BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROPICC

    MDR report key: 16234060 · Received January 24, 2023

    Report

    Report Number
    3015060232-2023-00003
    Event Type
    Injury
    Date Received
    January 24, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 20, 2023
    Manufacturer
    ACCESS VASCULAR INC.
    Product Code
    LJS
    UDI-DI
    00862559000487
    PMA / PMN Number
    K193015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, (B)(6) (B)(4) CALLED (B)(6) (B)(4) THAT HE HAD A PICC LINE THAT WOULD NEED TO BE REMOVED DUE TO SWELLING/REDNESS. UPON PULLING THE LINE THE NEXT DAY AND EXAMINING THE CATHETER, HE NOTICED WHAT LOOKED LIKE A PUNCTURE. THE LINE WAS PLACED ON (B)(6) 2022 AND HAD BEEN USED TO INFUSE VANCOMYCIN. NO OTHER PATIENT INFORMATION WAS PROVIDED. THE CATHETER WAS RETURNED FOR FURTHER INVESTIGATION, AND AVI RECEIVED THE SAMPLE ON (B)(6) 2023. THE FOLLOWING WAS NOTED: - ON THE UNDERSIDE OF THE CATHETER, WHICH WOULD BE IN CONTACT WITH THE PATIENT'S SKIN, A LEAK LOCATION WAS OBSERVED 0.5CM FROM THE SUTURE WING. SEE ATTACHMENT #1. - ON THE TOPSIDE OF THE CATHETER, WHICH WOULD BE AWAY FROM THE PATIENT'S SKIN, A DEFECT WAS OBSERVED 0.5CM FROM THE SUTURE WING (OPPOSITE THE LEAK NOTED ABOVE). IT IS POSSIBLE THAT A LEAK OCCURRED IN THIS LOCATION, BUT WAS LATER SEALED WITH BIOLOGICAL MATERIAL. SEE ATTACHMENT #2. THE CATHETER WAS THEN DISSECTED. AN OCCLUSION WAS FOUND STARTING 1.7CM FROM THE SUTURE WING AND CONTINUING FROM THE PROXIMAL END FOR 17.0CM (TERMINATING AT 18.7CM FROM THE SUTURE WING). SEE ATTACHMENT #3. NO OCCLUSIONS WERE FOUND FROM THE LUER TO 1.7CM FROM THE SUTURE WING, OR FROM 18.7CM TO THE DISTAL TIP. AVI WORKS WITH ARGON MEDICAL DEVICES TO KIT, STERILIZE, AND SHIP OUR PRODUCTS TO CUSTOMERS. PART OF ARGON'S KITTING PROCESS IS TO TAKE AVI CATHETER LOTS AND COMBINE THEM INTO THEIR OWN FOR CONTINUED PROCESSING. RECORDS SHOW THERE WERE THREE AVI CATHETER LOTS USED TO CREATE ARGON LOT #11423949: 10212102, 11092101, AND 11232101. FOR THIS INVESTIGATION, ALL THREE INTERNAL CATHETER LOT LHRS WERE REVIEWED AND THERE WERE NO DEVIATIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT AT LEAST ONE LEAK WAS PRESENT, AND THAT THE MOST LIKELY CAUSE OF FAILURE IS THE 17CM LONG OCCLUSION IN THE CATHETER LUMEN. PER THE HYDROPICC INSTRUCTIONS FOR USE (LS-049), WHICH IS PRINTED AND PROVIDED WITHIN EACH KIT, THE CATHETER SHOULD BE FLUSHED AFTER EVERY USE. WHEN NOT IN USE, THE CATHETER SHOULD BE FLUSHED AT LEAST EVERY 12 HOURS TO ENSURE PATENCY. DUE TO THE OCCURRENCE, SIZE, AND LOCATION (IN THE BODY OF THE CATHETER VS. THE DISTAL TIP) OF THE OCCLUSION, IT CAN BE ASSUMED THAT FLUSHING WAS NOT CONDUCTED BY THE CUSTOMER PER THE IFU.

    Description of Event or Problem · 0

    COMPLAINANT REPORTED A PICC LINE THAT NEEDED TO BE REMOVED DUE TO SWELLING AND REDNESS. UPON PULLING THE LINE AND EXAMINING IT, A DEFECT WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619397 HYDROPICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ACCESS VASCULAR INC. PICC-142 11423949 00862559000487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other