BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSTATE SEEDING SET APPLICATOR TECHNIQUE

    MDR report key: 3557967 · Received October 4, 2013

    Report

    Report Number
    1225114-2013-00018
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    June 27, 2011
    Report Date
    October 3, 2013
    Manufacturer
    BIOCOMPATIBLES
    Product Code
    IWJ
    PMA / PMN Number
    K974118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY COMMENT. AN HCP COMPLAINED THAT THEY FELT THE NEEDLES WERE NOT SHARP ENOUGH. A SIMILAR EARLIER COMPLAINT ((B)(4)) HAD NOTED THAT THIS RESULTED IN GREATER DIFFICULT PENETRATING THE PERINEAL SKIN, AND "NEEDLE DEFLECTION/ TRAJECTORY SEEMS MORE VARIABLE". WHILE THERE IS NO MENTION OF ANY HARM OCCURRING TO ANY PT DUE TO THESE EVENTS, THE POTENTIAL FOR HARM DOES EXIST, AND THIS IS THEREFORE A REPORTABLE EVENT. IF THE NEEDLE TRAJECTORY OBTAINED BY THE PHYSICIAN IS DIFFERENT THAN THE ONE INTENDED BY THE TREATING PHYSICIAN BECAUSE OF PROBLEMS WITH THE DEVICE, SEEDS COULD INADVERTENTLY BE PLACED IN LOCATIONS OTHER THAN THAT INTENDED. THIS RAISES A NUMBER OF POTENTIAL HARM ISSUES INCLUDING INADEQUATE TREATMENT OF THE PT'S PROSTATE CANCER, RADIATION INJURY TO A STRUCTURE WHERE THE SEED WAS PLACED (OR AN ADJACENT STRUCTURE), AND POTENTIALLY AN INCREASED RISK OF SEED MIGRATION WITH ITS ATTENDANT COMPLICATIONS DEPENDING ON WHERE THE SEED MIGRATED TO. THERE IS NO EVIDENCE OF PT HARM AS RESULT OF THE EVENT EVALUATED IN THIS ASSESSMENT. AS PART OF A RETROSPECTIVE REVIEW THIS COMPLAINT WAS REOPENED FOR ADDITIONAL INVESTIGATION AND ANALYSIS. THE ADDITIONAL INVESTIGATION HAS BEEN CONCLUDED AND THIS COMPLAINT IS CLOSED. SEE ALSO (1) COMPLAINT SUMMARY REPORT (2) SIGNED MEDICAL RISK ASSESSMENT. A REVIEW OF (B)(4) GAUGE NEEDLES IN STOCK FROM THE SAME LOT USED (102993) CONFIRMED THERE WERE NO ISSUES OR NON-CONFORMANACES ASSOCIATED WITH THE PRODUCTION OF THIS LOT. A REVIEW OF THE COMPLAINT LOG FOR COMPLAINTS RECEIVED DURING THE TIME FRAME OF 2010 THROUGH 07/07/2013 INDICATED THAT THERE WERE NO PRIOR COMPLAINTS RELATING TO THIS PROBLEM, WITH THE EXCEPTION OF CO-COMPLAINT (B)(4) (CONTAINED WITHIN THE COMBINED COMPLAINT SUMMARY). A SINGLE DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED; HOWEVER A POTENTIAL CONTRIBUTORY FACTOR WAS HIGHLIGHTED WITHIN THE "PROCESS AND PROCEDURES" MAJOR CAUSE CATEGORY. INADEQUATE NEEDLE SILICONE COATING HAS BEEN IDENTIFIED AS A MOST PROBABLE ROOT CAUSE. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN HAS BEEN IDENTIFIED TO ADDRESS THE CONTRIBUTORY FACTORS IDENTIFIED AND IS SUMMARIZED WITHIN THE COMPLAINT SUMMARY REPORT. THIS COMPLAINT WAS SPECIFIC TO THE APPLICATOR TECHNIQUE NEEDLE ((B)(4)) COMPONENT OF THE ANCHORSEED APPLICATOR KIT (ASKIT) SOLD. THE APPLICATOR TECHNIQUE NEEDLE LOT NUMBER WAS (102993) AND THE DEVICE HAS A 510K NUMBER OF K974118. THE ANCHORSEED APPLICATOR KIT LOT NUMBER WAS 058778 AND HAS A 510K NUMBER OF K023179. THE MFR RISK ASSESSMENT RECOMMENDED CORRECTIVE ACTIONS INCLUDE: REVISION OF SILICONE PROCEDURE (B)(4) TO SPECIFY AMOUNT OF NEEDLES TO BE SILICONED AT ONE TIME. CONCLUSION: NO DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO THIS COMPLAINT, HOWEVER INADEQUATE NEEDLE SILICONE COATING HAS BEEN IDENTIFIED AS A MOST PROBABLE ROOT CAUSE. A CORRECTIVE ACTION HAS BEEN ASSIGNED TO REVISE THE SILICONE COATING PROCEDURE TO SPECIFY AMOUNT OF NEEDLES TO BE COATED TOGETHER OR SINGULARLY. THIS COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE LISTED OUTSTANDING ACTIONS WILL BE TRANSFERRED TO THE CAPA SYSTEM FOR MONITORING AND COMPLETION.

    Description of Event or Problem · 1

    THIS IS A MEDICAL DEVICE REPORT OF PROSTATE SEEDING NEEDLES WHERE THE NEEDLE AND TROCAR STYLET COMBINATION WAS EXTREMELY REPORTED TO BE DULL. THIS MEDICAL DEVICE REPORT WAS RECEIVED FROM THE MEDICAL PHYSICIST ON (B)(6) 2011. THE REPORTER CONFIRMED THAT THE NEEDLE AND TROCAR STYLET COMBINATION WAS DULL. NO ADVERSE EVENT OR PT HARM WAS REPORTED AS A RESULT OF THIS DEVICE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504529 PROSTATE SEEDING SET APPLICATOR TECHNIQUE MANUAL RADIONUCLIDE APPLICATOR SYSTEM IWJ BIOCOMPATIBLES PSS1720AT 102993 (NEEDLE)

    Patients

    Seq Age Sex Outcome Treatment
    1