BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 9383952 · Received November 27, 2019

    Report

    Report Number
    3002124543-2019-00067
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    November 13, 2019
    Report Date
    November 19, 2019
    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: THE PATIENT EXPERIENCED INTRA-TUMORAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED BY TACE USING LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYL ESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL), WHICH WAS ACHIEVED SUCCESSFULLY. THE OUTCOME OF THE INTRA-TUMORAL HAEMORRHAGE WAS UNKNOWN. VERY LITTLE INFORMATION IS AVAILABLE FOR THIS EVENT, THE FOLLOWING IS MISSING AND HAS BEEN REQUESTED FROM THE REPORTER: PATIENT CHARACTERISTICS: AGE, SEX, COMORBIDITIES, BLEEDING DIASTHESIS, LAB TEST BEFORE TREATMENT. TUMOR CHARACTERISTICS; TYPE OF TUMOR, LOCATION, SIZE, PREVIOUS TREATMENT TREATMENT CHARACTERISTICS: BEAD SIZE, VOLUME OF BEAD USED, EMBOLIZATION END POINT, BEADS LOADED WITH DRUG OR NOT. DESCRIPTION OF THE EVENT: CLINICAL SYMPTOMS, NEEDING TRANSFUSION. THERE WAS NO DEVICE FAILURE OR MALFUNCTION REPORTED. BTG ASSESSMENT: INTRA-HUMORAL HAEMORRHAGE: SEVERITY: UNKNOWN; SERIOUS; ANTICIPATED; RELATED: DEVICE. BTG FOLLOW UP MEDICAL ASSESSMENT (B)(6) 2019 ON (B)(6) 2019: A PATIENT IN HER 60S UNDERWENT TACE USING DC BEADS. TACE WAS PERFORMED USING 4 VIALS OF DC BEADS, VIALS 1 AND 2 LOADED WITH EPIRUBICIN WHILE VIALS 3 AND 4 WERE NOT LOADED WITH DRUG. ON (B)(6) 2019: THE PUNCTUATION SITE WAS CHECKED AGAIN TO PERFORM TREATMENT, AND RESIDUAL INTRATUMOURAL HAEMORRHAGE WAS NOTED HAEMOSTASIS WAS PERFORMED BY TACE USING LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYL ESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL), WHICH WAS ACHIEVED SUCCESSFULLY. THE PATIENT RECOVERED FROM THE INTRATUMORAL HAEMORRHAGE. THERE WAS NO DEVICE FAILURE OR MALFUNCTION BTG ASSESSMENT: INTRA-HUMORAL HAEMORRHAGE: SEVERITY: 2; SERIOUS- REQUIRED INTERVENTION; ANTICIPATED; RELATED: DISEASE, THE INTRA TUMORAL HAEMORRHAGE IS LIKELY DUE TO A SPONTANEOUS BLEEDING OCCURRING IN A HUGE TUMOR, REGARDING THE AMOUNT OF BEADS USED (8ML) THIS MUST BE A HUGE TUMOR WHICH IS AT HIGH RISK OF SPONTANEOUS BLEEDING. 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 · 0

    IN (B)(6) 2019: TACE WAS PERFORMED USING DC BEADS. THE PATIENT EXPERIENCED INTRATUMOURAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED BY TACE USING LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYLESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL), WHICH WAS ACHIEVED SUCCESSFULLY. THE OUTCOME OF THE INTRATUMOURAL HAEMORRHAGE IS UNKNOWN. THERE WAS NO REPORTED DEVICE FAILURE OR MALFUNCTION. THE REPORTING PHYSICIAN DID NOT SPECIFY THE SERIOUSNESS OR CAUSALITY OF THE EVENT. ADDITIONAL INFORMATION RECEIVED ON NOV/26/2019: ON (B)(6) 2019: THE PATIENT IN HER 60S UNDERWENT TACE USING DC BEADS. DC BEAD LOADED WITH EPIRUBICIN WAS USED IN THE FIRST AND SECOND VIALS, WHILE IN THE THIRD AND FOURTH VIALS, DC BEAD LOADED WITH NO DRUG WAS USED. ON (B)(6) 2019: THE PUNCTUATION SITE WAS CHECKED AGAIN TO PERFORM TREATMENT, AND RESIDUAL INTRATUMOURAL HAEMORRHAGE WAS NOTED. HAEMOSTASIS WAS ACHIEVED BY SPONGE PRESSURE. THE PATIENT RECOVERED FROM THE INTRATUMOURAL HAEMORRHAGE. ADDITIONAL INFORMATION RECEIVED ON NOV/26/2019 REPORTER'S COMMENTS AS BELLOW: THE INTRATUMOURAL HAEMORRHAGE WAS CONSIDERED TO BE DUE TO DC BEADS.

    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 EXPERIENCED INTRA-TUMORAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED BY TACE USING LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYL ESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL), WHICH WAS ACHIEVED SUCCESSFULLY. THE OUTCOME OF THE INTRA-TUMORAL HAEMORRHAGE WAS UNKNOWN. VERY LITTLE INFORMATION IS AVAILABLE FOR THIS EVENT, THE FOLLOWING IS MISSING AND HAS BEEN REQUESTED FROM THE REPORTER: PATIENT CHARACTERISTICS: AGE, SEX, COMORBIDITIES, BLEEDING DIASTHESIS, LAB TEST BEFORE TREATMENT. TUMOR CHARACTERISTICS; TYPE OF TUMOR, LOCATION, SIZE, PREVIOUS TREATMENT. TREATMENT CHARACTERISTICS: BEAD SIZE, VOLUME OF BEAD USED, EMBOLIZATION END POINT, BEADS LOADED WITH DRUG OR NOT. DESCRIPTION OF THE EVENT: CLINICAL SYMPTOMS, NEEDING TRANSFUSION. THERE WAS NO DEVICE FAILURE OR MALFUNCTION REPORTED. BTG ASSESSMENT: INTRA-HUMORAL HAEMORRHAGE: SEVERITY: UNKNOWN; SERIOUS; ANTICIPATED; RELATED: 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

    (B)(6) 2019: TACE WAS PERFORMED USING DC BEADS. THE PATIENT EXPERIENCED INTRATUMOURAL HAEMORRHAGE. HAEMOSTASIS WAS PERFORMED BY TACE USING LIPIODOL (IODINE ADDITION PRODUCTS OF THE ETHYLESTERS OF THE FATTY ACIDS OBTAINED FROM POPPYSEED OIL), WHICH WAS ACHIEVED SUCCESSFULLY. THE OUTCOME OF THE INTRATUMOURAL HAEMORRHAGE IS UNKNOWN. THERE WAS NO REPORTED DEVICE FAILURE OR MALFUNCTION. THE REPORTING PHYSICIAN DID NOT SPECIFY THE SERIOUSNESS OR CAUSALITY OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178623 DC BEAD HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE, PRODUCT CODE: KRD KRD BIOCOMPATIBLES UK LTD UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention