BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC, 3CG

    MDR report key: 22203648 · Received June 13, 2025

    Report

    Report Number
    3006260740-2025-03860
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 23, 2025
    Report Date
    July 11, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741138966
    PMA / PMN Number
    K091324
    Removal / Correction Number
    MDS-24-5154-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A LEAK WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4 FR SINGLE LUMEN POWERPICC. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE MAY OCCUR 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 BREAK WAS OBSERVED NEAR THE 3CM MARKING. THE CATHETER BREAK CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL 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 REPETITIVE KINKING OF THE INDWELLING CATHETER APPEARS TO HAVE CONTRIBUTED TO THE OBSERVED LEAK; HOWEVER, THE SPECIFIC CIRCUMSTANCES SURROUNDING HOW KINKING DEVELOPED INTO A FRACTURE WITHIN THE CATHETER TUBING WERE ULTIMATELY UNKNOWN. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS, AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT WAS SCHEDULED FOR THE REMOVAL OF THE PICC, AND IN DOING SO, IT HAS HAD A COMPLETE RUPTURE 4 CM FROM THE CONE, REMAINING INSIDE THE PATIENT. AT THIS MOMENT, HE HAS AN APPOINTMENT WITH THE VASCULAR SURGEON TO PROCEED WITH ITS REMOVAL. ADDITIONAL INFORMATION RECEIVED 11-JUNE-2025: THE RETAINED CATHETER SEGMENT DID NOT MIGRATE DEEPER INTO THE PATIENT. RETAINED SEGMENT WAS SUCCESSFULLY REMOVED, HEMODYNAMICS SURGEON AND IT HAD TO BE REMOVED VIA THE FEMORAL ARTERY. COMPLICATIONS: THROMBOSIS IN THE BASILICA NEAR THE EXIT SITE. PATIENT DIDN'T SUFFER ANY DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636667 POWERPICC, 3CG PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LJS C.R. BARD, INC. (BASD) -3006260740 N/A REJR2229 00801741138966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention