BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 9456801 · Received December 12, 2019

    Report

    Report Number
    3002124543-2019-00069
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    KRD
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. BTG MEDICAL ASSESSMENT 22-JAN-2020: VERY LITTLE INFORMATION IS STILL AVAILABLE FOR THE MEDICAL ASSESSMENT, ON (B)(6) 2019: A PATIENT IN HIS 60S (SEX, PATIENT CHARACTERISTICS, MEDICAL HISTORY, CON MEDICATION = UNKNOWN) UNDERWENT TACE USING DC BEADS(100 - 300 MICRON) (DISEASE CHARACTERISTICS UNKNOWN). DURING THE PROCEDURE, THE PATIENT EXPERIENCED INTRA-TUMOURAL HAEMORRHAGE AFTER INJECTION OF DC BEADS (DELAY?, SEVERITY?). HAEMOSTASIS WAS PERFORMED USING GELPART AND WAS ACHIEVED SUCCESSFULLY. ON (B)(6) 2019: THE PATIENT EXPERIENCED LIVER ABSCESS. IT IS NOT KNOWN IF THE ABSCESS OCCURRED IN THE SAME LOCATION OF TUMOR HAEMORRHAGE. IT IS LIKELY THAT THE ABSCESS HAS DEVELOPED IN THIS ISCHEMIC AREA. DRAINAGE WAS PERFORMED FOR THE EVENT. ON (B)(6) 2019: THE PATIENT RECOVERED FROM THE LIVER ABSCESS. MEDICAL ASSESSMENT: INTRA-TUMOURAL HAEMORRHAGE: SEVERITY 3; SERIOUS - YES, MEDICAL INTERVENTION FOR PREVENTION OF PERMANENT ALTERATION OF STRUCTURE/FUNCTION WAS NECESSARY; CAUSALITY: POSSIBLY DEVICE; ANTICIPATED ADVERSE EVENT. LIVER ABSCESS: SEVERITY 3; SERIOUS - YES, MEDICAL INTERVENTION FOR PREVENTION OF PERMANENT ALTERATION OF STRUCTURE/FUNCTION WAS NECESSARY; CAUSALITY: SECONDARY TO TUMOUR HAEMORRHAGE; ANTICIPATED ADVERSE EVENT. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE BATCH NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. NO CORRECTIVE/PREVENTATIVE ACTION HAS BEEN IDENTIFIED. SHOULD WE RECEIVE ANY INFORMATION TO ENABLE FURTHER INVESTIGATIONS, A FURTHER FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 0

    ON (B)(6) 2019: THE PATIENT IN HIS 60S UNDERWENT TACE USING DC BEADS. DURING THE PROCEDURE, THE PATIENT EXPERIENCED INTRATUMOURAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED USING GELPART AND WAS ACHIEVED SUCCESSFULLY. THE PATIENT RECOVERED FROM THE INTRATUMOURAL HAEMORRHAGE. ADDITIONAL INFORMATION RECEIVED ON JAN/16/2020: ON (B)(6) 2019: THE PATIENT IN HIS 60S UNDERWENT TACE USING DC BEADS(100-300 MICRON). DURING THE PROCEDURE, THE PATIENT EXPERIENCED INTRATUMOURAL HAEMORRHAGE AFTER INJECTION OF DC BEADS. ON (B)(6) 2019: THE PATIENT EXPERIENCED LIVER ABSCESS. DRAINAGE WAS PERFORMED FOR THE EVENT. ON (B)(6) 2019: THE PATIENT RECOVERED FROM THE LIVER ABSCESS. AE: CAUSALITY / SERIOUSNESS (PHYSICIAN) ASSESSMENT: INTRATUMOURAL HAEMORRHAGE: PROBABLY RELATED / NON SERIOUS. LIVER ABSCESS: POSSIBLY RELATED / NON SERIOUS. CONCOMITANT DISEASE: UNKNOWN. PAST MEDICAL HISTORY: UNKNOWN. CONCOMITANT DRUGS: IOPAUE (IOHEXOL).

    Additional Manufacturer Narrative · 1

    DC BEAD WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. BTG MEDICAL ASSESSMENT: THE PATIENT IN HIS (B)(6) UNDERWENT TACE USING DC BEADS. DURING THE PROCEDURE, THE PATIENT EXPERIENCED INTRA-TUMORAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED USING GELPART AND WAS ACHIEVED SUCCESSFULLY. THE PATIENT RECOVERED FROM THE INTRA-TUMORAL HAEMORRHAGE. THERE WAS NO DEVICE FAILURE OR MALFUNCTION REPORTED. BTG ASSESSMENT: INTRA-HUMORAL HAEMORRHAGE: SEVERITY: UNKNOWN; SERIOUS - REQUIRED INTERVENTION; ANTICIPATED; RELATED: HCC DISEASE PROGRESSION AND POSSIBLY DEVICE. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE BATCH NUMBER COULD NOT BE ASCERTAINED. NO PRODUCT MALFUNCTION/DEFICIENCY HAS BEEN IDENTIFIED. NO CORRECTIVE/PREVENTATIVE ACTION HAS BEEN IDENTIFIED. SHOULD WE RECEIVE ANY INFORMATION TO ENABLE FURTHER INVESTIGATIONS, A FOLLOW-UP REPORT WILL BE SUBMITTED. AT THIS TIME THIS REPORT IS CONSIDERED FINAL.

    Description of Event or Problem · 1

    THE PATIENT IN HIS (B)(6) UNDERWENT TACE USING DC BEADS. DURING THE PROCEDURE, THE PATIENT EXPERIENCED INTRATUMOURAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED USING GELPART AND WAS ACHIEVED SUCCESSFULLY. THE PATIENT RECOVERED FROM THE INTRATUMOURAL HAEMORRHAGE. AE: CAUSALITY / SERIOUSNESS (PHYSICIAN). INTRATUMOURAL HAEMORRHAGE: PROBABLY RELATED / NON SERIOUS. CONCOMITANT DISEASE: UNKNOWN. PAST MEDICAL HISTORY: UNKNOWN. CONCOMITANT DRUGS: IOPAUE (IOHEXOL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252452 DC BEAD HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD KRD BIOCOMPATIBLES UK LTD 100 - 300 MICRON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention