BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT KIT TRIPLE LUMEN. CONT: BOLT DRILL BIT DURA OPENER GUIDEWIRE STERILE

    MDR report key: 5664963 · Received May 18, 2016

    Report

    Report Number
    9617494-2016-00011
    Event Type
    Malfunction
    Date Received
    May 18, 2016
    Report Date
    April 7, 2016
    Manufacturer
    GMS-GESELLSCHAFT FUR MEDIZINISHE
    Product Code
    GWM
    PMA / PMN Number
    K002765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 27 MAY 2016. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. DHR REVIEW COULDN'T BE PERFORMED BECAUSE BATCH DOCUMENTATION IS ALREADY SENT TO ANOTHER SITE (BIOT). A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. CONCLUSION: THE CLINICALLY APPLIED PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE SPECIFIC CAUSE FOR THE PROBLEM REPORTED COULD NOT BE IDENTIFIED. IF ADDITIONAL INFORMATION IS OBTAINED, OR THE SAMPLE IS RETURNED, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THERE WAS AN ISSUE WITH THE IM3 TRIPLE LUMEN BOLT. THE PROBLEM WAS THAT THE MEDICAL TEAM HAD DIFFICULTY WITH THE REMOVAL OF THE TRIPLE LUMEN BOLT FROM A (B)(6) YEAR OLD FEMALE PATIENT. THE MEDICAL TEAM HAD FOLLOWED THE INSTRUCTIONS FOR USE (IFU) BUT WITHOUT SUCCESS; ONE HAD BEEN BROKEN. THE DEVICE WAS IN USE FOR MORE THAN 5 DAYS WHEN THE DYSFUNCTION WAS DETECTED. THE DISTRIBUTOR CONFIRMED THAT MEDICAL STAFF ARE LOOSENING THE WING NUT COMPLETELY BEFORE DISCONNECTING THE LUER LOCKS ON EACH CATHETER. ACCORDING TO THE DISTRIBUTOR, THIS TYPE OF ISSUE OCCURRED SEVERAL TIMES (BUT UNKNOWN EXACTLY HOW MANY). ADDITIONAL INFORMATION WAS RECEIVED ON 12 MAY 2016. THE PHYSICIAN HAD LOOSENED THE COMPRESSION CAP TO TAKE AWAY THE PROBES BUT IT WAS STUCK FAST AND HARD, SO HE TRIED TO LOOSEN THE COMPRESSION CAP EVEN MORE BUT THAT DID NOT HELP. SO HE PULLED IT OUT WITH MORE FORCE AND HE SUCCEEDED WITH ICP CODMAN AND MICRODIALYSIS AND THE PBO2. WHEN HE GOT THE PBO2 PROBE OUT, IT APPEARED AS IF THE INTRODUCER WAS BROKEN, HOWEVER, IT WAS NOT, BUT RATHER IT WAS A SEAL OF THE PROBE. THE DEVICE WAS IN PLACE, IN THE PATIENT FROM (B)(6) 2016. AFTER THIS EVENT, THE MEDICAL STAFF DID NOT IMPLANT ANOTHER KIT. THERE WAS NO PATIENT INJURY AND NO TREATMENT WAS REQUIRED. THE INCIDENT DID NOT IMPACT THE MONITORING OF THE PATIENT EITHER. THE DEVICE WILL NOT BE RETURNED, HOWEVER LOT NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319811 BOLT KIT TRIPLE LUMEN. CONT: BOLT DRILL BIT DURA OPENER GUIDEWIRE STERILE LICOX BOLTS CATHETERS & KITS GWM GMS-GESELLSCHAFT FUR MEDIZINISHE 170815

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR