BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLEEK OTW PTA CATHETER

    MDR report key: 3121963 · Received May 16, 2013

    Report

    Report Number
    9616666-2013-00013
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CLEAR STREAM TECHNOLOGIES, LTD.
    Product Code
    LIT
    PMA / PMN Number
    K102035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT. THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO SHIPMENT. NO MANUFACTURING ANOMALIES WERE IDENTIFIED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. NEITHER THE DEVICE NOR IMAGES WERE RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE IFU WAS REVIEWED AND FOUND TO BE ADEQUATE. INSTRUCTIONS FOR DEFLATION AND WITHDRAWAL: "GENTLY WITHDRAW THE CATHETER. AS THE BALLOON EXITS THE VESSEL, USE A SMOOTH, GENTLE, STEADY, COUNTERCLOCKWISE MOTION. IF RESISTANCE IS FELT UPON REMOVAL THEN THE BALLOON AND THE SHEATH SHOULD BE REMOVED TOGETHER AS A UNIT UNDER FLUOROSCOPIC GUIDANCE, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND SHEATH AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTLE TWISTING MOTION COMBINED WITH TRACTION." PRECAUTIONS: "IF RESISTANCE IS FELT UPON REMOVAL, THEN THE BALLOON, GUIDEWIRE AND THE SHEATH/ GUIDE CATHETER SHOULD BE REMOVED TOGETHER AS A UNIT, PARTICULARLY IF BALLOON RUPTURE OR LEAKAGE IS KNOWN OR SUSPECTED. THIS MAY BE ACCOMPLISHED BY FIRMLY GRASPING THE BALLOON CATHETER AND SHEATH/ GUIDE CATHETER AS A UNIT AND WITHDRAWING BOTH TOGETHER, USING A GENTLY TWISTING MOTION COMBINED WITH TRACTION. BEFORE REMOVING CATHETER FORM SHEATH/ GUIDE CATHETER, IT IS VERY IMPORTANT THAT THE BALLOON IS COMPLETELY DEFLATED." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE DEVICE, THE BALLOON SEPARATED FROM THE CATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE FOR THE TREATMENT OF A CTO LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. AFTER USING A GUIDE CATHETER, A 0.014" GUIDEWIRE SUCCESSFULLY CROSSED THE LESION. THE DEVICE LOOKED NORMAL WHEN REMOVED FROM THE PACKAGING AND PREPPED NORMALLY. THERE WAS A LITTLE DIFFICULTY ADVANCING THE BALLOON OVER THE GUIDEWIRE AND ACROSS THE LESION. THE PHYSICIAN ATTEMPTED TO ADVANCE TO THE MID ANTERIOR TIBIAL ARTERY, HOWEVER THE DEVICE FAILED TO ADVANCE AND WAS NOT INFLATED. THERE WAS DIFFICULTY REMOVING THE DEVICE OVER THE GUIDEWIRE AND THEN THE BALLOON DETACHED FROM THE CATHETER AND REMAINED ON THE GUIDEWIRE. REPORTEDLY, EXCESSIVE FORCE WAS NOT USED TO REMOVE THE DEVICE. THE GUIDE CATHETER WAS USED TO REMOVED THE BALLOON THAT REMAINED ON THE GUIDEWIRE. THE GUIDEWIRE AND GUIDE CATHETER WERE PULLED OUT WITH THE BALLOON STILL ON THE GUIDEWIRE. THERE WAS NO DIFFICULTY ADVANCING THE BALLOON THROUGH THE GUIDE CATHETER. ANOTHER BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217811 SLEEK OTW PTA CATHETER LIT CLEAR STREAM TECHNOLOGIES, LTD. 50045716

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention