TO PLACE STENTS FROM THE ORIGIN TO MID RCA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AFTER INFLATION. THIS THEN CAUSED THE GUIDE CATHETER TO GET SUCKED DEEP INTO THE CORONARY ARTERY CAUSING DISSECTION OF THE ORIGIN. STENT PLACEMENT ALONG THE ARTERY HAD TO BE DONE TO FIX THE DISSECTION. DR (B)(6) STATES THERE WAS NOT TOO MUCH DYE IN THE BALLOON. DEVICE WILL BE FORWARDED ON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46442 EMPIRA RX PTCA DILATATION CATHETER CATHETER, PTCA LOX CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL 85R15200S

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention