BEUDAMED
    FDA Adverse Event Other Summary report: N

    LC BEADM1

    MDR report key: 3766729 · Received April 18, 2014

    Report

    Report Number
    3002124545-2014-00002
    Event Type
    Other
    Date Received
    April 18, 2014
    Report Date
    April 8, 2014
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    HCG
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LC BEAD M1 WITH IRINOTECAN IS CONSIDERED OFF-LABEL USE. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA, HOWEVER, IT IS NOT INDICATED FOR USE WITH DRUGS. THE DEVICE HAS NOT BEEN SENT TO THE COMPANY FOR EVAL. NO BATCH REVIEW WAS POSSIBLE FOR THIS CASE AS THE LOT NUMBER COULD NOT BE ASCERTAINED. FROM THE RCA EXERCISE A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED. NO CAPA ACTIONS WERE IDENTIFIED. THE INVESTIGATION (RISK REVIEW) CONCLUDED THAT NO DEVICE FAILURE OR TREND IN TYPE OF INCIDENT HAS BEEN IDENTIFIED THEREFORE NO FIELD SAFETY CORRECTIVE ACTION OR PRODUCT RECALL IS REQUIRED. THE EVENT OF BIGEMINY IS AN UNEXPECTED RISK AND IS NOT CURRENTLY DOCUMENTED IN THE PRODUCT RISK ANALYSES OR BASELINE RISK DOCUMENTS, HOWEVER, IN BOTH THE COMPANY AND THE REPORTING PHYSICIAN'S ASSESSMENT, IT IS FELT HIGHLY UNLIKELY THAT THIS EVENT WAS RELATED TO PRODUCT DEFECT. THE BIOCOMPATIBLES MEDICAL ASSESSMENT CONCLUDED THAT THERE HAVE NOT BEEN PREVIOUS REPORTS OF SIMILAR EVENTS WITH DEBIRI. IN BOTH THE COMPANY AND THE REPORTING PHYSICIAN'S ASSESSMENT, IT IS FELT HIGHLY UNLIKELY THAT THIS EVENT WAS RELATED TO MALFUNCTION OF A BTG PRODUCT. HOWEVER, SINCE A CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE PROCEDURE CANNOT BE COMPLETELY EXCLUDED, THE COMPANY HAS DECIDED TO ASSESS THIS EVENT AS REPORTABLE. THE RADIOLOGIST STATED THAT THE MOST LIKELY CAUSE OF THE EVENT WAS INTRA-ARTERIAL LIDOCAINE. THE COMBINED INCIDENCE OF COMPLAINTS RELATING TO "PROCEDURAL COMPLICATION - CHEST PAIN AND 'HYPERTENSION" AND PROCEDURAL COMPLICATION - BIGEMINY/HYPERTENSION FROM 2004 TO (B)(6) 2014 DC/LC BEAD IS 3/242,653 OR 0.001% OF OVERALL IN-MARKET SALES.

    Description of Event or Problem · 1

    THIS COMBINED INITIAL/FINAL REPORT WAS RECEIVED FROM A US PHYSICIAN VIA THE COMPANY (B)(6) REGARDING A (B)(6) YEAR OLD (B)(6) MALE PT WHO WAS INITIATED TREATMENT WITH 50 MG IRINOTECAN IN 2 ML OF M1 LC BEADS. THE RADIOLOGIST STATED THAT THEY STAYED CONSERVATIVE WITH THE TREATMENT OF THE LEFT LOBE GIVEN PRIOR HISTORY OF RADIO-EMBOLISATION ON THE LEFT SIDE. THE CHEMOEMBOLIZATION WITH IRINOTECAN M1 LC BEADS WAS PLANNED FOR THE LEFT AND MIDDLE HEPATIC ARTERIES. UPON SELECTIVE CATHETERIZATION OF THE LEFT HEPATIC ARTERY, 1 ML OF 1% LIDOCAINE WAS SLOWLY INJECTED FOLLOWED BY CHEMOEMBOLIZATION. APPROXIMATELY 8 MINUTES FROM INITIATION OF THE CHEMOEMBOLIZATION, THE PT BEGAN TO EXPERIENCE SEVERAL ASYMPTOMATIC PREMATURE VENTRICULAR CONTRACTIONS FOLLOWED BY BIGEMINY. AT THIS POINT, CHEMOEMBOLIZATION OF THE LEFT HEPATIC ARTERY HAD BEEN COMPLETED. THE PT WAS MONITORED FOR APPROXIMATELY 10 TO 15 MINUTES AT WHICH POINT THE NUMBER OF PREMATURE VENTRICULAR CONTRACTIONS SIGNIFICANTLY DIMINISHED. THE MIDDLE HEPATIC ARTERY WAS THEN SELECTIVELY CATHETERIZED WITH 1 ML OF 1% LIDOCAINE THAT WAS SLOWLY INJECTED FOLLOWED BY CHEMOEMBOLIZATION. APPROXIMATELY 6 MINUTES LATER, THE PT AGAIN PRESENTED WITH ASYMPTOMATIC PREMATURE VENTRICULAR CONTRACTIONS WITH EXTENSIVE EPISODES OF BIGEMINY. THE PT WAS CAREFULLY MONITORED FOR APPROXIMATELY 30 MINUTES. HOWEVER, THE PREMATURE VENTRICULAR CONTRACTIONS WITH BIGEMINY CONTINUED. RADIOLOGIST STOPPED THE PROCEDURE. IT WAS REPORTED THAT THE PT RECEIVED 1.5ML OF DEBIRI BEFORE THE RADIOLOGIST DECIDED TO STOP THE PROCEDURE DUE TO BIGIMINY. THE PT WAS PLACED ON METOPROLOL. THE CARDIOLOGY CONSULT SERVICE WAS NOTIFIED AND THE PT WAS ADMITTED TO TELEMETRY. OVERNIGHT, THE PT'S RHYTHM RETURNED TO NORMAL SINUS RHYTHM. HOWEVER THE PT REMAINED RELATIVELY HYPERTENSIVE WITH SYSTOLIC PRESSURES IN THE 170'S DESPITE ADEQUATE POST EMBOLIC PAIN CONTROL WITH A DILAUDID PCA PUMP. THE FINAL OUTCOME OF THE EVENT HYPERTENSION WAS UNK AT THE TIME OF THIS REPORT. THE RADIOLOGIST STATED THAT THE MOST LIKELY CAUSE OF THE EVENT WAS INTRA-ARTERIAL LIDOCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238962 LC BEADM1 EMBOLIC AGENT HCG BIOCOMPATIBLES U.K. LIMITED 70-150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| O ZAFRAN| LEVOFLOXACIN| DEXAMETHASONE| MORPHINE| METRONIDAZOLE| D5 HALF NS WITH KCL IV| ZANTAC