BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EKOSONIC KIT 106CM 30CM TZ

    MDR report key: 11007911 · Received December 15, 2020

    Report

    Report Number
    2134265-2020-17306
    Event Type
    Injury
    Date Received
    December 15, 2020
    Date of Event
    November 16, 2020
    Report Date
    January 20, 2021
    Manufacturer
    EKOS CORPORATION
    Product Code
    KRA
    PMA / PMN Number
    K183361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL CODE ADDED DEVICE EVALUATION: THE INFUSION CATHETER CAME BACK FOR ANALYSIS WITHOUT THE ULTRASONIC CORE AND THE CABLES CUT OFF. THE DEVICE SERIAL NUMBER COULD NOT BE VERIFIED BECAUSE THE CABLE WAS CUT OFF. MEASUREMENTS OF THE TUBING INDICATED THE DEVICE WAS 106X30 CM IN LENGTH. BOTH MARKER BANDS WERE CONFIRMED TO BE MISSING WITH WITNESS MARKS ON THE TUBING. THE WITNESS MARKS CONFIRMED THE INITIAL SWAGING OF THE RADIO-OPAQUE BANDS. DAMAGE WAS SEEN ON THE TUBING IN THE TREATMENT ZONE REGION, LIKELY FROM THE MARKER BANDS SHEARING ALONG THE TUBING. FURTHER TOOL MARKS WERE SEEN AT 78.2 CM DISTAL TO THE STRAIN RELIEF. A KINK WAS SEEN AT 55.1 CM DISTAL TO THE STRAIN RELIEF AND THE TUBING WAS NOTED TO BE STRETCHED WITH WAVY STIFFENING WIRES THROUGHOUT THE DEVICE. THE DEVICE FAILED RING GAGE TESTING OVER THE REGIONS OF DAMAGE IN THE TREATMENT ZONE HOWEVER IT WAS NOTED THE GAGE WAS ABLE TO PASS OVER EACH WITNESS MARKS ITSELF.THERE WAS NO EVIDENCE OF MANUFACTURING ISSUES BECAUSE THE RO MARKERS WERE CONFIRMED TO BE SWAGED IN THE CORRECT POSITION. ADDITIONAL INFORMATION DETERMINED THE SHEATH USED IS NOT RECOMMENDED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MARKER BANDS EMBOLIZED IN THE PATIENT. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS PROCEDURE.THE CATHETER WAS PLACED IN THE RIGHT ILIAC VEIN VIA THE LEFT POPLITEAL VEIN. THE LEFT ILIAC WAS OCCLUDED. PATIENT HAD A PREVIOUS RIGHT ILIAC STENT. DURING PLACEMENT OF THE CATHETER, A SMALL AMOUNT OF RESISTANCE WAS NOTED IN THE BEGINNING OF CATHETER PLACEMENT. AFTER THE DISTAL PORTION OF THE CATHETER WAS THROUGH THE STENT, THEY VISUALIZED PLACEMENT UNDER FLUOROSCOPY. THE DISTAL PORTION OF THE CATHETER WAS NOTED TO HAVE GONE THROUGH THE OUTSIDE OF THE STENT AND CAUGHT ON THE STRUT. THE DISTAL MARKER BAND MIGRATED TO THE RIGHT ATRIUM OF THE HEART. THE PROXIMAL MARKER HAD NOT PASSED THROUGH THE STENT BUT CAME OFF THE CATHETER. THE PHYSICIAN WAS ABLE TO SNARE THE PROXIMAL MARKER BAND TO THE LEFT SIDE AND PLACE A STENT TO SECURE THE MARKER BAND AGAINST THE VESSEL WALL OF THE LEFT ILIAC VEIN. THE DISTAL MARKER BAND REMAINS IN THE RIGHT ATRIUM, IMBEDDED IN THE PAPILLARY MUSCLE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE MARKER BAND FROM THE HEART, BUT WAS UNSUCCESSFUL. THE PATIENT WILL RETURN IN A WEEK FOR FOLLOW UP CHEST IMAGING. NO PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO MARKER BANDS EMBOLIZED IN THE PATIENT. AN EKOSONIC CATHETER WAS SELECTED FOR USE DURING A DEEP VEIN THROMBOSIS PROCEDURE. THE CATHETER WAS PLACED IN THE RIGHT ILIAC VEIN VIA THE LEFT POPLITEAL VEIN. THE LEFT ILIAC WAS OCCLUDED. PATIENT HAD A PREVIOUS RIGHT ILIAC STENT. DURING PLACEMENT OF THE CATHETER, A SMALL AMOUNT OF RESISTANCE WAS NOTED IN THE BEGINNING OF CATHETER PLACEMENT. AFTER THE DISTAL PORTION OF THE CATHETER WAS THROUGH THE STENT, THEY VISUALIZED PLACEMENT UNDER FLUOROSCOPY. THE DISTAL PORTION OF THE CATHETER WAS NOTED TO HAVE GONE THROUGH THE OUTSIDE OF THE STENT AND CAUGHT ON THE STRUT. THE DISTAL MARKER BAND MIGRATED TO THE RIGHT ATRIUM OF THE HEART. THE PROXIMAL MARKER HAD NOT PASSED THROUGH THE STENT BUT CAME OFF THE CATHETER. THE PHYSICIAN WAS ABLE TO SNARE THE PROXIMAL MARKER BAND TO THE LEFT SIDE AND PLACE A STENT TO SECURE THE MARKER BAND AGAINST THE VESSEL WALL OF THE LEFT ILIAC VEIN. THE DISTAL MARKER BAND REMAINS IN THE RIGHT ATRIUM, IMBEDDED IN THE PAPILLARY MUSCLE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE MARKER BAND FROM THE HEART, BUT WAS UNSUCCESSFUL. THE PATIENT WILL RETURN IN A WEEK FOR FOLLOW UP CHEST IMAGING. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472253 EKOSONIC KIT 106CM 30CM TZ CATHETER, CONTINUOUS FLUSH KRA EKOS CORPORATION 500-55130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R