BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONCONTROL COAXIAL TRAY(11/13GA X 102/147

    MDR report key: 8566792 · Received April 30, 2019

    Report

    Report Number
    3011137372-2019-00143
    Event Type
    Injury
    Date Received
    April 30, 2019
    Date of Event
    April 11, 2019
    Report Date
    April 24, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DHR FILE IS NOT AVAILABLE FOR REVIEW IN THE US. RECEIVED FOR INVESTIGATION ONE (1) 10CM BONE ACCESS NEEDLE SET (CANNULA ONLY), AND ONE (1) 14CM TREPHINE NEEDLE (BONE LESION BIOPSY NEEDLE) FOR INVESTIGATION. UPON PHYSICAL INSPECTION THE BENT 10CM BONE ACCESS NEEDLE WAS CONFIRMED. THE BEND IS LOCATED 1.5CM FROM THE DISTAL TIP END OF THE CANNULA. A REVIEW OF THE CERTIFICATE OF COMPLIANCE COULD NOT BE ACCOMPLISHED AS THE RECORDED LOT/BATCH IS NOT VALID. THIS REPORTED INCIDENT APPEARS TO BE DIRECTED MORE AT THE DETAILED DESCRIPTION OF THE INJURY SUFFERED BY THE PATIENT THAN WHAT MIGHT HAVE OCCURRED TO CAUSE THE BEND IN THE RETURNED CANNULA. THE INITIAL DESCRIPTION REFLECTS "A SNAGGING" FELT BY THE DR. WHEN TRYING TO RETRIEVE THE TREPHINE NEEDLE. THE REASON FOR THE "SNAGGING" FEEL WAS DUE TO A BENT BIOPSY CANNULA FROM THE NEEDLE SET, WHICH WAS RETURNED AS PART OF THE SAMPLES. THEN ANOTHER REFERENCE TO "A FRACTURE OF THE DISTAL END COAXIAL THAT REMAINED IN THE BODY...." DOES THIS DISCUSSION INDICATE A "FRACTURE" OF THE TREPHINE NEEDLE? THE TREPHINE NEEDLE WAS INSPECTED UNDER MAGNIFICATION AND THERE WAS NO "FRACTURE" FOUND. CLINICAL REGULATORY REVIEW STATES IN INTERNAL NOTE # 0006 REFERENCES, "THE PATIENT SUSTAINED A BONE FRACTURE". CONTINUING WITH INTERNAL NOTE #6, REFERENCE, "THE DOCTOR ONLY TILTED THE COAXIAL NEEDLE". TILTING A NEEDLE EMBEDDED IN A BONE WILL IN FACT BEND IT. OTHER REFERENCES GO ON TO MENTION FRAGMENTS OF THE CANNULA EMBEDDED IN THE PATIENT. QUESTIONS WHETHER SURGERY WAS REQUIRED TO REMOVE THE FRAGMENT, OR NOT. CONCLUSION: IF THERE IS A "FRACTURE OF THE DISTAL END COAXIAL", THE MISSING FRACTURE CANNOT BE IDENTIFIED ON THE SAMPLE. IF THERE IS A PIECE OF THE TREPHINE NEEDLE LEFT IN THE PATIENT, THEN WHY ALL THE DISCUSSION ABOUT THE FRACTURE OF THE COAXIAL? BASED ON THE CONVOLUTED DESCRIPTION OF THE EVENT AND THE PHYSICAL INSPECTION OF THE RETURNED COMPONENTS, THIS COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TH4 VERTEBRAL BIOPSY WAS PERFORMED IN THE CONTEXT OF A HYPERMETABOLIC CONDENSING LESION CONTEXT OF PULMONARY AND PROSTATIC NEOPLASIA. TWO BONE BIOPSIES WERE PERFORMED ON THE UPPER SLOPE OF THE LESION. IT WAS ATTEMPTED TO PERFORM A THIRD BIOPSY AT THE LOWER SLOPE OF THE LESION: CAREFUL INCLINATION DOWNWARDS OF THE AXIAL AND BIOPSY TREPHINE, ADVANCING ALONG THE MARGIN WITH THE DRILL, SATISFACTORY TDM CONTROL. REMOVAL OF THE TREPHINE BIOPSY WITH THE DRIVER: AT THE TIME OF REMOVAL, THERE WAS THE SENSATION LIKE AN UNUSUAL SNAGGING FEELING. A XRAY WAS PERFORMED. THERE WAS A FRACTURE OF THE DISTAL END COAXIAL THAT REMAINED IN THE VERTEBRAL BODY AND THE RIGHT PEDICLE OF TH4 STRICT INTRAOSSEOUS POSITION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TH4 VERTEBRAL BIOPSY WAS PERFORMED IN THE CONTEXT OF A HYPERMETABOLIC CONDENSING LESION CONTEXT OF PULMONARY AND PROSTATIC NEOPLASIA. TWO BONE BIOPSIES WERE PERFORMED ON THE UPPER SLOPE OF THE LESION. IT WAS ATTEMPTED TO PERFORM A THIRD BIOPSY AT THE LOWER SLOPE OF THE LESION: CAREFUL INCLINATION DOWNWARDS OF THE AXIAL AND BIOPSY TREPHINE, ADVANCING ALONG THE MARGIN WITH THE DRILL, SATISFACTORY TDM CONTROL. REMOVAL OF THE TREPHINE BIOPSY WITH THE DRIVER: AT THE TIME OF REMOVAL, THERE WAS THE SENSATION LIKE AN UNUSUAL SNAGGING FEELING. A XRAY WAS PERFORMED. THERE WAS A FRACTURE OF THE DISTAL END COAXIAL THAT REMAINED IN THE VERTEBRAL BODY AND THE RIGHT PEDICLE OF TH4 STRICT INTRAOSSEOUS POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360457 ONCONTROL COAXIAL TRAY(11/13GA X 102/147 KNW TELEFLEX MEDICAL 102720

    Patients

    Seq Age Sex Outcome Treatment
    1