BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP

    MDR report key: 21890247 · Received April 23, 2025

    Report

    Report Number
    9680794-2025-00326
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 19, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    LJS
    UDI-DI
    10801902208719
    PMA / PMN Number
    K220363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). ONE VPS RHYTHM DLX K-01352-001 STYLET NAVIGATION STYLET: .018" X 30-25/32" LG, INCLUDING (B)(6) CONNECTOR COMM: T-PORT WAS RETURNED. A VISUAL EXAMINATION OF THE STYLET AND THE CONNECTOR DID NOT REVEAL ANY OBVIOUS EXTERNAL DEFECTS OR ANOMALIES. IT WAS REPORTED "DURING A DIFFICULT PICC INSERTIONS, THE PICC WAS OBSERVED TO HAVE COILED ON THE TIPTRACKER. WHEN INSERTER PULLED BACK THE PICC BEFORE READVANCING, IT IS BELIEVED THAT THE PICC PULLED BACK OVER THE STYLET, LEAVING THE STYLET EXTENDING BEYOND THE CATHETER TIP. WHEN THE PICC WAS READVANCED INTO THE PATIENT, THE ECG SHOWED VENTRICULAR PLACEMENT. TROUBLE SHOOTING WAS PERFORMED, DURING WHICH IT WAS REALIZED THAT THE STYLET HAD LIKELY EXTENDED BEYOND THE TIP OF THE CATHETER. THE PICC AND STYLET WERE REMOVED ENTIRELY FROM THE PATIENT; THE STYLET WAS POSITIONED WITHIN THE CATHETER AND THE CATHETER WAS REINSERTED INTO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY". THE ABOVE INFORMATION SUGGESTS THE STYLET LOCATION WAS NOT SECURELY MAINTAINED BY THE T-PORT CONNECTOR. STYLET MRQ (B)(4) PARAGRAPH 8.2.3 MINIMUM RETAINER HOLDING FORCE, STATES THE PEAK FORCE TO AXIALLY SLIDE THE STYLET THROUGH THE RETAINER SHALL BE GREATER THAN OR EQUAL TO 0.5 N (APPROXIMATELY 59.98 GRAM) WHEN MEASURED AFTER AT LEAST ONE INSTANCE OF PREVIOUS RETAINER MOVEMENT. NO MOVEMENT OF THE STYLET THROUGH THE MEMBRANE OF THE T-PORT EXTENSION WAS OBSERVED WHEN A CALIBRATED 50 GRAM WEIGHT WAS ATTACHED TO THE STYLET AND THEN SUSPENDED BY ONLY HOLDING THE T-PORT CONNECTOR. THE TEST RESULTS CONFIRMED THE STYLET LOCATION WAS SECURELY MAINTAINED BY THE T-PORT CONNECTOR. THE REPORTED ISSUE WAS NOT REPRODUCED. NO PROBLEM WAS FOUND WITH THE ABILITY OF THE T-PORT CONNECTOR TO MAINTAIN THE LOCATION OF THE STYLET. A DEVICE HISTORY RECORD REVIEW PERFORMED ON THE T-PORT CONNECTOR DID NOT REVEAL ANY MANUFACTURING RELATED ISSUES. NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED "DURING A DIFFICULT PICC INSERTIONS, THE PICC WAS OBSERVED TO HAVE COILED ON THE TIPTRACKER. WHEN INSERTER PULLED BACK THE PICC BEFORE READVANCING, IT IS BELIEVED THAT THE PICC PULLED BACK OVER THE STYLET, LEAVING THE STYLET EXTENDING BEYOND THE CATHETER TIP. WHEN THE PICC WAS READVANCED INTO THE PATIENT, THE ECG SHOWED VENTRICULAR PLACEMENT. TROUBLE SHOOTING WAS PERFORMED, DURING WHICH IT WAS REALIZED THAT THE STYLET HAD LIKELY EXTENDED BEYOND THE TIP OF THE CATHETER. THE PICC AND STYLET WERE REMOVED ENTIRELY FROM THE PATIENT, THE STYLET WAS REPOSITIONED WITHIN THE CATHETER AND THE CATHETER WAS REINSERTED INTO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED "DURING A DIFFICULT PICC INSERTIONS, THE PICC WAS OBSERVED TO HAVE COILED ON THE TIPTRACKER. WHEN INSERTER PULLED BACK THE PICC BEFORE READVANCING, IT IS BELIEVED THAT THE PICC PULLED BACK OVER THE STYLET, LEAVING THE STYLET EXTENDING BEYOND THE CATHETER TIP. WHEN THE PICC WAS READVANCED INTO THE PATIENT, THE ECG SHOWED VENTRICULAR PLACEMENT. TROUBLE SHOOTING WAS PERFORMED, DURING WHICH IT WAS REALIZED THAT THE STYLET HAD LIKELY EXTENDED BEYOND THE TIP OF THE CATHETER. THE PICC AND STYLET WERE REMOVED ENTIRELY FROM THE PATIENT, THE STYLET WAS REPOSITIONED WITHIN THE CATHETER AND THE CATHETER WAS REINSERTED INTO THE PATIENT. THE CASE WAS COMPLETED SUCCESSFULLY." THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124859 ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP CATHETER, INTRAVASCULAR, THERA LJS ARROW INTERNATIONAL LLC 33F24L0502 10801902208719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED| NOT REPORTED