BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDSTRAND RX

    MDR report key: 4955968 · Received July 29, 2015

    Report

    Report Number
    2915056-2015-00003
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Report Date
    July 8, 2015
    Manufacturer
    GE HEALTHCARE
    Product Code
    KXK
    PMA / PMN Number
    K063177
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STRANDING MATERIAL FOR THE IMPLANTED STRANDS WAS THERAGENICS' THERASLEEVE. RISK ASSESSMENT: STRANDING OF SEEDS WITH BIO ABSORBABLE SUTURES WAS DEVELOPED 20 YEARS AGO TO REDUCE SEED MIGRATION AND IMPROVE IMPLANT DOSIMETRY. RSRX CAN BE STRANDED WITH TWO TYPES OF STRANDING MATERIAL AT THE CUSTOMER'S REQUEST. A BIO ABSORBABLE BRAIDED SUTURE COMPOSED OF 90/10 (GLYCOLIDE L- LACTIDE) FOR WHICH ABSORPTION OCCURS IN 56-70 DAYS. A BIO ABSORBABLE MONOFILAMENT SLEEVE COMPOSED OF 20/80 (GLYCOLIDE L- LACTIDE) FOR WHICH ABSORPTION OCCURS IN 140 -180 DAYS. THE FIRST TYPE OF STRANDING MATERIAL IS THE SAME AS THAT USED FOR GE/ONCURA'S P PRODUCT RAPID STRAND (IMC 7000). IT HAS BEEN IN USE FOR MANY YEARS AND NO CONFIRMED REPORTS OF WHOLE STAND SLIPPAGE HAVE BEEN DOCUMENTED. CONCLUSION: WHOLE STRAND MIGRATION IS AN UNDESIRABLE AND UNUSUAL OCCURRENCE AS A RESULT OF PROSTATE LOW DOSE RATE SEED IMPLANTATION FOR LOCALISED PROSTATE CANCER. IF NOT IDENTIFIED THE ABSENCE OR CHANGE OF LOCATION OF SEEDS IN THE PROSTATE TISSUE DUE TO MIGRATION MAY CAUSE A COLD SPOT WHICH COULD COMPROMISE THE EFFICACY OF THE TREATMENT. ADDITIONALLY THE PRESENCE OF SEEDS IN UNPLANNED AREAS OF THE PROSTATE OR NEIGHBORING STRUCTURES MAY GIVE RISE TO UNEXPECTED MORBIDITY.

    Description of Event or Problem · 1

    REPORT # 2915056-2015-00003 IS A PHYSICIAN REPORT FROM (B)(6) CONCERNING A DEVICE MALFUNCTION WITH NO ASSOCIATED ADVERSE EVENT. THE REPORT INVOLVES A MALE PATIENT (AGE NOT REPORTED) WHO EXPERIENCED SIGNIFICANT DISLOCATION FROM THE ORIGINAL IMPLANTED POSITION OF RAPID STRAND RX (RSRX) FOR THE LOW DOSE RATE BRACHYTHERAPY TREATMENT OF LOCALISED PROSTATE CANCER. CONCURRENT MEDICAL CONDITION INCLUDED PROSTATE CANCER. PAST MEDICAL HISTORY WAS NOT PROVIDED. CONCOMITANT MEDICATION WAS NOT PROVIDED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN IMPLANTATION OF RAPIDSTRAND RX FOR THE LOW DOSE RATE BRACHYTHERAPY TREATMENT OF LOCALISED PROSTATE CANCER (DOSE NOT REPORTED). THE LOT NUMBER WAS PROVIDED AS 0300134679. THE INTRAOPERATIVE FLUOROSCOPIC IMAGES SHOWED IMPLANTS WITH A SATISFACTORY DISTRIBUTION OF SEEDS. HOWEVER THE POST IMPLANT DOSIMETRY IMAGES SHOWED SIGNIFICANT DISLOCATION OF SEEDS FROM EXPECTED POSITIONS WHICH LED THE ATTENDING PHYSICIAN TO CONCLUDE THAT WHOLE STRANDS HAD MIGRATED AT AN UNDEFINED TIME AFTER THE IMPLANTATION. MEDICAL ASSESSMENT CONCLUDED: WHOLE STRAND MIGRATION IS AN UNDESIRABLE AND UNUSUAL OCCURRENCE AS A RESULT OF PROSTATE LOW DOSE RATE SEED IMPLANTATION FOR LOCALISED PROSTATE CANCER. IF NOT IDENTIFIED THE ABSENCE OR CHANGE OF LOCATION OF SEEDS IN THE PROSTATE TISSUE DUE TO MIGRATION MAY CAUSE A COLD SPOT WHICH COULD COMPROMISE THE EFFICACY OF THE TREATMENT. ADDITIONALLY THE PRESENCE OF SEEDS IN UNPLANNED AREAS OF THE PROSTATE OR NEIGHBOURING STRUCTURES MAY GIVE RISE TO UNEXPECTED MORBIDITY. OUTCOME OF THE EVENT WAS NOT PROVIDED AT THE TIME OF THIS REPORT. QUALITY ASSURANCE INVESTIGATION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2015: QUALITY ASSURANCE INVESTIGATION SUMMARY: ALL DOCUMENTS AND ALL IN PROCESS PAPERWORK WERE REVIEWED FOR TO DETERMINE IF ANY ISSUES OCCURRED DURING THE PRODUCTION AND LOADING PROCESS. THE DIGITAL IMAGES OF THE NEEDLE TRAYS SHOW THAT THE SEEDS AND SPACERS WERE BUILT PER ORDER SPECIFICATIONS IN ACCORDANCE TO THE CUSTOM NEEDLE CONFIGURATION PLANS. INSPECTION RECORDS FOR THE STRAND MATERIAL WERE REVIEWED AND APPROVED PRIOR TO THE LOADING PROCESS. THE ORDER MET ALL RELEASE SPECIFICATIONS AND REQUIREMENTS AND THERE WERE NO MANUFACTURING ANOMALIES OR UNUSUAL EVENTS DURING MANUFACTURING. QUALITY ASSURANCE INVESTIGATION FINALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494748 RAPIDSTRAND RX RADIONUCLIDE BRACHYTHERAPY SOURCE KXK GE HEALTHCARE 6711 0300134679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention