BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE)

    MDR report key: 8631544 · Received May 22, 2019

    Report

    Report Number
    3006260740-2019-01445
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741139079
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: SAMPLE EVALUATION, PATIENT SEVERITY, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A HOLE IN THE CATHETER WAS CONFIRMED AND THE CAUSE APPEARED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR S/L POWERPICC SOLO CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A SPLIT IN THE CATHETER SHAFT WAS OBSERVED BETWEEN THE 4-5CM DEPTH MARKINGS. THE CATHETER SPLIT WAS INDICATIVE OF FLEXURAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING) AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT.

    Description of Event or Problem · 0

    THE CATHETER WAS IMPLANTED ON (B)(6) 2019. IT PRESENTS AN ORIFICE AT 4 CM FROM THE BRAND 0. AFTER THE INFUSION IT PRODUCES EXTRAVASATION. DRUGS THAT HAVE BEEN INFUSED ARE: MYOCET AND VINCRISTINE. IT IS PENDING TO CONFIRM ABOUT POSSIBLE INJURIES WITHIN THE ARM SUBCUTANEOUS TISSUE AROUND THE CATHETER WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED, AT THIS TIME, TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF RECW1491 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. DEVICE NOT YET RETURNED.

    Description of Event or Problem · 1

    THE CATHETHER WAS IMPLANTED ON (B)(6) 2019. IT PRESENTS AN ORIFICE AT 4 CM FROM THE BRAND 0. AFTER THE INFUSION IT PRODUCES EXTRAVASATION. DRUGS THAT HAVE BEEN INFUSED ARE: MYOCET AND VINCRISTINA. IT IS PENDING TO CONFIRM ABOUT POSSIBLE INJURIES WITHIN THE ARM SUBCUTANEOUS TISSUE AROUND THE CATHEHER WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425919 POWERPICC SOLO 4F SINGLE-LUMEN CATHETER BASIC TRAY (WITH 70CM NITINOL GUIDEWIRE) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A RECW1491 00801741139079

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention