BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERPORT MRI 8GS, INT. W SP, ATT S/L

    MDR report key: 19689031 · Received July 8, 2024

    Report

    Report Number
    3006260740-2024-03532
    Event Type
    Death
    Date Received
    July 8, 2024
    Date of Event
    May 29, 2023
    Report Date
    November 13, 2024
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    UDI-DI
    00801741027246
    PMA / PMN Number
    K063377
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL INFORMATION WAS RECEIVED, AND THE FILE WAS REASSESSED FOR REPORTABILITY AND DETERMINED TO BE REPORTABLE AS DEATH. H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6)1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. H10: D4 (EXPIRATION DATE: 12/2025), G2, G3, H6 (DEVICE). H11: B2, B3, B5, D4 (MEDICAL DEVICE LOT NUMBER), H1, H6 (PATIENT, RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Additional Manufacturer Narrative · 0

    H10: DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS 01-JAN-1900 FOR THE MDR SUBMISSION REQUIREMENT. H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE PROVIDED AND REVIEWED. APPROXIMATELY SIX DAYS POST PORT PLACEMENT, THE MEDICAL RECORD DESCRIBES THE CATHETER OF THE PORT BREAKING COMPLETELY SOMETIME AFTER INSERTION AND THE DISTAL PORTION OF IT MIGRATING INTO THE RIGHT HEART. THESE EVENTS ARE THEREFORE CONFIRMED. THE BACK PAIN AND PATIENT DEATH ARE NOT DESCRIBED IN THE MEDICAL RECORD AND THEREFORE CANNOT BE CONFIRMED. THE MEDICAL RECORD ALSO DESCRIBES TACHYCARDIA, WHICH CAN THEREFORE ALSO BE CONFIRMED. THE CATHETER SEGMENT AND PORT BODY WERE THEN REMOVED AND REPLACED. NO RELATIONSHIP BETWEEN THE EXPIRATION OF THE PATIENT AND THE PORT HAS BEEN CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. H10: B5, G3, H6 (PATIENT, METHOD). H11: D4 (UNIQUE IDENTIFIER (UDI) #), H6 (RESULT, CONCLUSION). H11: SECTION A THROUGH F ¿ THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE CATHETER HAD ALLEGEDLY FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FIVE DAYS LATER POST PORT PLACEMENT PROCEDURE FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY FRACTURED AND MIGRATED INTO THE RIGHT HEART. IT WAS FURTHER REPORTED THAT PATIENT DEVELOPED WITH CHEST PAIN AND LOW BACK PAIN DUE TO BROKEN CATHETER AND THAT WAS REMOVED BY SNARE. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITIGATION PROCESS THAT APPROXIMATELY FIVE DAYS POST A PORT PLACEMENT FOR CHEMOTHERAPY TREATMENT, THE PORT CATHETER ALLEGEDLY FRACTURED AND MIGRATED INTO THE RIGHT HEART. IT WAS FURTHER REPORTED THAT THE PATIENT DEVELOPED WITH CHEST PAIN, LOW BACK PAIN AND VENTRICULAR TACHYCARDIA DUE TO BROKEN CATHETER AND THAT WAS REMOVED BY SNARE. REPORTEDLY, THE PORT WAS REMOVED AND NEW PORT HAS BEEN IMPLANTED. HOWEVER, THE PATIENT WAS EXPIRED AND THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152553 POWERPORT MRI 8GS, INT. W SP, ATT S/L PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 REHN2490 00801741027246

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Death