THERASPHERE
Report
- Report Number
- 3002124545-2015-00073
- Date Received
- October 14, 2015
- Report Date
- September 14, 2015
- Manufacturer
- BIOCOMPATIBLES UK LTD
- Product Code
- NAW
- PMA / PMN Number
- H980006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
THERASPHERE Y-90 GLASS MICROSPHERES FIELD CORRECTION 3002124545-21-SEP-2015-001-C. (B)(4).
THERASPHERE® Y-90 GLASS MICROSPHERES FIELD CORRECTION 3002124545-21-SEP-2015-001-C AS PER OTT-PC-15-0050, TREATING PHYSICIAN COMPLAINT: VIAL 48, LABELLED AS A 10 GBQ DOSE, GAVE A VALUE OF APPROXIMATELY HALF OF THE EXPECTED ACTIVITY FOR THIS DOSE SIZE WHEN MEASURED AT THE SITE. OTT-QE-0029 WAS ISSUED. PRODUCT WAS MANUFACTURED BY (B)(4) ON 03-SEP-2015, AND SHIPPED ON 08-SEP-2015. THE MEASUREMENT EVENT OCCURRED ON THE MORNING OF (B)(6) 2015, AM ((B)(6) LOCAL TIME). THE TREATING PHYSICIAN MADE THE DECISION TO PROCEED WITH THE ADMINISTRATION TO THE PATIENT. THE MISLABELLING ISSUE AT (B)(4) IS DEEMED TO BE AN ISOLATED EVENT BASED ON THE FOLLOWING INFORMATION: 1. PRELIMINARY INVESTIGATION RESULTS AT (B)(4) CONFIRMED THAT A DOSE STILL IN INVENTORY (AT (B)(4)) WAS LABELLED AS A 5 GBQ DOSE, HOWEVER IT MEASURED AS A 10 GBQ. THIS COINCIDES WITH THE OPPOSITE AT THE (B)(6) SITE (A 5 GBQ IN A 10 GBQ LABELLED POT). 2. MISLABELLED VIALS WERE ADJACENT TO EACH OTHER. 3. (B)(4) MEASURED ALL REMAINING PRODUCT IN INVENTORY FOR THE AFFECTED LOT 1599211 AND ALL DOSES MEASURED AS EXPECTED. 4. ALL REPORTED FIELD MEASUREMENTS TO DATE HAVE BEEN CONFIRMED TO BE ACCURATE. 5. ALL SITES RECEIVE MANDATORY TRAINING BY PROCTORS ON HOW TO CALIBRATE THEIR IN-HOUSE DOSE CALIBRATORS FOR THERASPHERE Y-90 MICROSPHERES AND THE PROCTORS ENSURE THAT THE DOSE IS MEASURED PROPERLY AS PART OF THE SUPERVISION OF THE FIRST 3 ADMINISTRATIONS. SITES ARE RECOMMENDED TO MEASURE THE DOSES PRIOR TO ADMINISTRATION. FURTHER, US NRC REQUIRES AUTHORIZED USERS TO MEASURE THE DOSE VIALS RECEIVED 6. THIS IS THE FIRST TIME THAT BTG HAS RECEIVED A COMPLAINT REGARDING A DOSE VIAL WITH MEASUREMENT ACTIVITY OUT OF SPECIFICATION. THE RISK MANAGEMENT REPORT (OTT-OT-08.002 VER.2) WAS REVIEWED AND THE HAZARD OF MISLABELLING OF LEAD POTS WAS IDENTIFIED (T25.0 AND T26.0). THE POTENTIAL HAZARD WAS OVER OR UNDER-DOSING. T25.0 AND T26.0 ARE ASSOCIATED WITH HARM #1 (UNDER-DOSING) HOWEVER, T25.0 AND T26.0 ARE NOT CURRENTLY ASSOCIATED WITH HARM #17 (OVER-DOSING). THIS WILL BE REVISED AS DOCUMENTED UNDER TASKS SECTION. THE MITIGATIONS FOR MISLABELLING OF LEAD POTS INCLUDES SITES MEASURING THE DOSE PRIOR TO ADMINISTRATION. SITES ARE TRAINED ON THIS RECOMMENDATION AND IT IS INCLUDED IN THE REFERENCE MANUAL HOWEVER IT IS NOT REQUIRED IN THE CURRENT IFU OR PACKAGE INSERT WHICH WILL BE REVISED. - REMAINING LOT 1599211 HAS BEEN QUARANTINED. - THERE WERE NINE SITES (12 TREATMENTS) WITH TREATMENTS SCHEDULED 15SEP- 2015 TO EXPIRY (18-SEP-2015). SEVEN OF THESE SITES ARE IN THE US AND WERE CONTACTED BY CUSTOMER SERVICE BY PHONE TO ENSURE THAT THEY MEASURE THE DOSE VIAL PRIOR TO ADMINISTRATION. TWO OF THE SITES ARE IN THE EU ((B)(4)) AND WERE CONTACTED BY EU CUSTOMER SERVICE ON 16-SEP-2015. - VIAL 48 WAS SHIPPED TO HONG KONG. PRODUCT FROM THIS LOT WAS ALSO SHIPPED TO THE FOLLOWING MARKETS: - (B)(4) ALL IMPACTED SITES IN THESE MARKETS HAVE BEEN NOTIFIED VERBALLY AND IN WRITING BY CUSTOMER SERVICE THAT THERE WAS A MISLABELLING ISSUE FOR ONE DOSE FROM LOT NUMBER 1599211. - A PLANNED DEVIATION HAS BEEN INITIATED BY (B)(4), REVIEWED AND APPROVED BY BTG PRIOR TO THE NEXT MANUFACTURING LOT (DEVIATION #5783). THIS DEVIATION INCLUDES NEW DETAILED WORK INSTRUCTIONS TO ENSURE ADDITIONAL INSPECTIONS ARE IN PLACE TO IMPROVE ACCOUNTABILITY OF EACH VIAL AND LABEL TO MINIMIZE THE OPPORTUNITY FOR THIS SAME ERROR TO OCCUR IN FUTURE MANUFACTURING LOTS. THERE ARE NO OTHER COMPLAINTS FROM THE FIELD REGARDING PRODUCT HAVING LOW OR HIGH ACTIVITY MEASUREMENTS IN COMPARISON TO THE LABEL FROM LOT #1599211.
THE CONTENT OF THE VIAL LABELED 10 GBQ REPRESENTED A 5GBQ. [PRODUCT LABEL ISSUE] RIGHT LOBE RECEIVED LESS THAN THE INTENDED DOSE [UNDERDOSE] CASE DESCRIPTION: INITIAL INFORMATION RECEIVED ON 14-SEP-2015: THIS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN AND CONCERNED A PATIENT OF UNKNOWN AGE AND GENDER. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6)-2015 THE PATIENT UNDERWENT RADIOEMBOLIZATION WITH THERASPHERE (INDICATION NOT REPORTED). A 2 VIALS TREATMENT WAS PLANNED, A 10 GBQ DOSE (VIAL 48) AND A 20 GBQ DOSE (VIAL 82). AT CALIBRATION BEFORE ADMINISTRATION OF THERASPHERE THE TREATING PHYSICIAN REALIZED THAT WHILST VIAL 82 WAS CALIBRATED CORRECTLY, VIAL 48 READ 0.68 GBQ WHEREAS IT SHOULD HAVE DECAYED TO 1.41. THE CALIBRATION WAS CHECKED BY 3 SENIOR PHYSICISTS AND SENIOR MEDICAL SPECIALIST. THE LABELS OF THE VIAL 48 WERE CHECKED AND IT READ 10GBQ. THE LEAD POT WAS SURVEYED AND NO LEAKAGE WAS DETECTED. AFTER DOING ADDITIONAL CALCULATIONS THE CONTENT READING CLOSELY REPRESENTED A 5GBQ (THE CALIBRATOR READING CORRECTLY 4.56GBQ), BUT THE LABEL OF THE VIAL 48 READ 10GBQ. THE TREATING PHYSICIAN DECIDED TO TREAT THE PATIENT EVEN THOUGH THE DOSE WAS LOWER THAN WHAT WAS DESCRIBED. AS CONSEQUENCE THE PATIENT WAS TREATED WITH BOTH VIALS, BUT THE RIGHT LOBE RECEIVED LESS THAN THE INTENDED DOSE. CASE COMMENT: THIS CASE DOCUMENTS AN UNDERDOSE DUE TO A MISLABELLING ISSUE WITH THERASPHERE VIAL 48. IN THE VAST MAJORITY OF CASES THERE WOULD BE NO RISK TO PATIENTS IF TREATMENT SITES, AS OUTLINED IN BTG TRAINING ON USE OF THE DEVICE, VERIFIED THE ACCURACY OF THE DOSE PRIOR TO ADMINISTRATION. IN THIS CASE THE PHYSICIAN DECIDED TO TREAT A PATIENT WITH A 5 GBQ DOSE THAT WAS LABELED AS A 10 GBQ (VIAL 48). THE IMPACT OF AN UNDERDOSE COULD BE A SUBOPTIMAL TUMOR RESPONSE TO THE TREATMENT. WITH REGARDS TO AN OVER-DOSE, PATIENTS COULD DEVELOP SIGNS AND SYMPTOMS OF HEPATOTOXICITY AND/OR RADIATION-INDUCED LIVER DISEASE MANIFESTED AS DECREMENT IN HEPATIC FUNCTION TESTS AND/OR DEVELOPMENT OF ASCITES, ENCEPHALOPATHY, JAUNDICE OR OTHER SIGNS OF POTENTIAL HEPATIC FAILURE. THIS RISK WAS MITIGATED AS THE 10 GBQ VIAL LABELLED AS 5 GBQ (VIAL 46) WAS MEASURED AND IDENTIFIED AT NORDION AND PLACED IN QUARANTINE. THIS CASE IS PART OF A FIELD SAFETY CORRECTIVE ACTION.
THE CONTENT OF THE VIAL LABELED 10 GBQ REPRESENTED A 5GBQ. [PRODUCT LABEL ISSUE], RIGHT LOBE RECEIVED LESS THAN THE INTENDED DOSE [UNDERDOSE], NO SIDE EFFECT FROM TREATMENT [NO ADVERSE EVENT]. CASE DESCRIPTION: INITIAL INFORMATION RECEVIED ON 14-SEP-2015: THIS MEDICAL DEVICE REPORT WAS RECEIVED FROM A PHYSICIAN AND CONCERNED A PATIENT OF UNKNOWN AGE AND GENDER. PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT PROVIDED. ON (B)(6) 2015 THE PATIENT UNDERWENT RADIOEMBOLIZATION WITH THERASPHERE (INDICATION NOT REPORTED). A 2 VIALS TREATMENT WAS PLANNED, A 10 GBQ DOSE (VIAL 48) AND A 20 GBQ DOSE (VIAL 82). AT CALIBRATION BEFORE ADMINISTRATION OF THERASPHERE THE TREATING PHYSICIAN REALIZED THAT WHILST VIAL 82 WAS CALIBRATED CORRECTLY, VIAL 48 READ 0.68 GBQ WHEREAS IT SHOULD HAVE DECAYED TO 1.41. THE CALIBRATION WAS CHECKED BY 3 SENIOR PHYSICISTS AND SENIOR MEDICAL SPECIALIST. THE LABELS OF THE VIAL 48 WERE CHECKED AND IT READ 10GBQ. THE LEAD POT WAS SURVEYED AND NO LEAKAGE WAS DETECTED. AFTER DOING ADDITIONAL CALCULATIONS THE CONTENT READING CLOSELY REPRESENTED A 5GBQ (THE CALIBRATOR READING CORRECTLY 4.56GBQ), BUT THE LABEL OF THE VIAL 48 READ 10GBQ. THE TREATING PHYSICIAN DECIDED TO TREAT THE PATIENT EVEN THOUGH THE DOSE WAS LOWER THAN WHAT WAS DESCRIBED. AS CONSEQUENCE THE PATIENT WAS TREATED WITH BOTH VIALS, BUT THE RIGHT LOBE RECEIVED LESS THAN THE INTENDED DOSE. FOLLOW-UP INFORMATION RECEIVED ON 16-OCT-2015: PATIENT'S DETAILS WERE PROVIDED. IT CONCERNED (B)(6) MALE PATIENT. PATIENT'S MEDICAL HISTORY INCLUDED INOPERABLE HEPATOCELLULAR CARCINOMA (RECENT DIAGNOSIS) AND (B)(6) CARRIER. PATIENT'S CONCOMITANT MEDICATION INCLUDED ANTI (B)(6) THERAPY. THE PATIENT RECEIVED THERASPHERE FOR PALLIATIVE TREATMENT OF INOPERABLE HEPATOCELLULAR CARCINOMA. THE PATIENT'S SERUM ALFA-FOETO PROTEIN (AFP) WAS ABOVE 160 MG/ML. PET CT SCAN SHOWED LARGE INFILTRATIVE LIVER TUMOUR IN THE LEFT LOBE OF THE LIVER AND SMALLER SATELLITE LESIONS IN THE RIGHT LOBE AS WELL. AT THE TIME OF REPORTING, THE PATIENT WAS STABLE. REPEATED BLOOD TESTS SHOWED DECREASING SERUM AFP LEVEL. LIVER FUNCTIONS TESTS WERE STABLE AND THERE WAS NO DETERIORATION. THE PATIENT DID NOT PRESENT SIDE EFFECT AFTER TREATMENT WITH THERASPHERE. CASE COMMENT: THIS CASE DOCUMENTS AN UNDERDOSE DUE TO A MISLABELLING ISSUE WITH THERASPHERE VIAL 48. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT AFTER THE ADMINISTRATION OF THERASPHERE. IN THE VAST MAJORITY OF CASES THERE WOULD BE NO RISK TO PATIENTS IF TREATMENT SITES, AS OUTLINED IN BTG TRAINING ON USE OF THE DEVICE, VERIFIED THE ACCURACY OF THE DOSE PRIOR TO ADMINISTRATION. IN THIS CASE THE PHYSICIAN DECIDED TO TREAT A PATIENT WITH A 5 GBQ DOSE THAT WAS LABELED AS A 10 GBQ (VIAL 48). THE IMPACT OF AN UNDERDOSE COULD BE A SUBOPTIMAL TUMOR RESPONSE TO THE TREATMENT. WITH REGARDS TO AN OVER-DOSE, PATIENTS COULD DEVELOP SIGNS AND SYMPTOMS OF HEPATOTOXICITY AND/OR RADIATION-INDUCED LIVER DISEASE MANIFESTED AS DECREMENT IN HEPATIC FUNCTION TESTS AND/OR DEVELOPMENT OF ASCITES, ENCEPHALOPATHY, JAUNDICE OR OTHER SIGNS OF POTENTIAL HEPATIC FAILURE. THIS RISK WAS MITIGATED AS THE 10 GBQ VIAL LABELLED AS 5 GBQ (VIAL 46) WAS MEASURED AND IDENTIFIED AT NORDION AND PLACED IN QUARANTINE. THIS CASE IS PART OF A FIELD SAFETY CORRECTIVE ACTION. THE FOLLOW-UP INFORMATION RECEIVED ON 16-OCT-2015 DID NOT CHANGE THE ASSESSMENT OF THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678344 | THERASPHERE | THERASPHERE | NAW | BIOCOMPATIBLES UK LTD | 10 GBQ | 1599211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |